maternal obesity - Contemporary OB/GYN

Transcription

maternal obesity - Contemporary OB/GYN
CONTEMPOR ARY OB/GYN JUNE 2016, Vol. 61, No. 06
JUNE 2016
VOL. 61 NO. 06
Expert Advice for Today’s Ob/Gyn
For Doctors by Doctors
ContemporaryOBGYN.net
MATERNAL OBESITY
MATERNAL OBESIT Y AND THE FETAL BR AIN ◾ SCANZONI MANEUVER ◾ ACOG GUIDELINES ◾ MACR A AND THE OB/GYN
FAT AND THE FETAL BRAIN
TOLAC in the
morbidly obese
Rodney K Edwards, MD, MS
PAGE 24
Andrea G Edlow, MD, MSc, and Larissa H Mattei, BA
FIRST PERSON
Scanzoni
step by step
PAGE 37
PRACTICE MATTERS
Lessons from Lean
and Six Sigma
PAGE 28
ACOG GUIDELINES
Operative vaginal
delivery PAGE 34
CONTEMPOR ARY OB/GYN JUNE 2016, Vol. 61, No. 06
JUNE 2016
VOL. 61 NO. 06
Expert Advice for Today’s Ob/Gyn
For Doctors by Doctors
ContemporaryOBGYN.net
MATERNAL OBESIT Y AND THE FETAL BR AIN ◾ SCANZONI MANEUVER ◾ ACOG GUIDELINES ◾ MACR A AND THE OB/GYN
MATERNAL OBESITY
FAT AND THE FETAL BRAIN
TOLAC in the
morbidly obese
Rodney K Edwards, MD, MS
PAGE 24
Andrea G Edlow, MD, MSc, and Larissa H Mattei, BA
Could embryo
adoption or
donation be the
right choice for
your patients?
FIRST PERSON
Scanzoni
step by step
PAGE 37
PRACTICE MATTERS
Give them each option and every hope!
Lessons from Lean
and Six Sigma
PAGE 28
ACOG GUIDELINES
970-663-6799
www.Snowflakes.org | [email protected]
Operative vaginal
delivery PAGE 34
If your patients are struggling with infertility or are unsure
of what to do with their remaining embryos, inform them
about Snowflakes Embryo Adoption and Donation.
Over 6,000 babies
have been born as a
result of embryo
adoption & donation.
• Through embryo adoption, patients are able
to give birth to their adopted child.
• You can help patients avoid the high cost of
donor eggs with embryo adoption.
• Do your patients know about embryo
donation? Help them better understand their
embryo disposition choices.
Contact us to learn more.
970-663-6799
www.Snowflakes.org | [email protected]
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Learn why the world trusts the ThinPrep system at ThinPrep.com
EDITORIAL BOARD
HAVE A QUESTION FOR THE BOARD? SEND IT TO US AT
EDITOR IN CHIEF
[email protected]
DEPUTY EDITOR
CHARLES J LOCKWOOD, MD, MHCM
JON I EINARSSON, MD, PHD, MPH
Senior Vice President, USF Health
Dean, Morsani College of Medicine
Associate Professor of Obstetrics and Gynecology
Harvard Medical School
University of South Florida
Brigham and Women’s Hospital
Director, Division of Minimally Invasive Gynecologic Surgery
TAMPA, FL
BOSTON, MA
YOUR EDITORIAL BOARD
PAULA J ADAMS HILLARD, MD
JOHN O DELANCEY, MD
CHRISTIAN PETTKER, MD
Professor, Department of Obstetrics
and Gynecology, Chief, Division of
Gynecologic Specialties
Norman F Miller Professor of
Gynecology, Director, Pelvic
Floor Research, Group Director,
Fellowship in Female Pelvic
Medicine and Reconstructive
Surgery
Associate Professor, MaternalFetal Medicine, Department of
Obstetrics, Gynecology and
Reproductive Sciences
Stanford University
School of Medicine
STANFORD, CA
University of Michigan
Medical School
HAYWOOD L BROWN, MD
ANN ARBOR, MI
F. Bayard Carter Professor and
SARAH J KILPATRICK, MD, PHD
Chair, Obstetrics and Gynecology
Duke University Medical Center
Helping Hand Endowed Chair,
Department of Obstetrics and
Gynecology
DURHAM, NC
ILANA CASS, MD
Cedars-Sinai Medical Center
Vice Chair, Associate Clinical
Professor, Department of Obstetrics
and Gynecology
LOS ANGELES, CA
STEVEN J ORY, MD
Cedars-Sinai Medical Center
Professor of Obstetrics and
Gynecology
LOS ANGELES, CA
Yale School of Medicine
NEW HAVEN, CT
SHARON T PHELAN, MD
Professor, Department of
Obstetrics and Gynecology
University of New Mexico
ALBUQUERQUE, NM
JOE LEIGH SIMPSON, MD
Executive Associate Dean for
Academic Affairs, Professor of
Obstetrics and Gynecology,
and Human and Molecular
Genetics
JOSHUA A COPEL, MD
Florida International University
Florida International University
College of Medicine
Professor, Obstetrics, Gynecology,
and Reproductive Sciences, and
Pediatrics
MIAMI, FL
MIAMI, FL
Partner
IVF Florida
Yale School of Medicine
MARGATE, FL
NEW HAVEN, CT
FOUNDING JOHN T QUEENAN, MD
EDITOR Professor and Chair Emeritus, Department of Obstetrics and Gynecology
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2
CONTEMPOR ARYOBGYN.NE T
JUNE 2016
CANCER RISK AND SCREENING
LabCorp and Integrated Genetics, a member of LabCorp’s
Specialty Testing Group, take a personal approach to
laboratory testing by offering a comprehensive test
portfolio for breast, ovarian, and cervical cancer. Our
test options—combined with an extensive network of
genetic counselors—provide you and your patients with
information needed about their health.
We take a personal
approach
to laboratory testing.
BRCAssureSM– BRCA 1 and 2 analysis for hereditary
breast and ovarian cancer
Patients with BRCA mutations are at increased risk
for breast, ovarian, and other cancers. Knowing
your patients’ BRCA mutation status may assist in the
development of tailored prevention or treatment
strategies. LabCorp offers a suite of BRCAssure tests
to meet your patients’ needs.
Age-based test protocol for cervical cancer
and STD screening
Age-based approach for HPV, Pap, and Ct/Ng provides
an additional tool to help physicians manage their
patients according to a patient’s age. LabCorp
based its test protocol on the American College of
Obstetricians and Gynecologists' guidelines.1,2
ROMA® - Risk of Ovarian Malignancy Algorithm
For women who present with a pelvic mass, ROMA
combines the ARCHITECT® CA 125 IITM and Fujirebio
Diagnostics HE4 with menopausal status to help
physicians assess risk stratification of women over
age 18 for whom surgery is planned, helping to
predict ovarian cancer in women with a pelvic mass.
To learn more about the test options,
visit www.LabCorp.com.
1. American College of Obstetricians and Gynecologists. Screening for Cervical Cancer. ACOG Practice
Bulletin N° 131, November 2012. Obstet Gynecol. 2012 Nov; 120(5):1222-1238.
2. American College of Obstetricians and Gynecologists. Primary and Preventive Care: Periodic Assessments. ACOG Committee Opinion N° 483, April 2011. Obstet Gynecol. 2011 Apr; 117(4):1008-1015.
©2015 Laboratory Corporation of America® Holdings All rights reserved. 13525-0115#2
ROMA is a registered trademark, and CA 125 II is a trademark, of Fujirebio Diagnostics, Inc., Malvern, Pa. ARCHITECT is a
registered trademark of Abbott Laboratories.
PRECAUTION: ROMA should not be used without an
independent clinical/radiological evaluation and is not intended
to be a screening test or to determine whether a patient
should proceed to surgery. Incorrect use of ROMA (HE4 EIA +
ARCHITECT® CA 125 II ) carries the risk of unnecessary testing,
surgery, and/or delayed diagnosis.
TM
IN THIS ISSUE
june 2016
VOLUME 61 | NUMBER 06
PEER-REVIEWED
Maternal obesity and
the fetal brain
24
ANDREA G EDLOW, MD, MSC,
AND LARISSA H MATTEI, BA
RODNEY K EDWARDS, MD, MS
In certain subsets, planned
cesarean delivery is the safest
route.
A look at how obesity in
the mother affects a fetus’s
neurodevelopment.
28
PRACTICE MATTERS
Lean and six sigma
for your practice
34
THOMAS LEE, MD, MBA
The concepts of Lean and Six
Sigma can be used by clinicians
on the front lines to begin to
change how their practices
operate.
06
10
DR. LOCKWOOD’S TAKE
ACOG GUIDELINES
The lost art of
operative vaginal
delivery
Editor in chief Charles J
Lockwood, MD, MHCM,
provides commentary on
ACOG Practice Bulletin No. 154:
Operative Vaginal Delivery.
48
LEGALLY SPEAKING
CHARLES J LOCKWOOD, MD, MHCM
ANDREW I KAPLAN, ESQ
Even if you see few Medicare
patients, you’ll need to start
preparing for value-focused
payment.
Did induction cause this uterine
rupture?
44
CAREERS/ADVERTISER INDEX
READERS REACT
Should some morbidly
obese women forgo
labor?
36
FIRST PERSON
The Scanzoni
maneuver: get a
handle on it
SARAH CIGNA, MD, MS,
NANCY D GABA, MD,
AND JOHN W LARSEN JR, MD
An illustrated step-by-step guide
to performing this underused
forceps turn.
OUR MISSION For nearly a half century, busy
practitioners have trusted Contemporary
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into outstanding patient care. We
are dedicated to providing them with
evidence-based information on scientific
advances in a clinically useful format.
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JUNE 2016
ILLUSTRATION BY ALEX BAKER, DNA ILLUSTRATIONS, INC.
16
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DR LOCKWOOD’S TAKE
by CHARLES J LOCKWOOD, MD, MHCM
MACRA primer for ob/gyns
Even if you see few Medicare patients, start preparing for value-focused payment.
B
ack in 1997, when
healthcare consumed 13.2% of the
GDP, there were dire
warnings about the
unsustainable costs of Medicare. In
response, Congress enacted the Balanced Budget Act, which contained
a provision termed the Sustainable
Growth Rate (SGR). The SGR formula
was designed as a politically risk-free
mechanism for legislators to limit
Medicare spending. The idea was that
if physician costs exceeded targets, an
across-the-board reduction in Medicare payments to physicians would
be automatically triggered unless
actively overruled by Congress.
Thus began an annual kabuki
dance in which physicians were
threatened with outlandish cumulative cuts in their Medicare payments—often over 20%, due to outof-control costs. However, magically
at the 11th hour, we were habitually
“saved” and grateful to receive some
de minumus increase. Worse, this
exercise in futility did nothing to
restrain healthcare costs. In 2014, US
healthcare spending grew at 5.3%,
totaling more than $3 trillion or $9523
per person and accounting for 17.5%
of GDP.1 Well, the good news is that
in April 2015, Congress repealed the
SGR. The bad news is that it was replaced by a potentially more onerous
6
CONTEMPOR ARYOBGYN.NE T
Maternal obesity and the fetal brain A look at how obesity in the
mother affects a fetus’s neurodevelopment. Read more on page 16.
MY MUST
READS
Morbidly obese gravidas: Labor or not? In certain subsets,
planned cesarean delivery is the safest route.. Read more on page 24.
and very complex piece of legislation:
the Medicare Access and CHIP Reauthorization Act, or MACRA for short.
What is MACRA?
While MACRA ends the hated SGR
formula, its leitmotif is the generation
of accelerating financial pressure and
administrative burdens designed to
drive physicians from their comfort
zone of traditional fee-for-service
payments to either partially at-risk
value-based payments (VBPs) or
more fully at-risk (ie, capitated) advanced alternative payment models.
Fundamentally, MACRA is designed to slow annual Medicare
spending increases, which currently
run at a 5.5% compound annual
growth rate and account for 20% of
total national health expenditures.1
It also is designed to unify the current patchwork of Medicare physician VBP programs including the
Physician Quality Reporting System
(PQRS), the Value-based Payment
Modifier and, perhaps most hated,
the Electronic Health Record Meaningful Use Incentive Program.
Finally, it should be noted that the
enabling legislation passed overwhelmingly with strong bipartisan
support, so it is unlikely to go away
regardless of which party wins our
increasingly bizarre presidential
“reality show” contest or whether the
Accountable Care Act endures beyond January 2017. So I would advise
you to read on.
How will MACRA work?
While its final rules may change, at
its core, MACRA streamlines current
VBP programs into 2 distinct pathways: 1. the Merit-Based Incentive
Payment System (MIPS), an incremental strategy linking physician
reimbursement to both increases
in the quality (ie, patient safety and
outcomes) and reductions in cost of
care, but retains a fee-for-service payment structure; and 2. the Advanced
Alternative Payment Model (APM),
which builds on current accountable
care organizations, bundled payments, and patient-centered medical
homes to encourage partial or fully
capitated care administered through
large, clinically integrated provider
networks. All physicians caring for
JUNE 2016
MACRA
TABLE
MIPS performance categories
Clinical
Variable
Weight in
year one
Clinical prac- 15%
tice improvement activities
Methodology
This is simply a measure of continuous quality
improvement efforts and will require tracking safety
parameters and/or outcomes in response to interventions. Physicians will be able to select activities that
match practice patterns and goals from a list of over
90 options.
Advancing
care informatics (EHR
meaningful
use)
25%
This set of variables will parallel current meaningful
use provisions (eg, electronic prescribing, provider
order entry, patient portal use, patient data safeguards, disease registries, etc.) with the ability of
SK\VLFLDQVWRFXVWRPL]HPHDVXUHVWKDWUHÁHFWWKHLU
day to day practice but with an emphasis on interoperability and information exchange.
Quality of
care
30%
These mostly process of care metrics will be modHOHGDIWHU3456HJXVHRIÁXDQGSQHXPRQLDYDFcines, cancer screening tests, medication reconciliation, appropriate management of heart disease).
Physicians will be able to report 6 measures from a
UDQJHRIVSHFLDOW\DQGSUDFWLFHVSHFLÀFRSWLRQV
Cost
(resource
utilization)
10%
This is a comparison of the cost of your care for
Medicare patients compared to national peers. This
category will be based on Medicare claims for 40
HSLVRGHVSHFLÀFPHDVXUHVWRDFFRXQWIRUGLIIHUHQW
specialties. On the bright side there would be no
reporting requirements for doctors (but on the other
hand you will have to rely on the accuracy of our
federal government).
Source: US Department of Health & Human Services2
Medicare patients will have to choose
one of these 2 paths well before 2019.
Merit-Based Incentive Payment System (MIPS)
I believe that the majority of physicians are likely to initially choose
the MIPS path as it is essentially an
aggregation of 3 different programs
about which many physicians have
JUNE 2016
some knowledge and/or already participate.
On an annual basis, physicians
will submit process and outcome
measures, proof of quality assurance
efforts and electronic health record
(EHR) adoption data to the Centers
for Medicare and Medicaid Services
(CMS) which will, in turn, assess all
related Medicare claims to determine
DR LOCKWOOD’S TAKE
the total costs of a physician’s care.
CMS will use a weighted composite score to compare all physicians,
which will determine whether a bonus or penalty is due (Table).
The mean composite score for
all MIPS-eligible physicians will be
calculated for the prior performance
period. Payment adjustments will be
based on a sliding-scale bell-shaped
curve such that physicians who score
at the threshold will receive no payment adjustment, those above the
mean will receive a positive adjustment on each Medicare Part B claim
for the following year, and those below the mean will receive a negative
adjustment the following year.3 The
delta in payments will increase from
±4% in 2019 to ±9% in 2022. However, the expectation is that so many
participants will be penalized or not
receive bonuses that, in order to remain revenue neutral, higher bonuses
can be provided to exceptionally highquality providers—up to 27% by 2025.
Finally, it is expected that the weighting of measures will change over time
and that the composite mean will also
frequently change based on continuous improvements by all participants.
The baseline MIPS physician fee
schedule will increase annually by
0.5% from 2015 through 2019 with
no increases from 2020 through 2025
and a minimal 0.25% annual increase
at and after 2026. But don’t despair,
there are likely to be physician exemptions from MIPS, including those
in their first year of practice, those
working in rural or Federally Qualified Health Clinics and, obviously,
those participating in advanced
APMs.3 In addition, physicians with
very low Medicare volumes may also
be exempted, an exception that may
CONTEMPOR ARY OB/GYN
7
DR LOCKWOOD’S TAKE
be particularly relevant to ob/gyns.
Advanced Alternative Payment
Model (APM)
Given the relatively flat and at-risk fee
schedules inherent in MIPS, you may
be interested in how the alternative
pathway works. The advanced APM
path is designed for physician groups
that are already accepting some form
of risk in their payments (eg, Accountable Care Organizations [ACOs]
or bundled payments). While only
about 30% of Medicare payments are
currently funneled through advanced
APMs,4 CMS has clearly indicated its
intent is to move more and more physicians in this direction.
Providers opting to pursue the
MACRA
schedule growth rate will be substantially higher for qualifying advanced
APM participants than for MIPS
providers (0.75% vs 0.25%). However,
there is always a potential to lose
money by taking risk and then not
providing the requisite value (ie, having low quality and/or high cost).
Yet to be determined is how CMS
will manage “collisions” of alternative payment models.4 For example,
groups of primary care physicians
participating in a low-cost ACO may
be concerned that referring their
patients to specialist physicians
participating in a fixed-cost bundled
payment program will reduce their
ability to “gain-share” through cost
reductions. Such potential conflicts
IF YOU HAVEN’T REPORTED DATA ON QUALITY MEASURES
THROUGH PQRS OR AS PART OF EHR MEANINGFUL USE,
DO SO ASAP.
advanced APM path will be excluded
from MIPS adjustments. Instead,
they will receive an annual incentive
bonus consisting of 5% of their previous year’s total aggregate Medicare
expenditures.
To qualify for these enhanced payments, your APM must use similar
quality measures employed by MIPS,
employ an EHR, incur more than a
“nominal financial risk” or already
constitute a patient-centered medical home.3 Once physicians reach a
threshold percentage of their Medicare payments through an approved
advanced APM (25% in 2019 and
75% in 2023), they will be considered
“qualifying participants.”4 Importantly, starting in 2026, the annual fee
8
CONTEMPOR ARYOBGYN.NE T
will need to be resolved by CMS prior
to full implementation.
Take-home message
Most US physicians taking care of
Medicare patients will soon need to
choose between MIPS and advanced
APM pathways. In addition, even if
you are an ob/gyn who cares for few
Medicare patients, many commercial
plans are likely to adopt a similar payment strategy. Importantly, you really
need to at least tentatively choose
between pathways by 2017 because
data upon which CMS will calculate
composite value scores will start to be
collected then.
In other words, physicians must
begin the race toward value immedi-
ately. So if you haven’t reported data
on quality measures through PQRS or
as part of EHR meaningful use, do so
ASAP. Finally, many of your patients,
when confronted by the choice between high-deductible, high co-pay,
and high-premium plans versus lower-cost, capitated “HMO-like” plans,
managed by clinically integrated networks of providers, will likely choose
the latter. Thus, if you are not part of
such a network, you may find yourself
with a lot fewer patients in 2019. REFERENCES
1. Centers for Medicare & Medicaid Services. National Health Expenditure Data. https://
www.cms.gov/Research-Statistics-Data-andSystems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsHistorical.html. Accessed June 1, 2016.
2. US Department of Health & Human SerYLFHV$GPLQLVWUDWLRQWDNHVÀUVWVWHSWRLPSOH
ment legislation modernizing how Medicare
pays physicians for quality. http://www.hhs.
gov/about/news/2016/04/27/administrationWDNHVÀUVWVWHSLPSOHPHQWOHJLVODWLRQPRG
ernizing-how-medicare-pays-physicians.
html. Accessed June 1, 2016.
3. AAFP.org. MACRA Ready: Frequently
Asked Questions: Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA). http://
www.aafp.org/practice-management/payment/medicare-payment/faq.html. Accessed
June 1, 2016.
4. Mechanic RE. When new Medicare
payment systems collide. N Engl J Med.
2016;374(18):1706–1709.
Dr Lockwood, editor in chief, is Senior Vice
President, USF Health, and Dean, Morsani
College of Medicine, University of South
Florida, Tampa. He can be reached at
[email protected].
JUNE 2016
PIONEERS
ONSITE MAMMOGRAPHY
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O N s i t e M a m m ogr a ph y. co m
READERS REACT
have a comment?
SEND YOUR THOUGHTS TO [email protected]
Cesarean best practices panel needed
PEER-REVIEWED
PEER-REVIEWED
read with interest the article
In my view if your cesarean secon cesarean sections [“Cetion rate is 38%, you aren’t even
1.3 MILLION
The cesarean
sarean epidemic: Are we
trying. So don’t pretend. Primary
epidemic: Are we
too quick to cut?
too quick to cut?,” April 2016
cesarean section rates nationally
Contemporary OB/GYN] I am
are reported as 22%. These numretired now, [but] I was very inbers use wrong denominators. It is
I
CESAREAN DELIVERY RATES IN THE UNITED STATES, 1991-2007
terested in my cesarean section
not 22/100; it is really 22/40 or 45,
rates [during my career] and so
depending on the percent of priI am beyond disappointed now
miparas in the population. Now
to see a 50% increase in overall
you are pushing rates of 50%.
rates. Although there are numerous countervailing forces
Richard W Zalar, Jr, MD, FACOG
UNIVERSITY CITY, MISSOURI
which complicate any attempt to a
READ THE ARTICLE AND LET US
lower and more reasonable rate, there
KNOW WHAT YOU THINK.
are still some OBs who achieve this
CONTEMPORARYOBGYN.NET/CESAREAN-EPIDEMIC
safely. These days cesarean sections
are not epidemic, they are endemic.
I would like to propose that Contemporary OB/GYN convene a best pracHorrendous complications are distices panel to hear what some in the
qualifiers—your call.
trenches actually do successfully.
Discussions can include profesThere should be 3 to 5 panel memsional philosophies, interpretations of
bers. Start at the top with laborist or
recent positions by ACOG and SMFM,
laborist-style (in the hospital) OBs and
what works (maybe some clinical
skilled anesthesia available (epidurals
pearls; remember them?), managethat tailored for labor; a sensory, not
ment examples—what would you do?
motor block.) They should be preferLater panels can address less optit is always interesting to review arably at least 40 years old (some expemal practice settings and what can be
ticles like this as I think we keep on
rience, not fresh out of training). They
achieved or not.
digging into a problem that has no
should have a backlog of at least 500
If the average national cesarean
real solution as training and unrealisdeliveries that can be documented
rates are 32%–33%, that also means
tic expectations have taken obstetrics
(again not from training; even hosthere are significant numbers of OBs
to a different field of play.
pital administrative data have been
that have even higher rates. In my
Fear of litigation, lack of training on
easy enough to obtain for at least 2
old group, 62% of mothers would deoperative deliveries, lack of training
decades).
liver within 12 hours no matter what.
on difficult deliveries, lack of incenPrimary cesarean section rates
It might be cost- and health-effective
tives for trial of labor after cesarean
should be half the national average;
to start a timer on admission and after
section, and so on and so forth weigh
this means around 11%. Management
12 hours just cut. It would at least be
on the increase cesarean section we
of first labor should be emphasized.
honest.
I
CESAREAN DELIVERY RATES
OBSTETRICS
pelvic disproportion, or arrest of progress in labor. It is unlikely that maternal
pelvis size has changed over the past
3 decades, but it is possible that birth
weight has increased. In fact, evidence
suggests that rates of macrosomia have
increased over the past 2 decades.8
Other issues that contribute to increasing rates of cesarean delivery, possibly through the mechanism of birth
weight, are maternal obesity and gestational weight gain.9,10 Without question,
the proportion of obese women has increased over the past decade and higher weight classes are associated with
even higher rates of cesarean.11,12 In
addition, increased gestational weight
gain has been associated with cesarean
delivery and is commonly above standard guidelines.13
Another reason for increasing cesarean rates may be a rise in elective
cesarean delivery, also known as cesarean delivery by maternal request
Cesarean delivery may be a safe alternative to vaginal delivery
but
its use in 1 of 3 women giving birth in the US seems too
high.
by AARON B CAUGHEY, MD, PHD
QUICK
TAKE
Maternal obesity and gestational weight gain
may be contributing to
rising rates of cesarean delivery.
The most common indications for cesarean
delivery are prior
cesarean, failure to progress, and abnormal fetal heart
tracing.
ingly, the rise in TOLAC was accompanied by a slight decline in primary
cesarean deliveries.4 In the 1990s, the
increasing rates ran contrary to guidance from Healthy People 2010 (and
then Healthy People 2020), which set a
15% goal for primary cesareans.5
The wide variation in cesarean rates
among institutions is striking.6 The
rate varies significantly even when
controlling for characteristics that
would account for indicated cesar-
DR CAUGHEY is Professor and Chair, Department of Obstetrics
Science University, Portland, Oregon.
He reports ownership interest in MindChild Medical, Inc.
eans. The statistics are dramatic and
concerning, leading to these key questions: Why is the cesarean rate rising,
and is the rise influencing maternal or
neonatal outcomes?
vaginally. Thus, even in this setting,
it is unclear that maternal preferences
are driving the increase in cesarean
delivery rate.
The topic of CDMR led to a National
Institutes of Health (NIH) state-ofthe-science conference in 2006. The
conclusion from this meeting was
that future research was necessary to
examine both the “current extent of
CDMR and attitudes about it.”16 More
recently, a study in the United States
found that the vast majority of women
would prefer to deliver vaginally.17
So, while some maternal demoCONTINUED ON PAGE 18
15
7
23 22 22
24
21 21 21 21 21 22 23
Why is the rate rising?
One possible reason for the rise in the
cesarean delivery rate may be that there
has simply been a rise in the need for
cesarean. The most common indication for a primary cesarean is cephalo-
and Gynecology, School of Medicine, Oregon Health &
26
32
30 31
28 29
CESAREAN
RATES PEAKED
IN 2009 AT 32.9%,
CAPPING STEADY
INCREASES THAT
STARTED IN
1996
Per 100 births
n 2014, 1.3 million women in
the United States delivered via
cesarean, placing the rate at
32.2%, down just .7% from the
peak in 2009.1 That year, cesarean rates hit 32.9%, capping steady increases that started in 1996, when the
rate was 20.7%.2 The rapid rise (a 50%
increase over 13 years) came on the
heels of a decline in the cesarean rate
from 23.7% in 1987 to 20.8% in 1997—
the only time in the past 3 decades that
it fell in a developed country.3 The drop in the late 1980s and early 1990s was accomplished primarily
because trials of labor after cesarean
(TOLACs) had been rare and the rate
of attempts rose to more than 40% in
women with prior cesareans. Interest-
WOMEN IN THE UNITED STATES DELIVERED
VIA CESAREAN IN 2014
(CDMR). Because there was no ICD9 code for CDMR, it is unclear what
proportion of cesareans are due to it.
One recent study, however, estimated
the proportion as high as 4% in the
United States.14 Interestingly, CDMR
is more common in other countries,
such as Brazil, Taiwan, and Chile. A
study in Chile comparing women receiving private care (cesarean rate
>40%) to women receiving public care
(cesarean rate <20%) found that 8% of
those receiving private care and 11%
of those receiving public care stated a
preference for cesarean delivery, with
the vast majority preferring to deliver
1991
1992
and Celmatix, Inc.
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
SOURCE:CDC/NCHS, National Vital Statistics System
14
CONTEMPOR ARYOBGYN.NE T
APRIL 2016
APRIL 2016
CONTEMPOR ARY OB/GYN
15
Familiarity
with forceps
helps keep
rate low
I
10
CONTEMPOR ARYOBGYN.NE T
JUNE 2016
CESAREAN RATES
currently observe.
The attitude, as one of my senior
residents used to say when I was in
training, is that in obstetrics there are
only 2 options: an easy vaginal delivery or an easy cesarean section.
Of the group currently delivering at
my institution in Washington State, I
think only a couple of us do forceps
deliveries and I dare to say that I am
the only one in town who is comfortable with mid-pelvis forceps deliveries, which have helped me to keep a
reasonable primary cesarean section
rate.
Tomas A Hernandez-Mejia, MD
PASCO, WASHINGTON
No incentives for VBACs
S
ince VBACs are now frowned
upon, physicians will not do
them. In fact, there is no incentive to do them. You have to spend
much more time in labor and delivery
because you have to be “readily available.” If you are a solo practitioner, you
basically have to close down your office and babysit that one patient. You
do not get reimbursed for all of the extra time, in fact you get reimbursed as
if it was a routine vaginal delivery.
On another point, reimbursement
for a cesarean section is a lot more
than that for a vaginal delivery. With all
Obstetricians condemned
to defensive position
V
ery well done, Dr Caughey.
American ob practice fell off the
cliff with the universal adoption
of screening EFH rate monitoring and
surrendering to the recommendation
that operative obstetrics was not to be
practiced. Through an inherent fault,
ob is the specialty that has the fewest
number of “Level A” research articles
and guidance. Yet our specialty societies write opinions that are understandably broad yet are fodder for the nefari-
HAVE
YOUR
SAY
ONLINE
JUNE 2016
READERS REACT
ous few who are self serving and yield
to the interests of those who pay them.
The collateral damage is measurable
and has had a deleterious effect on ob
practice in this country.
Unfortunately, and as a direct result of this perverse setting, our society is now conditioned to judge our
care (quality) simply on the basis of
outcome. The concept that pregnancy has no risk and a satisfactory outcome is certain condemns us to a de-
of the healthcare cuts and reimbursements down, why on earth should a
physician ever do a vaginal delivery?
I am not an advocate of practicing this way and I still do VBACs, I do
spend a lot of time with these patients
and I am proud to say that I have one
of the lowest cesarean section rates in
the country.
I am just giving reasons why I think
that the cesarean section rate is higher
than it should be.
Patrick Skulemowski, DO
BROWNSVILLE, TEXAS
fensive position. In this scenario, we
have historic ob provider burnout and
unhappiness.
If we were once again allowed to
practice low-intervention ob and
judged on the basis of best practice
without Monday morning quarterbacking, we could make significant
progress in lowering the cesarean delivery rate to the levels of 35 to 40 years
ago without jeopardizing outcomes.
Armando P Russo, MD
VINELAND, NEW JERSEY
CONTINUED ON PAGE 15
Do you think a best practices panel would be effective? Do you feel that more frequent use of forceps could help
keep the cesarean rate down? What’s your opinion on reimbursement for VBACs? Let us know what you think by
tweeting to @ContempOBGYN.
CONTEMPOR ARY OB/GYN
11
Cervical ripening with
CONTROL AT HAND
CERVIDIL is easy to insert and remove1
INDICATION
CERVIDIL Vaginal Insert (dinoprostone, 10 mg) is indicated
for the initiation and/or continuation of cervical ripening
in patients at or near term in whom there is a medical or
obstetrical indication for the induction of labor.
CERVIDIL is designed to be released at approximately 0.3 mg/
hour over a 12-hour period. CERVIDIL should be removed upon
onset of active labor or 12 hours after insertion.
Upon removal of CERVIDIL, it is essential to ensure that
the slab has been removed as it may have separated from
the knitted polyester retrieval system and will continue
delivering the active ingredient.
IMPORTANT SAFETY INFORMATION
Contraindications
CERVIDIL is contraindicated in:
• Patients with known hypersensitivity to prostaglandins
• Patients in whom there is a clinical suspicion or definitive
evidence of fetal distress where delivery is not imminent
• Patients with unexplained vaginal bleeding during this
pregnancy
• Patients in whom there is evidence or strong suspicion of
marked cephalopelvic disproportion
• Patients in whom oxytocic drugs are contraindicated or when
prolonged contraction of the uterus may be detrimental to
fetal safety or uterine integrity, such as previous cesarean
section or uterine surgery (given the potential risk for uterine
rupture and associated obstetrical complications, including
the need for hysterectomy and the occurrence of fetal or
neonatal death)
• Patients already receiving intravenous oxytocic drugs
• Multipara with 6 or more previous term pregnancies
Warnings and Precautions
• CERVIDIL is for hospital use only and should be administered
only by trained obstetrical personnel in a hospital setting
with appropriate obstetrical care facilities.
• Use of dinoprostone may result in inadvertent disruption
and subsequent embolization of antigenic tissue causing,
in rare circumstances, the development of Anaphylactoid
Syndrome of Pregnancy (Amniotic Fluid Embolism).
• Prostaglandins, including CERVIDIL, may augment the
activity of oxytocic agents and their concomitant use is not
recommended. CERVIDIL must be removed before oxytocin
administration is initiated and a dosing interval of at least 30
minutes is recommended for the sequential use of oxytocin.
CERVIDIL is a registered trademark of Ferring B.V. © 2016 Ferring B.V. CV/807/2016/US Printed in U.S.A. April 2016
CERVIDIL IS THE1:
• FDA-approved insert for cervical ripening
• Single-dose cervical ripener
• Controlled-release formulation
• Retrievable insert with a half-life of 2.5 to
5 minutes
Giving you cervical ripening control at your
fingertips—from administration to retrieval.
See what else you need to know about CERVIDIL
at CERVIDIL.com/control
• Uterine activity, fetal status, and the progression of cervical
dilatation and effacement should be carefully monitored
whenever the CERVIDIL vaginal insert is in place. With any
evidence of uterine hyperstimulation, sustained uterine
contractions, fetal distress, or other fetal or maternal
adverse reactions, the vaginal insert should be removed.
CERVIDIL should also be removed prior to amniotomy.
• Caution should be exercised in the administration of
CERVIDIL for cervical ripening in patients with ruptured
membranes, in cases of non-vertex or non-singleton
presentation, and in patients with a history of previous
uterine hypertony, glaucoma, or a history of childhood
asthma, even though there have been no asthma attacks in
adulthood.
• Long-term carcinogenicity and fertility studies have not been
conducted with CERVIDIL. No evidence of mutagenicity has
been observed with prostaglandin E2 in the Unscheduled
DNA Synthesis Assay, the Micronucleus Test, or Ames Assay.
• Prostaglandin E2 has produced an increase in skeletal
anomalies in rats and rabbits. No effect would be expected
clinically, when used as indicated, since CERVIDIL
is administered after the period of organogenesis.
Prostaglandin E2 has been shown to be embryotoxic in rats
and rabbits, and any dose that produces sustained increased
uterine tone could put the embryo or fetus at risk.
• The safety and efficacy of CERVIDIL has been established in
women of a reproductive age and women who are pregnant.
Although safety and efficacy has not been established in
pediatric patients, safety and efficacy are expected to be the
same for adolescents.
• Women aged 30 years or older, those with complications
during pregnancy and those with a gestational age over
40 weeks have been shown to have an increased risk
of postpartum disseminated intravascular coagulation.
In addition, these factors may further increase the risk
associated with labor induction. In these women, use of
dinoprostone should be undertaken with caution. Measures
should be applied to detect as soon as possible an evolving
fibrinolysis in the immediate postpartum period. An
increased risk of postpartum disseminated intravascular
coagulation has been described in patients whose labor was
induced by physiologic means, either with dinoprostone or
oxytocin.
Adverse Reactions
• In clinical trials, the most commonly occurring adverse
reactions were uterine hyperstimulation with fetal distress
(2.8% vs 0.3% for placebo), uterine hyperstimulation without
fetal distress (4.7% vs 0%), and fetal distress without uterine
hyperstimulation (3.8% vs 1.2%).
• Drug-related fever, nausea, vomiting, diarrhea, and
abdominal pain were noted in less than 1% of patients who
received CERVIDIL.
Please see Brief Summary of full Prescribing
Information on the next page.
Reference: 1. Cervidil [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.
CERVIDIL® (dinoprostone, 10 mg) Vaginal Insert
Uterine activity, fetal status and the progression
of cervical dilatation and effacement should be
carefully monitored whenever the dinoprostone
vaginal insert is in place. With any evidence of
uterine hyperstimulation, sustained uterine
contractions, fetal distress, or other fetal or
maternal adverse reactions, the vaginal insert
should be removed.
BRIEF SUMMARY
Please consult package insert for full
Prescribing Information.
INDICATIONS AND USAGE
Cervidil Vaginal Insert (dinoprostone, 10 mg) is
indicated for the initiation and/or continuation of
cervical ripening in patients at or near term in whom
there is a medical or obstetrical indication for the
induction of labor.
Upon removal of Cervidil, it is essential to
ensure that the slab has been removed as it may
have separated from the knitted polyester
retrieval system and will continue delivering
the active ingredient.
CONTRAINDICATIONS
Cervidil is contraindicated in:
• Patients with known hypersensitivity to
prostaglandins.
• Patients in whom there is clinical suspicion or
definite evidence of fetal distress where delivery is
not imminent.
• Patients with unexplained vaginal bleeding during
this pregnancy.
• Patients in whom there is evidence or strong
suspicion of marked cephalopelvic disproportion.
• Patients in whom oxytocic drugs are contraindicated
or when prolonged contraction of the uterus may
be detrimental to fetal safety or uterine integrity,
such as previous cesarean section or major
uterine surgery (see PRECAUTIONS and
ADVERSE REACTIONS).
• Patients already receiving intravenous
oxytocic drugs.
• Multipara with 6 or more previous term pregnancies.
WARNINGS
For hospital use only
Cervidil should be administered only by trained
obstetrical personnel in a hospital setting with
appropriate obstetrical care facilities.
Women aged 30 years or older, those with
complications during pregnancy and those with a
gestational age over 40 weeks have been shown to
have an increased risk of postpartum disseminated
intravascular coagulation. In addition, these factors
may further increase the risk associated with
labor induction (See ADVERSE REACTIONS,
Post-marketing surveillance). Therefore, in these
women, use of dinoprostone should be undertaken
with caution. Measures should be applied to detect
as soon as possible an evolving fibrinolysis in the
immediate post-partum period.
The Clinician should be alert that use of
dinoprostone may result in inadvertent disruption
and subsequent embolization of antigenic tissue
causing in rare circumstances the development of
Anaphylactoid Syndrome of Pregnancy (Amniotic
Fluid Embolism).
An increased risk of post-partum disseminated
intravascular coagulation has been described in
patients whose labor was induced by physiologic
means, either with dinoprostone or oxytocin.
2. Drug Interactions: Cervidil may augment the
activity of oxytocic agents and their concomitant
use is not recommended. A dosing interval of
at least 30 minutes is recommended for the
sequential use of oxytocin following the removal
of the dinoprostone vaginal insert. No other drug
interactions have been identified.
3. Carcinogenesis, Mutagenesis, Impairment of
Fertility: Long-term carcinogenicity and fertility
studies have not been conducted with Cervidil
(dinoprostone) Vaginal Insert. No evidence of
mutagenicity has been observed with
prostaglandin E2 in the Unscheduled DNA
Synthesis Assay, the Micronucleus Test, or
Ames Assay.
In study 101-801 (with the retrieval system) cases of
hyperstimulation reversed within 2 to 13 minutes of
removal of the product. Tocolytics were required in
one of the five cases.
In cases of fetal distress, when product removal
was thought advisable there was a return to normal
rhythm and no neonatal sequelae.
Five minute Apgar scores were 7 or above in
98.2% (646/658) of studied neonates whose
mothers received Cervidil. In a report of a 3 year
pediatric follow-up study in 121 infants, 51 of
whose mothers received Cervidil, there were
no deleterious effects on physical examination or
psychomotor evaluation (18).
Post-marketing surveillance
Immune System Disorders: Hypersensitivity
Blood and lymphatic system disorders:
Disseminated Intravascular Coagulation
(See WARNINGS Section)
Reproductive system: Reports of uterine rupture
have been reported in association with use of
Cervidil some required a hysterectomy and some
resulted in subsequent fetal or neonatal death.
4. Pregnancy, Teratogenic Effects: Prostaglandin E2
has produced an increase in skeletal anomalies
in rats and rabbits. No effect would be expected
clinically, when used as indicated, since Cervidil
(dinoprostone) Vaginal Insert is administered after
the period of organogenesis. Prostaglandin E2 has
been shown to be embryotoxic in rats and rabbits,
and any dose that produces sustained increased
uterine tone could put the embryo or fetus at risk.
Vascular Disorders: Hypotension
5. Pediatric Use: The safety and efficacy of Cervidil
has been established in women of a reproductive
age and women who are pregnant. Although
safety and efficacy has not been established in
pediatric patients, safety and efficacy are expected
to be the same for adolescents.
Cervidil is used as a single dosage in a single
application. Overdosage is usually manifested
by uterine hyperstimulation which may be
accompanied by fetal distress, and is usually
responsive to removal of the insert. Other
treatment must be symptomatic since, to date,
clinical experience with prostaglandin antagonists
is insufficient.
ADVERSE REACTIONS
Cervidil is well tolerated. In placebo-controlled trials
in which 658 women were entered and 320 received
active therapy (218 without retrieval system, 102
with retrieval system), the following events
were reported.
Table 1
Total Cervidil – Treated
Drug-Related Adverse Events
Controlled
Studies1
PRECAUTIONS
1. General Precautions: Since prostaglandins
potentiate the effect of oxytocin, Cervidil must
be removed before oxytocin administration
is initiated and the patient’s uterine activity
carefully monitored for uterine hyperstimulation.
If uterine hyperstimulation is encountered or if
labor commences, the vaginal insert should be
removed. Cervidil should also be removed prior to
amniotomy.
Active
Placebo
Uterine hyperstimulation
with fetal distress
2.8%
0.3%
Uterine hyperstimulation
without fetal distress
4.7%
0%
Fetal Distress without
uterine hyperstimulation
3.8%
1.2%
320
338
N
STUDY 101-8012
Cervidil is contraindicated when prolonged
contraction of the uterus may be detrimental to
fetal safety and uterine integrity. Therefore,
Cervidil should not be administered to patients
with a history of previous cesarean section or
uterine surgery given the potential risk for uterine
rupture and associated obstetrical complications,
including the need for hysterectomy and the
occurrence of fetal or neonatal death.
Caution should be exercised in the administration
of Cervidil for cervical ripening in patients with
ruptured membranes, in cases of non-vertex or
non-singleton presentation, and in patients with
a history of previous uterine hypertony, glaucoma,
or a history of childhood asthma, even though
there have been no asthma attacks in adulthood.
Drug related fever, nausea, vomiting, diarrhea,
and abdominal pain were noted in less than 1% of
patients who received Cervidil.
Active
Placebo
Uterine hyperstimulation
with fetal distress
2.9%
0%
Uterine hyperstimulation
without fetal distress
2.0%
0%
Fetal Distress without
uterine hyperstimulation
2.9%
1.0%
102
104
N
1
Controlled Studies (with and without retrieval system)
Controlled Study (with retrieval system)
2
Pregnancy, Puerperium and Perinatal Conditions:
Amniotic fluid embolism
To report SUSPECTED ADVERSE REACTIONS,
contact FERRING PHARMACEUTICALS INC. at
1-888-FERRING (1-888-337-7464) or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
OVERDOSAGE
The use of beta-adrenergic agents should be
considered in the event of undesirable increased
uterine activity.
For more information, go to www.CERVIDIL.com
or call 1-888-FERRING (1-888-337-7464).
MANUFACTURED IN SCOTLAND
MANUFACTURED FOR:
FERRING PHARMACEUTICALS INC.
PARSIPPANY, NJ 07054
Rev. 02/16 6870-03
CV/1178/2016/US
CESAREAN RATES
READERS REACT
CONTINUED FROM PAGE 11
IN REPLY:
The clinicians who wrote in make
great, relevant points. As a clinician
first, and researcher/educator/administrator second, I am always interested
in the viewpoints of busy clinicians. Dr
Zalar makes the point that the journal
should convene a best practices panel.
The ACOG/SMFM/NICHD document
that we published in spring of 2014 was
just that—the efforts from a collection
of clinicians from around the country,
vetted by the existing evidence, and
winnowed down to those interventions that we thought would make the
biggest difference. But I would agree
that is just the starting point. If each
institution convened such a panel for
internal review, it would make a big
difference. Five years ago, we started
reviewing all cesareans at my institution and discussing why they occurred, and in just a few months, there
was a rapid reduction in cesarean rates
from 34% to 25%.
The second letter mentions the
use of forceps, which I am sad to say,
has continued to wane in the United
States. I have trained residents to use
the obstetric forceps for the past 17
years and even last year after one of
our residents joined our faculty, she
texted me after her first night on call
to tell me that they had done 2 forceps deliveries overnight. We are not
a high-volume program, but remain
dedicated to training our residents to
perform forceps deliveries. The forceps, in my opinion, are a more effec-
MOST WOMEN WE CARE
FOR ARE EXPERIENCING
A NORMAL PHYSIOLOGIC
PROCESS, NOT
PATHOLOGY.
tive and safer approach to the operative vaginal delivery than the vacuum
and I believe that all it takes to ensure
safe training of our residents is a faculty commitment to include trainees
in forceps deliveries. In fact, with improved simulation equipment, I believe that forceps training is easier and
safer than ever and should be strongly
encouraged nationwide.
Dr Skulemowski comments that
there is no economic incentive to do
VBACs. This is absolutely true. In fact,
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there is really no incentive to do vaginal deliveries at all. The cesarean delivery is almost always quicker from
the clinician perspective, less intrusive in a busy schedule, usually reimburses at a higher rate, and reduces
litigation exposure. But, while VBAC
rates have reduced and cesarean rates
have increased, the majority of deliveries are still vaginal. Thus, many clinicians are still practicing thoughtful,
evidence-based medicine, trying to
do the right thing for the women they
care for, much like the letter writer. As
a society, could we do better? Yes, we
could properly reimburse and incentivize clinicians to achieve higher vaginal delivery rates. During labor, one
of the principle activities is ongoing
fetal assessment. Somehow this activity of frequent fetal assessment has
been rolled up into the global charge
for a delivery. Yes, with a prolonged
labor, this might mean hours of work,
whereas for a scheduled cesarean, it
could be a single nonstress test (NST).
Clinicians should be able to bill for the
hourly NSTs or contraction stress tests
being performed.
In the end, the large majority of
women we care for on labor and delivery are experiencing a normal physiologic process, not pathology. Thus,
what they need is support, pain relief, and ongoing vigilance to ensure
that complications are prevented or
managed to minimize harm. The cesarean delivery is a remarkable tool
of the twentieth century that can and
has saved countless lives. However,
we need to use it judiciously so that it
does not cost more lives than it saves.
Aaron B Caughey, MD, PhD
The editors reserve the right to shorten or edit letters and comments.
JUNE 2016
CONTEMPOR ARY OB/GYN
15
PEER-REVIEWED
OBESITY
Maternal obesity
and the fetal brain
The problems go beyond fetal metabolic programming. Obesity
has effects on fetal neurodevelopment.
by ANDREA G EDLOW, MD, MSC, AND LARISSA H MATTEI, BA
I
n the United States, more
than 60% of reproductive-age
women are overweight and
35% are obese, representing a
70% increase in pre-pregnancy obesity.1,2 Childhood obesity and
early-onset metabolic syndrome have
risen in parallel.1-3 While it is now
relatively well-known that maternal
obesity, maternal high-fat diet, and
high gestational weight gain (GWG)
may have harmful effects on fetal and
offspring metabolic programming,
awareness of the potential harmful programming effects on the fetal
brain is less widespread.
The effect of maternal obesity, highfat diet, and GWG on fetal neurodevelopment and offspring behavior is the
focus of this review.
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Evidence from epidemiologic studies
Compelling data from large epidemiologic studies have demonstrated
an association between maternal
obesity and a variety of neurodevelopmental morbidities in offspring.
All relationships, odds ratios, relative
risks, and IQ decrements reported
here achieved statistical significance
in the referenced studies, unless otherwise indicated.
Increased odds of cognitive deficits, decreased IQ, and intellectual
disability
Maternal obesity may increase the
risk for intellectual disability or cognitive deficits in offspring from 1.3- to
3.6-fold.4-7 Maternal obesity has been
linked to decrements in offspring
cognition (eg, 2–5 points lower IQ in
offspring of obese women compared
to non-obese counterparts),4,8,9 with
every increase of 1 unit in maternal
prepregnancy BMI found to be asso-
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MS MATTEI is a fourth-year medical student at Tufts
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University School of Medicine, Boston, Massachusetts.
Tufts Medical Center, Boston, Massachusetts, and an
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Tufts Medical Center, Boston.
16
CONTEMPOR ARYOBGYN.NE T
JUNE 2016
OBESITY
ciated with a significant reduction in
offspring IQ and non-verbal IQ, suggesting a dose-response relationship.8
High GWG seems to augment this association.4 Maternal pre-pregnancy
obesity pls GWG of > 40 lb was associated with a 3-fold increase in offspring
IQ deficit (mean of 6.5 points lower).4
Of note, extremely low maternal prepregnancy BMI (<18.5 kg/m2) has also
been significantly associated with lower offspring IQ, although the reported
decrement is less than in the setting of
maternal obesity.4,6
Increased odds of autism
spectrum disorders (ASD)
The majority of studies that have examined a link between high maternal
BMI and childhood diagnosis of ASD
have found a significant positive association.10-13 This risk may be further
augmented by intrauterine growth
restriction (IUGR),14 preterm birth,12
high GWG,13 gestational or pre-gestational diabetes,10,11 and preeclampsia.15
Two recent studies including
matched sibling analyses failed to
find a significant relationship between
maternal pre-pregnancy BMI and ASD
risk,16,17 suggesting that maternal BMI
might be a proxy marker for other familial risk factors conferring an increased risk of ASD in offspring. High
GWG was independently associated
with offspring ASD risk, even in studies that failed to find an association
with maternal pre-pregnancy obesity.16,17 Of note, paternal obesity has
also been demonstrated to be independently associated with increased
ASD risk in offspring.18
Increased odds of attention deficit
hyperactivity disorder (ADHD)
A dose-dependent increase in ADHD
JUNE 2016
MATERNAL OBESITY MAY
INCREASE THE RISK FOR
INTELLECTUAL DISABILITY
OR COGNITIVE DEFICITS
IN OFFSPRING FROM
1.3-FOLD
3.6-FOLD
TO
symptoms in children was noted in
Swedish, Danish, and Finnish pregnancy cohorts as maternal pre-pregnancy BMI increased from overweight
to obese.19 Later studies confirmed this
association with up to a 2.8-fold increased risk of offspring ADHD compared to non-obese counterparts.20-22
A recent study found that the association between maternal obesity and
increased risk of ADHD in offspring
was true for white but not black women.23 Another study failed to find an
association between maternal obesity
and offspring ADHD after adjusting for
confounders such as socioeconomic
status.24 Still, the preponderance of
epidemiologic evidence suggests that
maternal obesity is associated with
ADHD risk in offspring.
Increased odds of cerebral
palsy (CP)
A dose-dependent increase in offspring CP risk has been noted as maternal BMI increases from overweight
to morbidly obese (from 1.2 to 3.0
times increased odds).25-28 One study
reported that each unit increase in
maternal BMI raised the risk of CP by
PEER-REVIEWED
7%, and each kg of additional weight
at 34 weeks increased the risk of CP by
2%.25 While underlying mechanisms
have not been fully elucidated, some
have postulated that maternal inflammation may be causative, as obesity
induces a chronic inflammatory state,
and other maternal inflammatory
conditions such as chorioamnionitis
are known to confer an increased risk
for CP.26,29
Limitations of existing
epidemiologic data
The aforementioned studies defined
maternal pre-pregnancy obesity as a
reported pre-pregnancy or measured
early pregnancy BMI ≥30 kg/m2 or absolute pregnancy weight >90 kg. These
definitions do not identify percent of
weight due to body fat and/or the distribution of body fat, both of which
may have bearing on maternal and fetal health.27,30
Epidemiological studies are also
limited by their inability to demonstrate causation or to elucidate mechanism; the fact that some of these data
are from large US or European population-level studies in the 1970s–1990s,
when obesity was less prevalent; and
the fact that many of these studies suffer from attrition, sampling biases for
control groups, reliance on parental
report to evaluate past exposure and
offspring diagnosis, lack of statistical power, and inability to adjust for
confounders.31
Physiology of obese
pregnancy
The primary mechanisms that have
been proposed to underlie the risk of
neurodevelopmental morbidity in offspring of obese women include:
1) I n f l a m m a t i o n - i n d u c e d
CONTEMPOR ARY OB/GYN
17
PEER-REVIEWED
malprogramming
2) Relative excess and/or deficiencies of circulating nutrients
3) Metabolic hormone-induced
malprogramming, and
4) Impaired development of serotonergic and dopaminergic
signaling
These mechanisms are not necessarily distinct from one another, and
feature several interconnections (Figure). A brief summary of the evidence
in these areas follows.
Inflammation-induced
malprogramming
Both maternal obesity and pregnancy
itself are associated with chronic systemic inflammation.32 Obese women
have been demonstrated to have exaggerated physiologic responses to
pregnancy, with increased circulating
levels of pro-inflammatory cytokines
compared to their normal weight
counterparts.33-35 Maternal BMI has
been shown to be directly correlated
with maternal blood concentrations
of cytokines and with activation of
pro-inflammatory pathways in the
placenta.33,36
Placental and intrauterine inflammation are associated with altered
fetal cytokine expression, fetal neuronal damage, and changes in neonatal
brain gene expression.35,37 Elevated
levels of maternal pro-inflammatory
cytokines during gestation have been
linked to an increased risk for ASD and
neurodevelopmental delay in children.38 Children with ASD have also
been shown to have elevated plasma
markers of inflammation.39,40
It is postulated that underlying maternal and placental inflammation in
the setting of maternal obesity plays
a key role in fetal brain inflammation
18
CONTEMPOR ARYOBGYN.NE T
OBESITY
and subsequent abnormal offspring
neurodevelopment.27,35 This concept
has been corroborated by animal studies. Rat offspring exposed to maternal
obesity and a high-fat diet in utero
demonstrated increased neuronal and
systemic inflammation, poor memory
retention, and changes in anxiety levels and spatial reasoning.27,41,42
implicated in abnormal neurodevelopment of the fetus.27
Obese pregnant women were also
found to have lower levels of nutritional antioxidants, suggesting that fetuses
of obese women may be exposed to
more oxidative stress and inflammation than those of lean women.47
FETUSES OF OBESE WOMEN MAY BE EXPOSED TO MORE
OXIDATIVE STRESS AND INFLAMMATION THAN
FETUSES OF LEAN WOMEN.
Rodent and non-human primate
models of maternal obesity and highfat diet in pregnancy have demonstrated increased brain inflammation,
decreased sociability, increased hyperactivity, and impaired hippocampal learning in offspring.42-44 A murine model of maternal inflammation
demonstrated deficits in offspring social behavior, and highlighted a critical
role for the cytokine interleukin-6 in
mediating these behavioral changes.45
Relative excess or deficiency of
circulating nutrients
Maternal obesity is associated with increased circulating free fatty acids and
glucose, due to diet, increased insulin
resistance, and increased adipose tissue lipolysis.27,31,46 The fetus is exposed
to an excess of certain circulating nutrients. Obesity has also been shown to
coexist with states of subclinical malnutrition characterized by excess energy intake with a relative deficiency
in circulating micronutrients.27 Excess
free fatty acids and glucose in maternal circulation and deficiencies of vitamin D, B12, folate, and iron have been
Metabolic hormone-induced
malprogramming
Fetuses of obese women may be
chronically exposed to insulin resistance and a glucose-rich environment,
even in the absence of diagnosed gestational or pre-gestational diabetes.48
The fetal pancreas compensates by
producing increased insulin, and the
pro-inflammatory environment compounds fetal insulin resistance via inflammatory changes in fetal adipose
tissue.49 Insulin acts on the fetal brain
as a growth factor, and excess insulin exposure can cause disruptions in
neural circuitry, brain development,
and behavior.48 Maternal hyperinsulinemia in the setting of Type 2 diabetes and gestational diabetes have been
shown to be associated with increased
risk of ASD and neurodevelopmental
delay.50
Leptin levels are also elevated in
obese mothers.50,51 Leptin functions
as a critical neurotrophic factor, and
leptin signaling abnormalities during
fetal development have been associated with decreased neuronal stem cell
differentiation and growth.52 Leptin re-
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PEER-REVIEWED
OBESITY
ceptors are widely distributed in brain
regions involved in behavioral regulation,53 so derangement in leptin signaling during key developmental pe-
riods is another potential mechanism
underlying abnormal neurodevelopment in fetuses of obese women.13
Impaired development of serotonergic and dopaminergic signaling
Maternal obesity may also increase
the risk of neurodevelopmental and
FIGURE. MECHANISMS UNDERLYING INTRAUTERINE MALPROGRAMMING
AND OFFSPRING MORBIDITY IN MATERNAL OBESITY
Maternal obesity
and gestational
weight gain
Changes in placenta
and intrauterine
environment
Altered maternal
physiology
Fetal
malprogramming
Fetal brain
Placenta
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20
CONTEMPOR ARYOBGYN.NE T
JUNE 2016
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PEER-REVIEWED
psychiatric disorders through abnormal development of the serotonergic
(5-hydroxytryptamine or 5-HT) and
dopaminergic (DA) systems. 5-HT signaling plays a significant role in neuronal migration, cortical neurogenesis,
and synaptogenesis during fetal brain
development.50,54 In murine and nonhuman primate models, offspring exposed to maternal high-fat diet had decreased 5-HT synthesis, and increased
anxiety behavior, hyperactivity, and
hypothalamic inflammation.31,48
Subclinical inflammation in maternal obesity may also decrease 5-HT
production in offspring through increased breakdown of the 5-HT precursor tryptophan.50 In rodent models, pro-inflammatory cytokines have
been demonstrated to reduce 5-HT
neuron axonal density and embryonic neuronal survival in brain regions
critical for behavioral regulation.55,56
Suppressed 5-HT synthesis has been
observed in humans with ADHD, ASD,
anxiety, and depression.31,48 Thus, altered 5-HT production may be one
mechanism by which maternal obesity
increases risk for neurodevelopmental
disorders in offspring.
The dopaminergic system mediates
reward neural circuitry and is similarly
affected by maternal obesity. Rat offspring exposed to high-fat diets in utero had impaired mesolimbic dopaminergic signaling, resulting in impaired
stress response and reward response
to food.57,58 In mice, a maternal highfat diet caused epigenetic changes in
offspring DNA leading to dopamine
dysregulation and changes in food
preferences.59
Offspring changes in dopaminergic signaling may again be mediated
through maternal inflammation; in a
rat model of maternal inflammation,
22
CONTEMPOR ARYOBGYN.NE T
OBESITY
dopamine circuitry in offspring was
dysregulated.60 Impaired dopaminergic signaling has been implicated in
the development of ASD, ADHD, disordered eating, and other psychiatric
disorders in humans.48
ga-3 fatty acids have demonstrated
reduction in maternal and placental
inflammation.64 An ongoing clinical
trial in obese pregnant women employs BMI-based prenatal micronutrient supplementation, with the goal of
decreasing maternal and fetal oxida-
OBSERVATIONAL DATA HAVE POINTED TO OMEGA-3 AND
OMEGA-6 FATTY ACIDS AS POSSIBLE CANDIDATE THERAPEUTICS
IN MATERNAL OBESITY.
Exploratory therapies
Maternal lifestyle and dietary changes, metformin treatment, and nutrient supplementation have all been
explored as interventions to improve
offspring neurodevelopment in maternal obesity.61-66 In animal studies,
prepregnancy and lactational change
from a high-fat diet to a control diet reduced offspring adiposity, circulating
leptin, and anxiety behaviors.61 In a rat
model of diet-induced obesity, maternal metformin treatment reduced
fetal and placental inflammation.62
Observational data have pointed to
polyunsaturated fatty acids, including omega-3 and omega-6 fatty acids,
as possible candidate therapeutics in
maternal obesity. Omega-3 fatty acids
protect against brain inflammation
and enhance serotonin signaling.31
Maternal omega-3 fatty acid deficiency has been associated with increased
risk of offspring ASD and ADHD.63
A retrospective analysis of data from
the Nurses’ Health Study II suggested
that maternal intake of high levels of
omega-6 fatty acids was associated
with a 34% reduction in offspring ASD
risk.65 Human pilot studies of obese
maternal supplementation with ome-
tive stress and inflammation.66
Applications to patient care
r 1SFDPODFQUJPO DPVOTFMJOH PG
obese and overweight women may be
appropriate to discuss risks and to encourage weight loss and adoption of a
healthy diet prior to pregnancy.
r .BUFSOBM QSFDPODFQUJPO MJGFTUZMF
change and weight loss may also reduce the risk for preeclampsia and
gestational/pregestational diabetes,
which have also been associated with
iatrogenic prematurity and an increased risk for ASD and other neurodevelopmental morbidity in offspring.
r&WJEFODFJTJOTVŁDJFOUUPSFDPNmend routine omega-3 or omega-6
fatty acid supplementation in obese
pregnant women to reduce the risk
of offspring neurodevelopmental
morbidity.
r&WJEFODFJTJOTVŁDJFOUUPSFDPNmend routine use of metformin in
obese pregnant women to reduce the
risk of offspring neurodevelopmental
morbidity. FOR REFERENCES VISIT
contemporaryobgyn.net/obesity-fetal-brain
JUNE 2016
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PB-2005117 rev A
PEER-REVIEWED
OBESITY
Morbidly obese
gravidas: Labor or not?
Vaginal delivery is the least morbid, but a trial of labor after cesarean
is not always successful.
by RODNEY K EDWARDS, MD, MS
Y
ou are covering the Labor and Delivery unit
when a patient presents for a scheduled induction of labor. She is
a 35-year-old African-American P1001
at 40 weeks gestational age who had a
prior cesarean delivery (CD) due to arrest of dilation at 8 cm. She is 5 ft 3 in
tall and weighs 280 lb (body mass index [BMI] 50 kg/m2).
Her pregnancy has been uncomplicated, and the estimated fetal weight is
4000 g. Is trial of labor after cesarean
(TOLAC) in this patient’s best interest? What if she were nulliparous and,
therefore, did not have a history of a
prior cesarean delivery?
TOLAC in the general
population
Prior to the 1980s, because labor after
a previous cesarean delivery was be-
Morbidly obese women who have had a prior cesarean and wish to
QUICK
TAKE
have a trial of labor (TOLAC) face increased risks if the trial fails.
The iikelihood of morbidity with TOLAC is inversely proportional to the
likelihood of a successful vaginal delivery.
lieved to be dangerous, many obstetricians recommended repeat cesareans
for all subsequent births to women
with a previous such delivery. Since
then, TOLAC has been advocated as a
reasonable alternative for women with
a previous cesarean delivery via a low
transverse uterine incision. Practice
Bulletin No. 115 from the American
College of Obstetricians and Gynecologists (ACOG) states that “ … a failed
labor … compared with vaginal birth
after cesarean (VBAC), is associated
with increased maternal and perinatal morbidity. Assessment of individual risks and the likelihood of VBAC is,
therefore, important in determining
who are appropriate candidates for
TOLAC.”1
The statement is purposefully vague
in order to define a range in standard
of care, but what degree of risk is tolerable and what likelihood of VBAC success is needed for a patient to be an
“appropriate candidate” for TOLAC?
Twenty years ago, McMahon and
colleagues published a populationbased, longitudinal study of 6138
women in Nova Scotia who had a
single prior cesarean delivery and delivered a live singleton infant during
the study period. The overall rate of
DR EDWARDS is Professor and Chief, Section of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology,
8QLYHUVLW\RI2NODKRPD+HDOWK6FLHQFHV&HQWHU2NODKRPD&LW\+HKDVQRFRQÁLFWRILQWHUHVWWRUHSRUWLQUHVSHFWWRWKH
content of this article.
24
CONTEMPOR ARYOBGYN.NE T
JUNE 2016
OBESITY
TOLAC
RCD
VBAC
RCD
RCD
Fewest
complications
Most
complications
Intermediate
likelihood of
complications
FIGURE 1 Many women with a previous cesarean delivery may choose between
TOLAC and RCD without labor. TOLAC may result in a VBAC, the delivery
outcome with the lowest risk of complications, or an RCD after failed labor, the
delivery outcome with the highest risk of complications. Women who undergo
RCD without labor have a risk of complications that falls between the other 2
groups. Abbreviations: RCD, repeat cesarean delivery; TOLAC, trial of labor
after cesarean; VBAC, vaginal birth after cesarean
maternal complications did not differ significantly between women who
attempted TOLAC (considering collectively both women having a VBAC
and those requiring a repeat cesarean
delivery after failed TOLAC) and those
who elected a repeat cesarean delivery without labor. However, major
complications (hysterectomy, uterine
rupture, and/or operative injury) were
almost twice as likely in the group who
attempted TOLAC (again, considering collectively both women having
a VBAC and those requiring a repeat
cesarean delivery after failed TOLAC)
(adjusted odds ratio [aOR] 1.8, 95%
confidence interval [CI] 1.1–3.0).2 This difference was driven by the
fact that major complications were 5
times as likely with failed TOLAC attempts compared to successful ones
(aOR 5.1, 95% CI 2.8–9.4). Patients
electing repeat cesarean delivery
JUNE 2016
without labor had rates of major complications intermediate between the
successful and unsuccessful TOLAC
groups (Figure 1).2
Data from this and other studies
contributed to the waning enthusiasm for VBAC in the United States—
the rate of VBAC in 1996 was 28%; it
has been <12% every year since 2004.3
Because the likelihood of morbidity
with TOLAC is inversely proportional
to the likelihood of success (ie, vaginal
delivery), it is helpful, when counseling patients about TOLAC versus repeat cesarean delivery without labor,
to consider a woman’s individual likelihood of TOLAC success. A useful
calculator is available from the Eunice
Kennedy Shriver National Institute of
Child Health and Human Development Maternal-Fetal Medicine Units
(MFMU) Network at https://mfmu.
bsc.gwu.edu/PublicBSC/MFMU/VG-
PEER-REVIEWED
BirthCalc/vagbirth.html. This calculator takes into account the patient’s age,
BMI, race/ethnicity, number of prior
vaginal deliveries, and primary indication for previous cesarean delivery.4
TOLAC in morbidly obese
women
Multiple studies have reported that
morbid obesity is a risk factor for
failed TOLAC. Using an unconventional definition of >300 lb at the first
prenatal care visit, Chauhan et al. reported a VBAC success rate of only
13% in morbidly obese women and
recommended repeat cesarean delivery without labor in such patients.5,6
Using a more conventional definition
of morbid obesity (BMI ≥40 kg/m2 at
the first prenatal visit), Edwards et al.
reported a VBAC success rate of 57%.
However, despite success among
most patients who attempted TOLAC,
puerperal infections were 3 times as
likely in the TOLAC group compared
to the elective repeat cesarean delivery
group, and there was no cost benefit to
TOLAC compared with elective repeat
cesarean delivery.7
Hibbard et al. reported that, in
women with a BMI ≥40, composite
maternal morbidity (OR 1.9; 95% CI
1.5–2.6) and neonatal injury (OR 5.1;
95% CI 1.9–13.8) are more likely with
TOLAC compared to elective repeat
cesarean delivery.8 Similar to the data
from McMahon and colleagues from
the general population, the highest
risk of morbidity was with failed TOLAC, highlighting the need to undertake TOLAC only if a patient has a reasonably high likelihood of success.
Of note, according to the MFMU
VBAC calculator, the patient in the
case at the beginning of this article
would have a 12.8% likelihood of de-
CONTEMPOR ARY OB/GYN
25
PEER-REVIEWED
livering vaginally.
The morbidly obese woman
without a prior cesarean
delivery
We know that morbid obesity is associated with an increased risk of labor
induction, induction failure, and
cesarean delivery.9-14 Because these
outcomes are increased, obesity also
is associated with increased risks of
clinical chorioamnionitis, postpartum hemorrhage, wound infections,
surgical complications, and increased
neonatal morbidity (Figure 2).10,15-17
In addition, even lesser degrees of
obesity (BMI 30–39) have been independently associated with postterm
pregnancy, induction of labor, and
cesarean delivery after postterm labor
inductions.18-22
A randomized controlled trial
would be the ideal study for comparing planned cesarean delivery to induction of labor for morbidly obese
women who do not spontaneously labor. However, the feasibility of such a
study is questionable at best.
Data from recent studies
Subramaniam et al. recently published
a cohort study evaluating women with
singleton pregnancies, a BMI ≥40, and
delivery via either cesarean without labor or after labor induction. Sixty-five
percent of the induction group had
cervical ripening, and the cesarean delivery rate in the induction group was
41%. A composite of maternal morbidities occurred in 18.2% of the women
who delivered vaginally after labor induction, 45.4% of those who had a cesarean delivery after an unsuccessful
labor induction, and 24.4% who had a
planned cesarean delivery without labor. After multivariable adjustments,
26
CONTEMPOR ARYOBGYN.NE T
OBESITY
maternal morbidity (aOR 0.98; 95% CI
0.55–1.77) was similar in women delivered by planned cesarean compared
to the overall group delivered after inductions (both patients who delivered
vaginally and those having a cesarean
delivery after a failed induction).23
Neonatal morbidity followed a similar pattern—the neonatal morbidity composite occurred in 8.1% of the
women who delivered vaginally after
labor induction, 20.9% of those who
had a cesarean delivery after an unsuccessful labor induction, and 10.3%
who had a planned cesarean delivery
without labor.
After multivariable adjustments,
neonatal morbidity (aOR 0.81; 95%
CI 0.37–1.77) was similar in women
delivered by planned cesarean delivery compared to the overall group
delivered after labor inductions (both
patients who delivered vaginally and
those having a cesarean delivery after
a failed induction).23 As expected, the
group with the highest risks of both
maternal and neonatal morbidity were
patients who underwent cesarean delivery after an unsuccessful labor induction (aOR 3.7; 95% CI 2.4–5.9 for
maternal and aOR 3.0; 95% CI 1.6–5.5
for neonatal morbidity).
Using the same dataset, a cost minimization analysis showed that induction of labor in such patients is less
costly than cesarean delivery without
labor only if the chance of vaginal delivery is >57% (a cesarean delivery rate
of <43%).24 Many subgroups of obese
women have cesarean delivery rates
in excess of 43%. Gunatilake et al. reported a 78% rate of cesarean delivery
in women with a BMI ≥60.25 In a RCT
of cervical ripening methods, Edwards
et al. reported a 55% rate of cesarean
delivery in women with a BMI ≥40 who
Obesity
Increased risks of:
Labor induction
Induction failure
Cesarean delivery
Increased risks of:
Clinical chorioamnionitis
Postpartum hemorrhage
Wound infections
Surgical complications
Neonatal morbidity
FIGURE 2 Labor induction, failure
of labor induction, and cesarean
delivery lead to increased rates of
complications for the mother, fetus,
and newborn.
started labor inductions with the dinoprostone insert.26
More tools needed
Previous cesarean delivery is a risk
factor for placenta previa, placenta
accreta, and hysterectomy in future
pregnancies. Due to the fact that these
complications are associated with previous cesarean delivery, the patient’s
plans for future pregnancy should
be considered when making decisions about delivery route. However,
these complications are far less likely than the complications that drove
the maternal morbidity composite
in the above study by Subramaniam
et al (puerperal infection, wound infection and/or disruption, postpartum hemorrhage, and hysterotomy
extension).23
Until current trends reverse, clini-
JUNE 2016
OBESITY
cians will increasingly be faced with
counseling morbidly obese women
regarding their planned mode of delivery. In terms of morbidity risk, vaginal
delivery is the preferred outcome for
these women. However, cesarean delivery after labor is more morbid than
cesarean delivery without labor.
Providers need a calculator similar
to the MFMU VBAC calculator that is
capable of assigning a likelihood of
vaginal delivery for morbidly obese
women undergoing induction of labor. If the chance of vaginal delivery
was sufficiently low using such a calculator, a primary cesarean delivery
without a labor attempt would be less
costly and would pose less risk to both
mother and child.
Development of such a calculator
and evaluation of outcomes when
patient care is guided by the results
should be a research priority. REFERENCES
1. Vaginal birth after previous cesarean delivery. Practice Bulletin No. 115. American
College of Obstetricians and Gynecologists.
Obstet Gynecol. 2010;116:450-463.
2. McMahon MJ, Luther ER, Bowes WA, et
al. Comparison of a trial of labor with an elective second cesarean section. N Engl J Med.
1996;335:689-695.
3. Hamilton BE, Martin JA, Osterman MJK,
et al. Births: Final data for 2014. National vital statistics reports; vol 64 no 12. Hyattsville,
MD: National Center for Health Statistics.
2015.
4. Grobman WA, Lai Y, Landon MB, et al. Development of a nomogram for prediction of
vaginal birth after cesarean delivery. Obstet
Gynecol. 2007;109:806-812.
5. Chauhan SP, Magann EF, Carroll CS, Barrilleaux PS, Scardo JA, Martin JN. Mode of
delivery for the morbidly obese with prior
cesarean delivery: vaginal versus repeat
cesarean section. Am J Obstet Gynecol.
JUNE 2016
2001;185:349-354.
6. Carroll CS, Magann EF, Chauhan SP, Klaser
CK, Morrison JC. Vaginal birth after cesarean
section versus elective repeat cesarean delivery: weight-based outcomes. Am J Obstet
Gynecol. 2003;188:1516-1522.
7. Edwards RK, Harnsberger DS, Johnson IM,
Treloar RW, Cruz AC. Deciding on route of delivery for obese women with a prior cesarean.
Am J Obstet Gynecol. 2003;189:385-390.
8. Hibbard JU, Gilbert S, Landon MB, et al. Trial of labor or repeat cesarean delivery in women with morbid obesity and previous cesarean
delivery. Obstet Gynecol. 2006;108:125-133.
9. Baeten JM, Bukusi EA, Lambe M. Pregnancy complications and outcomes among
overweight and obese nulliparous women.
Am J Public Health. 2001;91:436-440.
10. Cedergren MI. Maternal morbid obesity
and the risk of adverse pregnancy outcome.
Obstet Gynecol. 2004;103:219-224.
11. Sebire NJ, Jolly M, Harris JP, et al. Maternal obesity and pregnancy outcome: a study
of 287,213 pregnancies in London. Int J Obes
Relat Metab Disord. 2001;25:1175-1182.
12. Weiss JL, Malone FD, Emig D, et al. Obesity, obstetric complications and cesarean
delivery rate – a population-based screening
study. FASTER Research Consortium. Am J
Obstet Gynecol. 2004; 190:1091-1097.
13. Wolfe KB, Rossi RA, Warshak CR. The effect of maternal obesity on the rate of failed
induction of labor. Am J Obstet Gynecol.
2011;205:128.e1-7.
14. Pevzner L, Powers BL, Rayburn WF, Rumney P, Wing DA. Effects of maternal obesity
on duration and outcomes of prostaglandin
cervical ripening and labor induction. Obstet
Gynecol. 2009;114:1315-1321.
15. Scott-Pillai R, Spence D, Cardwell CR,
Hunter A, Holmes VA. The impact of body
mass index on maternal and neonatal outcomes: a retrospective study in a UK obstetric population, 2004-2011. BJOG.
2013;120:932-939.
16. Vermillion ST, Lamoutte C, Soper DE,
Verdeja A. Wound infection after cesarean:
PEER-REVIEWED
effect of subcutaneous tissue thickness. Obstet Gynecol. 2000;95:923–926.
17. Owen J, Andrews WW. Wound complications after cesarean sections. Clin Obstet Gynecol. 1994;37:842–855.
18. Roos N, Sahlin L, Ekman-Ordeberg G,
Kieler H, Stephansson O. Maternal risk factors for postterm pregnancy and cesarean
delivery following labor induction. Acta Obstet
Gynecol Scand. 2010; 89:1003-1010.
19. Athukorala C, Rumbold AR, Willson
KJ, Crowther CA. The risk of adverse pregnancy outcomes in women who are overweight or obese. BMC Pregnancy Childbirth.
2010;10:56.
20. Suidan RS, Apuzzio JJ, Williams SF. Obesity, comorbidities, and the cesarean delivery
rate. Am J Perinatol. 2012;29:623-628.
21. Gilead R, Yaniv Salem S, Sergienko R,
Sheiner E. Maternal “isolated” obesity and
obstetric complications. J Matern Fetal Neonatal Med. 2012;25:2579-2582.
22.+HUPDQQ0/H5D\&%ORQGHO%*RIÀQHW
F, Zeitlin J. The risk of prelabor and intrapartum cesarean delivery among overweight and
obese women: possible prevention actions.
Am J Obstet Gynecol. 2015;212:241.e1-9.
23. Subramaniam A, Jauk VC, Goss AR, Alvarez MD, Reese C, Edwards RK. Mode of delivery in women with class III obesity: planned
cesarean compared with induction of labor.
Am J Obstet Gynecol. 2014;211:700.e1-9.
24. Subramaniam A, Corvey KJ, Kilgore ML,
Edwards RK. Planned cesarean delivery compared to induction of labor in women with
class III obesity: a cost-minimization analysis.
J Matern Fetal Neonatal Med. 2015;1.5. [Epub
ahead of print]
25. Gunatilake RP, Smrtka MP, Harris B, et al.
Predictors of failed trial of labor among women with an extremely obese body mass index.
Am J Obstet Gynecol. 2013;209:562.e1-5.
26. Edwards RK, Szychowski JM, Berger
JL, et al. Foley catheter compared with the
controlled-release dinoprostone insert: a
randomized controlled trial. Obstet Gynecol.
2014;123:1280-1287.
CONTEMPOR ARY OB/GYN
27
PRACTICE MATTERS
Lean and Six Sigma
These process improvement strategies from the business world
FDQEHXVHGHIIHFWLYHO\LQ\RXURIÀFH
by THOMAS LEE, MD, MBA, AND THE ASSOCIATION FOR MATERNAL FETAL MEDICINE MANAGEMENT
C
linicians’ efforts to help
our patients are increasingly being hampered
by the global systems
in which we practice.
Metrics addressing quality, cost, and
patient satisfaction often conflict with
our desires for work-life balance, appropriate financial remuneration, and
job satisfaction. Add to this the never-ending changes in healthcare reimbursement, billing and documentation requirements, and regulatory
considerations, and it is not surprising that a majority of clinicians in the
United States report flagging morale.1
Significant changes in how we practice medicine are urgently needed if
we are to continue to provide compassionate, high-value care to our patients
and their families within our current
healthcare environment. While global healthcare reform may be beyond
the scope of most clinicians, changing
Changing how your practice operates will help you handle growing
QUICK
TAKE
administrative mandates.
Streamline processes and cut out waste to make the most of your
patients’ time, your staff’s time and resources, and your own expertise.
how one’s practice operates and addresses the aforementioned issues is
something that is more realistic and
achievable.
How do we as front-line care providers bring about significant change
within our practices without formal
training? The unfortunate reality is
that healthcare operations are not
typically taught during medical training, yet have increasingly become a
part of our professional lives. This article is a high-level, non-MBA primer
on the concepts of Lean and Six Sigma
process improvement techniques—
concepts that may be increasingly
referenced in your day-to-day admin-
AMFMM’s mission is to create an
environment that facilitates individual and
organizational learning between managers
and physicians that enriches the MFM
patient experience while enhancing the MFM
business value.
28
CONTEMPOR ARYOBGYN.NE T
istrative discussions. The concepts of
Lean and Six Sigma can be used by
clinicians on the front lines to begin
to change how their practices operate.
Improving the efficiency of our office
practices by working smarter and not
necessarily harder can enhance the
experiences of our patients, provide
them with high-value care, and improve the financial performance of our
organizations.
Process improvement:
The bigger picture
Lean and Six Sigma do not stand alone.
Rather, they are essential components
of a global approach to workflow and
DR LEE is a maternal-fetal medicine specialist
at Northwest Perinatal Center Women’s
Healthcare Associates, LLC, Portland, Oregon.
+HKDVQRFRQÁLFWVRILQWHUHVWWRUHSRUWLQUHVSHFW
to the content of this article.
JUNE 2016
PRENATAL SCREENING
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informaSeq Prenatal Test
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10 weeks for patients who meet certain criteria. The
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XXX, XXY, XYY, and fetal sex.
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of gestation.
We take a personal
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Powered by Illumina® is a trademark of Illumina, Inc. in the US and/or other countries.
CFplus® and Inheritest® are registered trademarks of Laboratory Corporation of America® Holdings.
1. Xpert® GBS LB [package insert]. Sunnyvale, CA: Cepheid; November 2012. 301-0576.
2. Montague NS, Cleary TJ, Martinez OV, Procop GW. Detection of group B streptococci
in Lim broth by use of group B Streptococcus peptide nucleic acid fluorescent
in situ hybridization and selective and nonselective agars. J Clin Microbiol. 2008
Oct;(46)10:3470-3472.
PRACTICE MATTERS
efficiency improvement. Table 1 is
an example of a systematic approach
to process improvement. Within this
approach, Lean and Six Sigma reside
within the “process improvement”
phase.
Standardization is the foundation
for any process improvement initiative. Significant clinical variation is the
enemy of efficiency. This is not to say
that clinicians should not individualize care for select patients; however,
the starting point for most patients
should align with consensus-driven,
evidence-based protocols. How to accomplish that is beyond the scope of
this article, but progress on this issue
needs to occur prior to addressing process efficiency.
Lean
TABLE 1
Components of an approach to improving process
HIÀFLHQF\
CONTEMPOR ARYOBGYN.NE T
Understand what you want to improve and where you
Strategic plan
want to end up
Multidisciplinary
project team
Gather the right people to get you there
Process improvement
How you are going to get there
Deployment
Bringing it to fruition
Reinforcement and
reevaluation
Making sure it works, making sure it sticks, and making it
TABLE 2
better
7\SHVRIZDVWHLQKHDOWKFDUH
Overproduction
Lean production was initially developed by Taiichi Ohno at Toyota after
World War II and originated from the
company’s just-in-time production
practices as part of the Toyota production system. The conceptual origins
of Lean can be traced back through
history, from the standardized manufacture of crossbows seen under the
Chinese emperor Qin Shi Huangdi in
221 BC to the automobile production
lines developed by Henry Ford.2 Lean
is fundamentally based upon the philosophy of kaizen, Japanese for “improvement.” Kaizen involves employees at all levels working collectively
toward incremental improvements.
Since its introduction, the Lean production approach has been widely adopted in many commercial fields and
it has also spread to healthcare.
Lean’s kaizen objective is to create
a seamless flow to the production process by reducing wasteful steps that
contribute to inefficiency. Within the
30
LEAN AND SIX SIGMA
'HÀQLWLRQ
Example
Producing more than is
Printing reports or labels when
demanded or before it is
they are not needed
needed to meet demand
Waiting
Time during which value
Providers waiting for a staff mem-
is not being added to the
ber or patient
product or service
Transportation
Unnecessary travel of the
Movement of patients or equip-
product within the system
ment from one area of the clinic to
another
Inventory
Holding or purchasing
Excess inventory of supplies and
raw materials, work-in-
pharmaceuticals
SURFHVVDQGÀQLVKHG
goods that are not immediately needed
Motion
Actions of operators that
Unnecessary movement of the
do not add value to the
staff to obtain supplies
product
Overprocessing
Unnecessary steps and
Unnecessary EMR documentation
procedures that do not
add value to the service
Defects
Production of a part or
Prescribing the incorrect medica-
service that is scrapped
tion to a patient
or requires rework
JUNE 2016
LEAN AND SIX SIGMA
PRACTICE MATTERS
FIGURE 1 SCHEMATIC OF VALUE STREAM MAPPING
Six Sigma
organizational
infrastructure
Process 2
Process 3
Process 4
Process 5
Cycle Time 1
Cycle Time 2
Cycle Time 3
Cycle Time 4
Cycle Time 5
Wait Time
Wait Time
Lean system, waste (known as muda)
can take numerous forms (Table 2).
When Lean process improvement is
applied to healthcare, the steps involved in care delivery are individually examined as to whether they either 1) add value to the end goal, or
2) are wasteful and do not add value
to the process. The ultimate goal of
Lean process optimization is to eliminate those steps that do not add value
to the delivery of care in your clinic—
Wait Time
leading to a more streamlined, efficient workflow.3
Many concepts and tools within the
Lean lexicon of process optimization
can assist in identifying and eliminating waste. The following are a few basic tools to consider using as you start
to minimize inefficiency.
Value-stream mapping
Value-stream mapping is a powerful
Lean tool that combines process map-
Wait Time
ping and time data into a single view
(Figure 1). Value-stream mapping
lists the individual steps within a process in order to identify value-added
steps and non-value-added steps that
contribute to the process cycle times
(the time it takes your staff to complete a task) and their associated wait
times (the time your patients wait in
between).
Value-stream mapping formally
documents the tasks your staff mem-
FIGURE 2 OB CLINIC EXAMPLE OF VALUE STREAM MAPPING
Reception
Type of
appointment
Look at
schedule
Change status
to arrived
Copy Ins,
ODL, update
demographics
Scan all
Print HIPAA
and disclosures
Collect copay
Change status
to checked in
1 min
8OWUDVRXQG
Waiting
Previous pt
delayed
Entering pt
demographics
Review
medical
records
Patient is late
Orders missing
or incomplete
AIDET
Scan patient
Fill out R4 and
print report
Change status
Pt to waiting
room
Drop report at
nurses’ station
Finding LMP
Status not
changed
Language
barrier
9 min
JUNE 2016
Retrieve pt
from waiting
room
36 min
Waiting
U/S behind
schedule
MA
Retrieve pt
from waiting
room
Grab report
Abnormal U/S
Pt stop at
restroom
Exam rooms
full
Take VS,
meds, allergies
No MA
available
Assess
situation
Awaiting report
Teaching and
handouts
Waiting
MA: provider
not available
Provider:
Review or
track down
records
Questions
Status
discrepancies
EMR
documentation
Get report
from MA
Review medical
records
9 min
Do research
Language
barrier
10 min
Physical exam
Answer
questions
Discuss plan
Review U/S,
data
Contact
referring
provider
Reviewing
report
3URYLGHU
Discuss
relevant
problems
and results
9 min
14 min
Reception
Pt walks up to
check out
Waiting
MA back in:
Education
Blood draw
Pt instructions
Provider:
Order labs
Schedule test,
procedure
Call referring
provider
Check out:
Missing orders
Pt questions
Language
barrier
Billing
questions
Identify orders
Schedule pt
Give
appointment
card
Collect
copay/balance
if indicated
2 min
4 min
CONTEMPOR ARY OB/GYN
31
PRACTICE MATTERS
bers are performing as part of the
chain of care. When these tasks and
actions (ie, processes) are then viewed
in conjunction with their associated
cycle times and wait times in this format, it should initiate discussion and
raise questions such as 1) What actually is the process in our office? 2)
Why are there variations among our
staff members? 3) Are all these steps
necessary? and 4) How do these processes contribute to the cycle times
and wait times? Once you start asking
these questions, the targets for process
efficiency frequently become readily
apparent.
One of the key benefits of valuestream mapping is that it helps to
identify actual problems in the workflow, rather than relying on perceived
anecdotal notions that you or your
staff may have about clinic inefficiency. Furthermore, it allows you to understand what your staff is doing, what
your patients are experiencing, and
where improvements can be made.
Spaghetti Diagrams
Unnecessary movement is a significant type of muda. A spaghetti diagram is a visual depiction of the movement of staff, patients, and supplies
within an office. The benefit of a spaghetti diagram is to first identify and
then minimize wasted or redundant
movement within the office workflow.
Insights from a spaghetti diagram may
lead you to change where supplies are
placed, where staff workspaces are located, or even the design of the office
layout.
LEAN AND SIX SIGMA
FIGURE 3 SPAGHETTI DIAGRAM OF
OFFICE VISIT MOVEMENT
DEXA
Ultrasound
Lab
)URQWRIÀFH
MA
MD
Supply Restroom
Reception
Exam Room
Exam Room
Patient
Sonographer
MD
MA
Procedure
Room
5 Whys Technique
Following a value-stream mapping
exercise, a structured process called
root-cause analysis is used to identify the factors that contribute to the
non-value-added steps identified by
the value-stream mapping. One type
of root-cause analysis is the 5 Whys
technique, which simply boils down to
repeatedly asking the question “Why?”
It is a way to peel away the layers of
symptoms to uncover the root cause of
a problem, since frequently the ostensible reason for a problem will lead you
to another question.4 Usually about
5 rounds is a good rule of thumb. An
advantage of the 5 Whys technique is
that it is a simple tool that can be used
without statistical analysis.
Six Sigma
Six Sigma was developed in the 1980s
at Motorola as their in-house quality
improvement initiative. The approach
has since been adopted by many other organizations such as GE and IBM
as part of their strategies to improve
product and service quality. Six Sigma
has also found a niche within many
healthcare organizations as part of
their quality improvement programs.5
The goal of Six Sigma is to eliminate
defects by removing variance within
manufacturing and business systems.
In contrast to Lean, Six Sigma’s techniques for quality improvement place
a much greater emphasis on data,
statistical analysis, and mathematical
modeling. In fact, the term six sigma
SIX SIGMA HAS FOUND A NICHE WITHIN MANY HEALTHCARE ORGANIZATIONS AS PART OF THEIR
QUALITY IMPROVEMENT PROGRAMS.
32
CONTEMPOR ARYOBGYN.NE T
JUNE 2016
PRACTICE MATTERS
LEAN AND SIX SIGMA
methodology incorporates the use of
a martial-arts-like hierarchical organizational infrastructure (Figure 4) along
with specialized training and certification to define the roles that each person plays within the Six Sigma process.
While formal Six Sigma certification
and its statistical methodology may
be beyond the scope of most practicing clinicians, several tools may be
useful in your approach to process
improvement.
FIGURE 4
SIX SIGMA
ORGANIZATIONAL
INFRASTRUCTURE
MOVEMENT
Champions
Master BB (1
for every 20 BBs)
Black Belts
(1-2%)
Green Belts (5-10%)
Yellow Belts (25-50%)
comes from the mathematical concept
that maintaining 6 standard deviations
of variation within the confines of the
process tolerance limits will nearly
eliminate products that fail to meet
required specifications (with the goal
of no more than 3.4 defects per million opportunities). Formal Six Sigma
The DMAIC Cycle
A commonly used Six Sigma tool is the
Define-Measure-Analyze-ImproveControl (DMAIC) cycle (Figure 5). The
DMAIC cycle is composed of the following phases:
1. Define: understand the problem to be solved or the process to be
improved.
2. Measure: understand how the
current state is meeting the clinic’s
requirements.
3. Analyze: examine collected data
to determine the influential variables.
4. Improve: identify solutions and
FIGURE 5
THE DMAIC CYCLE
'HÀQH
Control
Measure
Improve
Analyze
implement.
5. Control: hardwire the changes to
maintain the gains achieved.
Using this series of steps as a roadmap allows your team to systematically gain an understanding of the process that you are trying to improve and
work toward a sustainable solution.
Seven Basic Quality Tools
Six Sigma employs 7 basic quality conCONTINUED ON
PAGE 41
FIGURE 7 FLOWCHART OF AN OFFICE VISIT
Patient arrives and
is checked-in by
reception
Reception
QRWLÀHVVRQRJUDSKHU
Sonographer
escorts patient to
ultrasound
Pelvic
ultrasound exam
performed
MA obtains vital
signs & reviews
history
MA escorts patient
to exam room
Sonographer
QRWLÀHV0$
Patient escorted to
waiting room
MA reports to
provider
Provider sees
patient for exam
and endo bx
Patient directed
to reception to
schedule visit
Follow-up visit
scheduled and
patient released
JUNE 2016
CONTEMPOR ARY OB/GYN
33
ACOG GUIDELINES AT A GLANCE
EXPERT PERSPECTIVES ON PRACTICE BULLETINS
COMMITTEE ON PRACTICE BULLETINS—OBSTETRICS Practice Bulletin No. 154: Operative Vaginal Delivery.
November 2015 (Replaces Bulletin No. 17, June 2000). American College of Obstetricians and Gynecologists. Obstet Gynecol.
2015;126:e56-65. Full text of ACOG Practice Bulletin available to ACOG members at http://www.acog.org/Resources_And_Publications/Practice_Bulletins/Committee_on_Practice_Bulletins_--_Obstetrics/Operative_Vaginal_Delivery.
OPERATIVE VAGINAL DELIVERY Despite significant
or vacuum extractor requires that an obstetrician and obstet-
changes in management of labor and delivery over the past
ric care provider be familiar with the proper use of the instru-
few decades, operative vaginal delivery remains an impor-
ments and the risks involved. The purpose of this document is
tant component of modern labor management, accounting
to provide a review of the current evidence regarding the ben-
for 3.30% of all deliveries in 2013 (1). Use of obstetric forceps
efits and risks of operative vaginal delivery.
Used with permission. Copyright the American College of Obstetricians and Gynecologists.
COMMENTARY
Operative vaginal delivery: a lost art
by CHARLES J LOCKWOOD, MD, MHCM
Dr Lockwood is Senior Vice President,
USF Health and Dean, Morsani College
of Medicine, University of South Florida,
Tampa, and Editor in Chief of Contemporary
OB/GYN.
When I was a resident I performed
more than 250 operative vaginal deliveries, mostly with forceps, and many
after rotation. I suspect many practitioners of my generation compiled
similar numbers during their training.
Well, times have changed. Whereas
in 1990 slightly more than 9% of livebirths resulted from either forceps delivery (5.11%) or vacuum extraction
(3.9%), by 2014 only 3.21% of livebirths
resulted from operative vaginal delivery and forceps accounted for less
than 20% of these births (0.57% of all
live births).1
The latest ACOG Practice Bulletin
34
CONTEMPOR ARYOBGYN.NE T
on this subject serves as an excellent
summary of the indications, prerequisites, advantages, and overall safety of
this increasingly lost art.2
Operative vaginal delivery is indicated for both maternal and fetal reasons. The former include exhaustion
and ineffectual pushing in the second
stage of labor as well as various medical and obstetrical factors requiring an
expedited second stage. Such factors
include preexisting cardiovascular
disease, deteriorating medical conditions (eg, hypertension, sepsis), prolonged second stage of labor, arrest of
descent or the need to rotate the fetal
head to effect vaginal delivery. In cases
of nonreassuring fetal heart rate (FHR)
tracings, operative vaginal delivery
may not only obviate the short- and
long-term maternal morbidities of cesarean delivery but avoid progressive
fetal ischemia.
While the Practice Bulletin retains
the traditional classification system
for outlet, low and mid-forceps deliveries (see Box 2), ACOG points out
that in general, the lower the fetal head
in the pelvis and the less rotation required, the less the risk of maternal
and fetal injury. Vaginal birth is more
likely to be achieved with forceps than
with vacuum extraction, but the former has about twice the rate of associated 3rd- or 4th-degree perineal tears.
However, despite this higher rate of
perineal trauma, when compared with
outcomes for cesarean delivery, forceps delivery was not associated with
higher rates of pelvic floor or sexual
dysfunction in primiparous women 1
year postpartum.3 In addition, no differences in bowel or bladder function
were found between women delivered
by forceps versus vacuum extraction at
5 years.4
JUNE 2016
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breakthrough ingredient PurCellin Oil™. For comprehensive product information
please visit biooilhealth.com. Bio-Oil is the No.1 selling scar and stretch mark
product in 18 countries. $11.99 (2fl.oz).
ACOG GUIDELINES
The Practice Bulletin does caution
against the routine use of episiotomy
with operative vaginal delivery given
its association with perineal trauma.
Forceps delivery has been associated with fetal facial lacerations and
nerve palsy, ocular trauma, skull fractures and intracranial hemorrhage,
while vacuum extraction has been
linked to fetal scalp lacerations, cephalohematoma formation, subgaleal and
retinal hemorrhage. Fortunately, all
these risks are low. While neurological
complications occur in 1 of 220 to 385
infants having operative vaginal deliveries, these rates must be compared
OPERATIVE VAGINAL DELIVERY
This study found that the absolute risk
of neonatal mortality from intracranial
hemorrhage was 3 to 4 per 10,000 for
both instruments. Long-term neurological outcomes also appear comparable among infants delivered spontaneously versus by operative vaginal
delivery.7
The Practice Bulletin also addresses
the contentious issue of operative vaginal delivery of the macrosomic infant.
The authors note that the risk of persistent injury is comparable between
macrosomic infants who were delivered spontaneously compared with
operative vaginal delivery, suggesting
THE PRACTICE BULLETIN ALSO ADDRESSES THE CONTENTIOUS
ISSUE OF OPERATIVE VAGINAL DELIVERY
OF THE MACROSOMIC INFANT.
to those delivered by, often emergent,
cesarean section. For example, using
seizure, intraventricular hemorrhage,
and subdural hemorrhage as collective indicators of adverse neurologic
outcome, forceps deliveries were associated with a reduced risk of such
outcomes compared with both vacuum extraction (odds ratio 0.60; 95% CI:
0.40-0.90) and cesarean delivery (OR
0.68; 95% CI: 0.48-0.97).5
Similarly, while vacuum deliveries were associated with higher rates
of scalp laceration, fracture, and brachial plexus injury compared with cesarean, they were not associated with
excess neurological injury. Indeed,
Walsh and associates noted that when
compared with cesarean delivery in
the 2nd stage of labor, operative vaginal delivery accrued similar rates of
neonatal death and encephalopathy.6
36
CONTEMPOR ARYOBGYN.NE T
that it is the macrosomia rather than
the mode of vaginal delivery which is
the culprit. The Practice Bulletin concludes that “judicious use of operative
vaginal delivery for infants with suspected macrosomia is not contraindicated.” The authors do point out that
the adequacy of the pelvis and the
progress of labor, especially the 2nd
stage, should be carefully considered
in this setting and preparations made
for a possible shoulder dystocia.
Among the recommendations made
by ACOG are:
r0QFSBUJWFWBHJOBMEFMJWFSZJTDPOtraindicated if the fetal head is unengaged or its position is unknown, or
if a fetal demineralizing or bleeding
condition is suspected; and it should
be performed only by experienced obstetricians with the appropriate hospital privileges.
r 8IJMF DFTBSFBO EFMJWFSZ BGUFS
“failed” operative vaginal delivery in
the setting of a nonreassuring FHR
tracing is associated with increased
neonatal morbidity, this risk must be
weighed against the benefits of an
expedited delivery when operative
vaginal delivery is successful in this
setting. On balance, ACOG prudently
opines that “A trial of operative vaginal delivery is an appropriate option
[when] the obstetrician [...] feels the
chances of success are high, but must
be prepared to abandon the attempt if
appropriate descent does not occur.”
r#FDBVTFPGJODSFNFOUBMGFUBMBOE
maternal risk, sequential use of vacuum extraction and forceps or vice versus should not be routinely performed.
r 8IJMF UIF SJTL PG DFQIBMPIFNBtoma increases with the duration of
vacuum application, particularly after
5 minutes, release of vacuum pressure
between contractions does not appear to be associated with improved
outcomes.
r 'PSDFQT SPUBUJPOT UP FŀFDU EFMJWery are not linked to excess neonatal
neurological morbidity. Furthermore,
because forceps rotation of a fetus in
a persistent occiput posterior position
to an occiput anterior position may reduce maternal perineal laceration, it
seems reasonable to attempt manual
or forceps rotation of fetuses in certain
such circumstances.
r7BDVVNFYUSBDUJPOJTEJTDPVSBHFE
at gestational ages less than 34 weeks.
r /FPOBUBM QSPWJEFST TIPVME CF
made aware of an operative vaginal
delivery to facilitate observation for
related complications. FOR REFERENCES VISIT
contemporaryobgyn.net/ACOG-PB154
JUNE 2016
FIRST PERSON
OBSTETRICS
Get a handle on the
Scanzoni maneuver
This forceps-aided rotation can be used when the fetus is occiput
posterior and the head is low in the pelvis.
by SARAH CIGNA, MD, MS; NANCY D GABA, MD; AND JOHN W LARSEN, JR, MD
For this technique, we use Tucker-McLane forceps with Luikart
Clinical scenario
Your patient has had a long, slow labor, with pain predominantly in her
back (the infamous “back labor”). She
is now fully dilated and the head has
progressed well into the pelvis, but it is
not crowning, and you find that the patient’s exam is notable for right occiput
posterior (OP) position. The patient
is exhausted. She has tried a number
physical maneuvers and labor positions with minimal progress. Manual
rotation of the head was unsuccessful.
The choice at this point is to move to a
cesarean delivery or to try a Scanzoni
rotation to turn the head with forceps
with physicians aiding the rotation
abdominally. A cesarean delivery is
less desirable in this case as the head is
wedged down deep in the pelvis.
JUNE 2016
QUICK
TAKE
PRGLÀFDWLRQEHFDXVHWKH\UHVXOWLQIHZHULQMXULHVWRWKHIHWDOIDFLDOVNLQ
The angle of the shanks in relation to the maternal spine is crucial. A
ZLGHDQJOHUHVXOWVLQDSSURSULDWHWRUTXHDQGPDLQWDLQVÁH[LRQRIWKHIHWDO
neck throughout rotation.
History
The Scanzoni maneuver was invented
by Friedrich Wilhelm Scanzoni, a German obstetrician, in 1849. His method
for changing a posterior presentation into an anterior one required the
use of forceps twice in the process of
delivery.1
Context
OP positions are the most common
type of malposition, cited to comprise
between 1% and 5%.2 They are often
accompanied by some degree of deflexion, resulting in a larger presenting
diameter. The presence of asynclitism
and molding can make it difficult to
correctly determine position, leading
to an inaccurate diagnosis of occiput
anterior (Figure 1). Risk factors for OP
position include smaller pelvic outlet
capacity, prior OP, nulliparity, maternal age >35, gestational age ≥41 weeks,
birth weight >4000 g, artificial rupture
of the membranes (AROM), and epidural anesthesia.3 OP position as a cause
DR CIGNA is a resident
DR GABA is
DR LARSEN is Professor of Obstetrics
physician in the Department
Professor and Chair
and Gynecology at The George
of Obstetrics and
of the Department of
Washington University, Washington, DC.
Gynecology, The George
Obstetrics at The George
1RQHRIWKHDXWKRUVKDVDFRQÁLFWRI
Washington University
Washington University,
interest to report in respect to the content
Hospital, Washington, DC.
Washington, DC.
of this article.
CONTEMPOR ARY OB/GYN
37
FIRST PERSON
OBSTETRICS
for persistent labor dystocia can be corrected using the Scanzoni method, allowing successful vaginal delivery.
Maternal
Anterior
Forceps
“False”
posterior
fontanel
True position is ROP
False perception
of position is LOA
Maternal
Posterior
FIGURE 1 Black outline: fetal head in true right occiput posterior position. Gray
RXWOLQHGHSLFWVWKHFRPPRQO\PLVWDNHQLGHQWLÀFDWLRQRIWKHSRVWHULRURFFLSXW
DVOHIWRFFLSXWDQWHULRUHVSHFLDOO\LQFDVHVZLWKVLJQLÀFDQWPROGLQJ
forceps with Luikart modification for ease of application and
find that they result in fewer injuries to the fetal facial skin.
Technique
Overlapping
shanks corrects
asynclitism
FIGURE 2A Correction of asynclitism with articulation of the forcep shanks.
38
CONTEMPOR ARYOBGYN.NE T
For successful completion of
the Scanzoni maneuver, the patient should be in the dorsal lithotomy position. To begin, the
forceps are applied to the head
in the usual fashion, with the
posterior blade placed first, and
the anterior blade second. The
blades should be oriented with
their pelvic curve aligned to the
curve of the maternal sacrum,
as with any forceps placement.
The blades are then articulated
so that they overlap and the
handles squeezed together to
lock the blades in place around
the head which corrects the
asynclitism (Figure 2A). The
next portion of this maneuver is
initiated by using the forceps to
flex the fetal neck and dislodge
the malpresenting cranium. The
shanks of the forceps should be
directed in a wide arc beginning
between 12- and 3-o’clock, and
ending at 6 o’clock, essentially
“screwing out” the head with
the natural forces of contraction
as well as laterally directed pressure on the abdomen applied by
an assistant (Figure 2B 1,2).
The lateral pressure serves to
rotate the shoulder simultaneously with the head. The angle of
JUNE 2016
ILLUSTRATION BY ALEX BAKER, DNA ILLUSTRATIONS, INC.
Our preferred forceps to use for Scanzoni rotation are Tucker-McLane, in
this case with the Luikart modification. Tucker-McLane forceps feature
solid rather than fenestrated blades.
The Luikart modification is a pseudofenestration. Most importantly,
unlike the Simpson forceps blades
with their widely separated shanks,
the shanks of the Tucker-McLane forceps are overlapping. This decreases
the risk of a tear during the wide rotation when correcting the position of
the head. An article by W Barth, MD,
recently published in Obstetrics & Gynecology, described rotational forceps
using the Kielland forceps followed by
Simpson forceps for traction and delivery.4 We find that the Scanzoni maneuver is preferable to facilitate successful delivery of a persistently OP
baby. We favor the solid pseudofenestrated blades of the Tucker-McLane
FIRST PERSON
OBSTETRICS
1. Flexion
of neck
2. Rotation of
head in
wide arc
FIGURE 2B After correction of asynclitism (depicted by solid outline forceps),
WKHKHDGLVÁH[HGE\DQJOLQJWKHIRUFHSVXQWLOSDUDOOHOWRWKHPDWHUQDOOHIW
thigh and then rotated in a wide arc until the head is in occiput anterior
position (shown as progressively darker dotted outline).
ILLUSTRATION BY ALEX BAKER, DNA ILLUSTRATIONS, INC.
the shanks in relation to the maternal
spine is crucial. The shanks should be
oriented almost vertically, perpendicular to the maternal spine, almost parallel to the maternal thighs in the dorsal lithotomy position. It is this wide
angle that gives the operator an appropriate amount of torque and more
importantly, maintains flexion of the
fetal neck throughout rotation. Once
rotation is complete, the blades must
be switched in order to realign them
with the maternal pelvic curve. This is
easiest if done between contractions
(Figure 2C). Removal and replacement of the forceps should be done
following the curve of the blades, as in
any forceps maneuver. The blade that
is now posterior can be removed and
replaced inside the anterior blade. The
anterior blade is then removed and replaced posteriorly. Keeping one blade
in place at all times will splint the head
in its rotated position, preventing reversal of rotational progress.
Finally, the forceps can be rearticulated and used to guide the head out
to crowning station (Figure 2D). At this
point the blades should be removed
and the head and body delivered with
maternal effort to avoid unnecessary
trauma to the perineum. Management
of the third stage of labor can proceed
in a standard fashion. REFERENCES
1. Merriam-Webster.com. Scanzoni Maneuver. http://www.merriam-webster.com/medical/scanzoni%20maneuver. Accessed April
20, 2015.
2. Sizer AR, Nirmal DM. Occipitoposterior
position: associated factors and obstetric outcome in nulliparas. Obstet Gynecol.
2000;96(5):749–752.
3. Cheng YW, Shaffer BL, Caughey AB. Associated factors and outcomes of persistent
occiput posterior position: A retrospective cohort study from 1976 to 2001. J Matern Fetal
Neonatal Med. t in2006;19(9):563–568.
4. Barth W. Persistent occiput posterior. Obstet Gynecol. 2015;125(3):695–709.
Head guided to
crowning station
Reapplication
of forceps
between contrations
FIGURE 2C Rotation of head is maintained during reapplication
of the forceps by keeping one blade in place at all times.
JUNE 2016
Figure 2D Head is guided to crowning station with usual
low forceps delivery technique.
CONTEMPOR ARY OB/GYN
39
LEGALLY SPEAKING
OB/GYN VERDICTS AND SETTLEMENTS
Did induction cause this uterine rupture?
CONTINUED FROM PAGE 48
Although no episiotomy was needed,
some second-degree tears were immediately repaired.
The plaintiff experienced postpartum hemorrhage, which Dr B diagnosed as uterine atony because the
uterus was boggy and soft. Oxytocin
was administered at about 9:19 pm
to treat the atony and hemorrhage.
plaintiff’s uterus, although she would
have to deliver any future children via
cesarean. Following the successful
surgery, Dr B informed the plaintiff
that she had never heard of dinoprostone causing uterine rupture.
Resident doctors likewise told the
plaintiff that a uterine rupture is not a
common occurrence.
THE DINOPROSTONE CAUSED
THE UTERINE RUPTURE AND THAT THE DEFENDANTS
THEY CLAIMED THAT
DEVIATED FROM THE STANDARD OF CARE.
The plaintiff was given an injection of
methylergonovine at about 9:45 pm,
also to treat the atony and hemorrhage. When the methylergonovine
appeared ineffective, Dr B ordered
400 mg of misoprostol, half the usual
dose, to be administered rectally.
The bleeding ceased and the
plaintiff appeared to be recovering
until approximately 10:55 pm, when
she experienced pain, dizziness, and
vomiting. Dr B ordered fluids and
attempted to determine the cause of
the plaintiff’s symptoms. A bedside
ultrasound was inconclusive, but
a second ultrasound revealed fluid
around the uterus.
Dr B took the plaintiff to the operating room to perform an exploratory
laparotomy, where she discovered
that the plaintiff had sustained a
10-cm posterior uterine rupture. She
undertook the repair and saved the
40
CONTEMPOR ARYOBGYN.NE T
$OOHJDWLRQV
The plaintiff’s lawyer claimed that
the defendants did not appropriately monitor the plaintiff after the
insertion of the dinoprostone and
negligently prescribed dinoprostone,
misoprostil, and oxytocin to induce
labor. They claimed that the dinoprostone caused the uterine rupture and
that the defendants deviated from the
standard of care in failing to perform
serial vaginal examinations of the
patient and in ordering dinoprostone
and oxytocin after the delivery in an
to attempt to control bleeding. They
also contended that misoprostol was
not utilized for its Food and Drug
Administration-approved purpose.
'LVFRYHU\
Dr B testified that her plan was to
use the dinoprostone to start induction and “prevent [the plaintiff ] from
getting chorioamniotis, sepsis, and
ending up with a C-section,” she said.
She further testified, “ … the plan is
always with somebody who has such
an unfavorable cervix and ruptured
membranes is to use a cervical ripening agent in the hopes that we will be
able to start Pitocin augmentation
with a better outcome.” According to
Dr B, in a patient such as the plaintiff,
who tested positive for GBS and had
ruptured membranes, the most pressing concern is to prevent infection,
and that is why dinoprostone was
used. As for the perforation, despite
such a rupture being, in her words, “a
major adverse event, a really, really
rare thing” often requiring hysterectomy, Dr B was able to successfully
repair the rupture, and as she said,
“save her life, save her uterus.”
The plaintiff recalled that Dr B “told
me that she didn’t expect to check me
until I got the Pitocin, unless I wanted
an epidural.” She claimed that “immediately” upon the insertion of
dinoprostone she began experiencing lower abdominal pain and this
precipitated the 2 pm request for an
epidural. The plaintiff acknowledged
that the doctors at the hospital all told
her that she “almost died,” saying, “it’s
a miracle that you’re still here.” The
plaintiff’s husband likewise thanked
Dr B “so much,” saying, “I thought
she was going to die. You saved her
life.” The plaintiff performed Internet
“research” and found that “a uterine
rupture is an adverse effect of Cervidil, and that the patient should be
monitored for pain, as pain is not really common with Cervidil and pain
JUNE 2016
LEGALLY SPEAKING
OB/GYN VERDICTS AND SETTLEMENTS
is an indication that something might
be going wrong with the Cervidil.”
5HVROXWLRQ
Armed with expert support, we
moved for summary judgment dismissing all claims. Our ob expert
opined that the plaintiff’s assertions
regarding use of misoprotsol and oxytocin “during labor” lacked merit and
they were used after labor. She stated
that the patient was an appropriate
candidate for dinoprostone given that
there was no cervical dilatation or
active labor for 7 1/2 hours after her
water broke. It was good practice to
remove the dinoprostone only when
the patient went into active labor
and to avoid vaginal examinations
given her GBS status. There was no
evidence either of uterine hyperstimulation or of dinoprostone causing
or contributing to uterine rupture
in this prima gravida. In opposing
the motion to dismiss, the plaintiff’s
expert argued that the defendants
departed from good practice in failing
to remove the dinoprostone in the
face of hyperstimulation and active
labor. They claimed a failure to perform vaginal exams during 7 hours of
labor and that dinoprostone “on rare
occasions” can cause rupture in a
“pristine” or unscarred uterus. In reply, we submitted literature
on uterine rupture with concomitant
dinoprostone use that did not recognize dinoprostone as a causal factor
in rupture of a pristine uterus. We
also challenged the opposing expert’s
LEAN AND SIX SIGMA
CONTINUED FROM
PAGE 33
trol tools to help maintain consistency
of products and services. These tools
were first popularized by Kauro Ishikawa, who believed that up to 95% of
quality-related problems could be addressed with these fundamental tools.3
r 'JTICPOF EJBHSBN B DBVTFBOE
effect tool useful in root-cause analysis (Figure 6, online)
r $IFDL TIFFU B DVTUPN EBUB DPMlection form to track quantitative and
qualitative data on problems and defects in real time
r )JTUPHSBN B HSBQI UP JMMVTUSBUF
probability or frequency distributions
r 1BSFUP DIBSU B TPSUFE IJTUPHSBN
that focuses on the most influential
factors; based upon the Pareto principle that 80% of costs, issues, or defects
can be attributed to 20% of the items
JUNE 2016
being measured
r'MPXDIBSUBQSPDFTTNBQ'JHVSF
r 4DBUUFS QMPU B HSBQI PG UIF SFMBtionship between 2 factors, suggesting
either causation or correlation
r3VODIBSUBDISPOPMPHJDQMPUPGB
process metric, useful in examining
trends
Best of both worlds
Much of how all this business theory
applies to healthcare may be overwhelming to a clinician or practice
manager who does not have formal
training in Lean or Six Sigma. The 2
approaches overlap substantially, and
many organizations have advocated
the use of Lean and Six Sigma philosophies and tools in tandem as what is
known as Lean Six Sigma. In this author’s opinion, the combined Lean
diagnosis of tachysystole as inconsistent with the record.
7KHYHUGLFW
The court granted our moWLRQIRUGLVPLVVDOÀQGLQJWKDW
although the plaintiff’s expert
created a question of fact as
to when the patient went into
active labor, he was unable to
meet his burden of proof with
regard to the use of dinoprostone being a departure from
good practice or causing the
rupture at issue.
PRACTICE MATTERS
Six Sigma approach is better for use
within healthcare because it brings
together the goals of Lean’s reduction
of waste and Six Sigma’s reduction of
process variability.
Figure 8 is a conceptual illustration
of how these 2 systems can be used
together in the clinical realm. Imagine
that points A and B represent the beginning and end of a clinical process
such as seeing a patient for a LEEP.
The steps involved in completing the
procedure are represented by each
oval (eg, check-in, notifying the MA,
reviewing the chart and indications,
setting up the procedure room, retrieving the patient, notifying the MD,
etc.). Each step in the process is characterized by an “amplitude” that represents the variability for that specific
CONTINUED ON
PAGE 42
CONTEMPOR ARY OB/GYN
41
PRACTICE MATTERS
CONTINUED FROM
PAGE 41
step, since each staff member is likely
to have a slightly different way of completing that task. In order to improve
efficiency, Lean techniques can be
used to eliminate wasteful (or non-value-added) steps and thereby reduce
the overall length of the process. Six
Sigma techniques can also be brought
to bear on the process to reduce the
workflow variation among staff members (through work standardization),
which is represented by a reduction in
the amplitude of the step. The end result is a more streamlined, less wasteful workflow for performing the LEEP,
which is the ultimate goal of your efficiency improvement efforts.
6XPPDU\
Lean and Six Sigma systems contain
a wealth of tools and techniques that
can be used to improve the quality
and efficiency of your practice. Having a general understanding of the
differences between Lean and Six Sigma along with how they can also work
in synergy is the first step in getting
started. Remember though that these
tools do not stand alone and should
be incorporated into a sequential approach that starts with development
of an organizational strategic plan
and a multidisciplinary process improvement team. Folding a DMAIC
structure, value-stream mapping,
and root-cause analyses into the efficiency improvement process comes
later. However, knowledge of the tools
you will have available when that time
comes should give you confidence in
taking that first step.
With a good roadmap and the right
tools, the goals of providing higher-value healthcare, increased patient and
provider satisfaction, and improved
42
CONTEMPOR ARYOBGYN.NE T
LEAN AND SIX SIGMA
FIGURE 8 CONCEPTUAL ILLUSTRATION
OF LEAN SIX SIGMA
B
A
A
A
financial performance are attainable
for providers and offices on the front
lines of care delivery. Resources are
available for those who are inspired to
rise to the challenge. REFERENCES
1. Ray W, Norbeck T. Survey of 20,000 physicians reports morale still low, but slightly improving. Forbes (2014 Oct 3). Retrieved February 14, 2016 from http://www.forbes.com/
sites/physiciansfoundation/2014/10/03/survey-of-20000-physicians-reports-morale-stilllow-but-slightly-improving/#3304cd2724d5
2. Hunt B. The history and simplicity of Lean
process improvement. Process Excellence
Network (2009 July 7). Retrieved February 14,
2016 from http://www.processexcellencenetwork.com/lean-six-sigma-business-transformation/articles/the-history-and-simplicity-oflean-process-improve/
3. McLaughlin DB, Olson JR. Healthcare operations management, 2nd ed. Chicago, IL:
Health Administration Press; 2012.
4. iSixSigma. (2015). Determine the Root
Cause: 5 Whys. Retrieved July 2, 2015, from
http://www.isixsigma.com/tools-templates/
cause-effect/determine-root-cause-5-whys/
B
B
LEAN
SIX SIGMA
5. Bandyopadhyay JK, Coppens K. Six Sigma
approach to healthcare quality and productivity management. Int J Productivity and Quality
Management. 2005;5(1):V1-V12.
SUGGESTED RESOURCES
Cohen F, Dahl O. Lean Six Sigma
for the medical practice: Improving profitability by improving
processes. Phoenix, MD: Greenbranch Publishing; 2010.
Lighter DE. Basics of health care
performance improvement: A
Lean Six Sigma approach. Burlington, MA: Jones & Bartlett
Learning; 2013.
McLaughlin DB, Olson JR.
Healthcare operations management, 2nd ed. Chicago, IL: Health
Administration Press; 2012.
Suneja A, Suneja C. Lean doctors.
Milwaukee, WI: American Society
for Quality, Quality Press; 2010.
JUNE 2016
2016
Annual Meeting
The Science and Art
of Menopause Health
Marriott Gaylord Palms Hotel
Orlando, Florida
October 5-8, 2016
The Continuing Education program will cover these topics:
Q
Q
Q
Q
Q
Q
Q
Q
Q
Q
Q
Cardiovascular Disease Risk Assessment
Controversies in the Medical Management of DCIS
Hormone Therapy and Nonhormonal Management of Menopause Symptoms
Osteoporosis Risk and Treatment Options
The Evolution of Desire
Vulvar and Vaginal Health
The History and Basic Science of Soy Isoflavonoids
Nutritional Needs for the Midlife Woman
Flibanserin—Are We Evening the Score?
The Natural History of Menopause Symptoms
And much more
Pre-Meeting Symposium
Menopause and the Brain: Maximizing Cognitive
and Psychological Well-being at Midlife
Presentations will address mood changes, screening and treatment of
depression and anxiety, cognitive changes and complaints, and sleep,
with interactive panel discussions.
For More Information
www.menopause.org/2016-scientific-program
308
MARKETPLACE
For Products & Services Advertising, contact: Joanna Shippoli
(800) 225-4569 ext. 2615, [email protected]
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Repeating an ad ENSURES
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44
CONTEMPOR ARYOBGYN.NE T
Joanna Shippoli
Account Manager
440-891-2615
[email protected]
JUNE 2016
For Recruitment Advertising, contact: Joanna Shippoli
(800) 225-4569 ext. 2615, [email protected]
CAREERS
CALIFORNIA
NATIONAL
Get a Life...
OBSTETRICS/GYNECOLOGY PHYSICIAN
Olive View-UCLA Medical Center, a Los Angeles County facility and
major teaching hospital for the David Geffen School of Medicine
at UCLA, is recruiting a full-time BC/BE general obstetrician/
gynecologist.
We are seeking individuals who will contribute to an academic,
energetic and creative multidisciplinary faculty. Responsibilities
include direct patient care with strong emphasis on mentoring and
training residents in the UCLA Ob/Gyn Residency Program, as well
as the teaching of medical students. Opportunities in clinical and
basic science research are available and encouraged. Employment
includes an academic appointment at the David Geffen School
of Medicine at UCLA. Competitive salary and benefits provided.
Applicants at the level of Assistant or Associate Professor will be
considered. This is an excellent opportunity in sunny Southern
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for licensure in California. EOE
…follow your passion
Play a pivotal role in improving the health of women
ĂŶĚďĂďŝĞƐŶĂƟŽŶǁŝĚĞ^ĞĞLJŽƵƌƐĞůĨƉƌĂĐƟĐŝŶŐƚŚĞ
ŵĞĚŝĐŝŶĞLJŽƵĚĞƐŝƌĞĂŶĚůŝǀŝŶŐƚŚĞůŝĨĞLJŽƵĚĞƐĞƌǀĞ
In 2016, OBHG celebrates 10 years of ĞůĞǀĂƟŶŐƚŚĞ
ƐƚĂŶĚĂƌĚŽĨǁŽŵĞŶƐŚĞĂůƚŚĐĂƌĞKƵƌƚĞĂŵŝŶĐůƵĚĞƐ
more than 450 skilled physicians who serve a network
of nearly 100 hospitals in ϮϱƐƚĂƚĞƐŶĂƟŽŶǁŝĚĞ
Please submit letter of intent, CV, and three references to:
Dr. Christine Holschneider
Chair, Department of Obstetrics and Gynecology
Olive View- UCLA Medical Center
14445 Olive View Drive, 6D-116
Sylmar, CA, 91342
Fax: (818) 364-3255
Email: [email protected]
www.OBHG.com
INDIANA
%NKPKE
OBGYN OPPORTUNITY
t
t
t
t
t
t
Each physician has a consistent nurse with the addition of a few float nurses
Average of 25 – 35 clinic patients per day
Clinic Hours: Monday – Friday 9:00 am – 5:00 pm – No Weekends
Approximately 1 – 1.5 clinic days dedicated to OB and 2 – 2.5 clinic days dedicated to GYN patients
Average work week is 4 – 4.5 days per week
Clinic is divided into blocks of OB patients and blocks of GYN patients by full or half day increments
1RRQTVWPKV[
Schneck Medical Center is seeking a Board
%GTVKƂGF'NKIKDNG1$);0 to join their
established traditional OB/GYN Practice.
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Physician is leaving practice to move back to Montana
Will see patients from existing patient base and new patients
Hospital employed position
Practice has an impeccable reputation - represented by their 80% market share in home county
and growing market share in surrounding counties
Physicians have similar training and work extremely well together
$80,000 Sign-on Bonus, $2,500/month stipend, Salaried Position
304 PTO hours per year + 24 CME PTO hours per year
$2,500 per year CME allowance + $1,000 electronic/educational material allowance
Centrally Located in Southern Indiana Seymour, Indiana is located just off Interstate 65 in the southern part of the state. Seymour is a one hour drive from
Indianapolis, Louisville, and Bloomington, home of Indiana University, and only 90 minutes from Cincinnati. A city of tree-lined streets, beautifully restored
historical homes, and quaint shops, yet close to the cultural and entertainment amenities of the bigger cities. Excellent school system offering both
public and parochial education options. Thriving manufacturing industry helps promote low unemployment and a robust economy.
FOR CONTACT INFO USE : Fayeann Hurley,1IZTJDJBO3FDSVJUFSt4DIOFDL.FEJDBM$FOUFStPGmDFt')VSMFZ!TDIOFDLNFEPSH
Place a recruitment ad in Contemporary OB/GYN.
JUNE 2016
CONTEMPOR ARY OB/GYN
45
CAREERS
ILLINOIS
OSF Saint Francis Medical Center – Peoria, IL Opportunity
for a Physician to join our OB/GYN Hospitalist team slated to
begin at OSF Saint Francis Medical Center in Peoria, IL. The ideal
candidate will be board-certified in OB/GYN (MD or DO),
be able to demonstrate clinical excellence with superior
communication skills, and have a focus on providing quality care
placing the patient above all other considerations. Qualifications
also include active and current skills in the full breadth of the OB/
GYN specialty, a current Illinois license to practice or near the end
of the licensure process. Other requirements include a willingness
to drive patient safety and quality initiatives as required by the
TeamHealth Patient Safety Organization, insurability for malpractice
insurance, at least 2 years of active practice, and a successful
track record. TeamHealth offers competitive compensation plus
paid professional liability insurance with tail coverage.
Narrow your candidate search to the best.
Place a recruitment ad in Contemporary OB/GYN.
Joanna Shippoli
National Account Manager, Healthcare Careers
(440) 891-4569 | [email protected]
To learn more about these or other Hospital Medicine
opportunities, contact Jonathan Goldsmith at
954.377.3081 or [email protected],
or visit www.teamhealth.com.
MASSACHUSETTS
A well-established, full-scope community Ob/Gyn practice is seeking a
full-time BC/BE physician to join their busy and growing practice.
This practice includes MD’s, CNM’s and NP’s with a large experienced
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state of the art 3D ultrasound, maternal fetal medicine consults, Level
II ultrasound as well as a minimally invasive trained gyn surgeon. Our
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VDWHOOLWHRI¿FHVVHHLQJSDWLHQWVDVZHOO+RVSLWDORIIHUVKRXULQKRXVH
anesthesia and pediatric coverage. The hospital maintains strong clinical
collaborations with Boston’s academic centers ensuring that physicians
have access to world-class resources.
UTAH
Intermountain is frequently referenced nationally as one of
the leaders in delivering high quality/low cost healthcare.
Intermountain Healthcare needs OB/GYN’s in multiple cities throughout
Utah. Contact: Physician Recruiting, 800-888-3134, [email protected],
http://physicianjobsutah.org
VIRGINIA
:-6+-2-%
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ER3&+=2TL]WMGMERXSTVEGXMGIMRXLI8MHI[EXIVEVIEQMRYXIW
JVSQXLIFIEGL'EPP'SQTIXMXMZIWEPEV]ERHFIRI½XW
4PIEWIIQEMP':XSKF$KVIIRFVMIVSFLVGS\QEMPGSQ
Recent grads welcome.
3DFNDJH RIIHUV D FRPSHWLWLYH VDODU\ ZLWK FDOO FRYHUDJH %HQH¿WV
LQFOXGH PDOSUDFWLFH LQVXUDQFH KHDOWK GHQWDO . ZHHNV YDFDWLRQ
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Enjoy everything that New England has to offer with this beautiful and
FRQYHQLHQWORFDWLRQOHVVWKDQPLQXWHVIURP%RVWRQ7KLVSLFWXUHVTXH
community is home to some of the best schools in Massachusetts and
provides endless opportunities for cultural, recreational and historical
activities.
Please email [email protected]
CLASSIFIEDS WORKS!
46
CONTEMPOR ARYOBGYN.NE T
Expert Advice for Today’s Ob/Gyn
Content Licensing for Every Marketing Strategy
Leverage branded content from Contemporary OB/GYN to create a
more powerful and sophisticated statement about your product, service,
or company in your next marketing campaign. Contact Wright’s Media to
find out more about how we can customize your acknowledgements and
recognitions to enhance your marketing strategies.
For information, call Wright’s Media at 877.652.5295
or visit our website at www.wrightsmedia.com
JUNE 2016
CAREERS
Expert Advice for Today’s Ob/Gyn
Content Licensing for Every Marketing Strategy
Marketing solutions fit for:
Outdoor | Direct Mail | Print Advertising | Tradeshow/POP Displays | Social Media | Radio & TV
Logo Licensing | Reprints | Eprints | Plaques
Leverage branded content from Contemporary OB/GYN to create a more powerful and
sophisticated statement about your product, service, or company in your next marketing
campaign. Contact Wright’s Media to find out more about how we can customize your
acknowledgements and recognitions to enhance your marketing strategies.
For more information, call Wright’s Media at 877.652.5295 or visit our
website at www.wrightsmedia.com
ADVERTISER INDEX
Companies featured in this issue
To obtain additional information about products and services advertised in this issue, use the contact information below.
This index is provided as an additional service. The publisher does not assume any liability for errors or omissions.
FERRING PHARMACEUTICALS
CERVIDIL ................................... 12-14
www.cervidil7.com
HOLOGIC
NOVASURE ...................................... 5
www.novasure.com
THINPREP ................................ CV2-1
www.thinprep.co
LABCORP
CANCER RISK AND SCREENING .. 3
www.labcorp.com
PRENATAL SCREENING ............... 29
www.labcorp.com
JUNE 2016
LUMENIS
FEMTOUCH.................................... 23
www.lumenis.com
NIGHTLIGHT CHRISTIAN
SNOWFLAKES EMBRYO
ADOPTION ....................... COVERTIP
www.Nightlight.org
THE NORTH AMERICAN MENOPAUSE
SOCIETY (NAMS)
NAMS ANNUAL MEETING ............ 43
PACIFIC WORLD
BIO-OIL ........................................... 35
ZZZSDFLÀFZRUOGFRP
QIAGEN SCIENCES
AMNISURE .................................. CV4
www.qiagen.com
THERAPEUTICS MD
VITAPEARL ..................................... 19
www.vitaMedMDRx.com
www.menopause.org
ONSITE MAMMOGRAPHY
ONSITE MAMMOGRAPHY .............. 9
www.ONsiteMammography.com
CONTEMPOR ARY OB/GYN
47
LEGALLY SPEAKING
by ANDREW I. KAPLAN, ESQ
Did induction cause
this uterine rupture?
A case hinges on the plaintiff’s lawyers claim of departure from good practice.
I
n September 2011, a woman
learned she was pregnant
with her first child and visited ob/gyn Dr A. At some
point during the pregnancy,
Dr A diagnosed fibroids and indicated that if they grew too large, the
patient would need to deliver via cesarean. In the early morning of April
29, 2012, the patient’s water broke
and her husband brought her to the
hospital at approximately 4 am. The
patient—the plaintiff in this case—
was at 35 weeks’ gestation.
Dr A had an agreement with defendant ob Dr B to cover each other’s
patients, and it was Dr. B who was
the attending physician managing
the plaintiff ’s care when she arrived
at the hospital. At the time, Dr B was
the director of ambulatory care as
well. The plaintiff was examined by a
resident upon arrival at 4 am and was
next seen by Dr B at about 5:30 am.
Because the plaintiff had tested positive for Group-B streptococcus (GBS),
Dr B ordered prophylactic antibiotics
and indicated that the plaintiff would
need to be admitted.
At approximately 11:00 am, Dr B
examined the woman and indicated
she would be placing dinoprostone to
prepare the plaintiff ’s nonfavorable
cervix for oxytocin administration later. Dr B then informed the residents
of the examination and placement of
plaintiff to any further infection, Dr B
had instructed that she should be examined only if there was tachysystole,
a FHR tracing abnormality, or active
labor. From approximately 3 pm until
7 pm, the plaintiff was having contrac-
THE PLAINTIFF VAGINALLY DELIVERED
A HEALTHY GIRL WITH APGARS OF 9/9.
the dinoprostone and said that the
plaintiff could receive an epidural if
she complained of pain. At around 2
pm, the plaintiff complained of pain
and an epidural was administered.
Throughout the day, the labor
and delivery nurses monitored the
plaintiff, checking the fetal heart
rate (FHR) monitor and palpating as
necessary at 2:30, 4:05, and 5:43. In
addition, the residents periodically
assessed the plaintiff, but did not perform a vaginal examination as they
were directed not to do so by Dr B
because of the plaintiff ’s GBS status.
Specifically, to prevent exposing the
tions every 2 to 4 minutes, the FHR
tracings were reassuring, and the
plaintiff was not experiencing pain.
Thus, there was no need to conduct a
vaginal examination.
When the plaintiff was examined
by a resident later that evening, the
dinoprostone was found “on the
chux.” No other induction agent was
used and by 8:30 pm, plaintiff was
fully dilated and began to push. At
9:16 pm, the plaintiff vaginally delivered a healthy girl with Apgars of 9/9.
FOR MORE LEGALLY SPEAKING TURN TO
PAGE 40
Andrew I Kaplan, Esq is a partner at Aaronson, Rappaport, Feinstein & Deutsch, LLP in New York City, specializing in medical malpractice defense
and healthcare litigation.
48
CONTEMPOR ARYOBGYN.NE T
JUNE 2016
Published as a supplement to
PUBLISHED AS A SUPPLEMENT TO
X
MAY 2016
X
PREDICTING sPTB EARLY:
WHAT DO WE DO NOW?
MODERATOR:
KIM BOGGESS, MD
Professor of OBGYN, University
of North Carolina
Dr. Boggess has researched and published extensively on the pathophysiology of preterm birth, contributing
to recognition of maternal infection
and periodontal disease as causative
factors. She was a principal investi-
Proceedings of a panel discussion hosted by Sera Prognostics at
the 2016 Society of Maternal-Fetal Medicine Annual meeting.
gator in the PAPR study.
» These two proteins were used in an algorithm which is the ratio of the relative expression levels of two proteins—the ratio of IBP4 over SHBG. This
ratio defines a score used to predict the probability of subsequent preterm
birth.
» Dr. Saade reviewed the performance of these two proteins measured at 19 or
20 weeks of pregnancy as described in the following chart from the paper:
AUC
P-VALUE
OR (95% C)
<35 VS >35
0.93
0.00092
34.5 (1.7-698.9)
<37 VS >37
.75
.016
5.0 (1.4-18.0)
PANELISTS:
MATTHEW K. HOFFMAN, MD
MPH
Vice Chairman, Department of
OBGYN and the Division of
Education and Research,
Christiana Care Health System
(left to right) Jay Boniface, PhD, John Zupancic, MD, Scott Sullivan, MD,
Matt Hoffman, MD and Kim Boggess, MD, discuss the opportunities and
issues related to early prediction of preterm birth at the 2016 meeting of the
Society of Maternal-Fetal Medicine in Atlanta, GA.
X
INTRODUCTION
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Kim Bog gess, MD
SCIENTIFIC OVERVIEW OF THE PRETRM®
TEST FOR RISK MANAGEMENT & THE
PAPR STUDY
BOGGESS: Jay, will you give us an overview of the clinical and scientific
aspects of the PAPR (Proteomic Assessment of Preterm Risk) study?
BONIFACE: Let me begin this discussion by reviewing some of the
highlights of the presentation on the PAPR study given at the SMFM
Oral Plenary session by Dr. George Saade (University of Texas Medical Branch). 2
ABOUT THE PAPR STUDY:
» A large, prospective clinical study of 5501 patients.
» Patients were enrolled across 11 sites in the U.S.
» The participants were representative broadly of the U.S. population
according to race, ethnicity, and geography.
» Serum samples were drawn from women between 17 to 28 weeks
of pregnancy with the intent to identify biomarkers in serum that
would be predictive of women who subsequently experienced a
spontaneous preterm birth (sPTB), defined as birth before 37 weeks
gestation.
» Two proteins were identified that were highly predictive of preterm
birth and can be measured in maternal serum:
› Insulin-like Growth Factor Binding Protein 4 (IBP4)
› Sex Hormone Binding Globulin (SHBG)
Content and funding provided by Sera Prognostics
Dr. Hoffman is an experienced
investigator in OBGYN research; he
is involved in trials nationally and
internationally for the prevention of
preterm birth. Dr. Hoffman was an
investigator in the PAPR study.
The PreTRM Test was developed based on this data; now the physician and the
patient can know her individualized risk of preterm birth.
The test can be performed as early as 19 weeks through 20 weeks, 6 days. We
identified this optimal period as where the test was most predictive. In the future, with continued analysis of these proteins and their trajectories through a
patient’s pregnancy, it may be possible to potentially approximate gestational
age at birth.
SCOTT SULLIVAN, MD, MSCR
Director, Division of Maternal
Fetal Medicine, Medical
University of South Carolina;
Professor, Medical University of
South Carolina
Dr. Sullivan is interested in preterm
birth prevention, OB surgery techniques and the evaluation of health
disparities and quality health indicators. Dr. Sullivan was an investigator
in the PAPR study.
JOHN ZUPANCIC, MD, MS,
SCD
Associate Chief of Neonatology,
Beth Israel Deaconess Medical
Center; Associate Professor of
Pediatrics, Harvard Medical
School
Dr. Zupancic is a neonatologist
and health economist focusing
on performing and improving the
validity of economic evaluations,
and an expert in the use of computer
modeling to determine best practice
when there’s no current evidence or
studies are not possible.
JAY BONIFACE, PHD
Chief Scientific Officer,
Sera Prognostics
Dr. Boniface led the discovery, verification and validation process for
the PreTRM test. His training is in
the area of protein biochemistry, biophysics and molecular immunology.
› Fetal Growth
Restriction
› Androgenic &
Estrogenic
Steroid Levels
› Placental Growth
› Stress
› Nutrient Uptake
› Inflammation
The majority of preterm births may be explained by a model that postulates that
pregnancies associated with infection/inflammation or placental insufficiency would
be expected to result in suppressed SHBG or elevated IBP4 levels, respectively.
CLINICAL IMPLICATIONS OF AN
OBJECTIVE PREDICTOR OF PRETERM BIRTH
BOGGESS: Matt and Scott, could you discuss what you think the implications
are of having this information clinically as you see women in your practice?
HOFFMAN: First, let me state that we have a great history of examining protein expression in obstetrics to predict risk. One example is the quad screen,
that by examining proteins that are differentially expressed in a specific time
frame, we can meaningfully assess the risk of a pregnancy being affected by
Down syndrome. This is not a novel model for obstetrics.
Regarding prematurity, when we look at the cost and implications on obstetrical care, prematurity remains our primary challenge. Meaningful change has
not been made as of yet. This is in large part due to the fact that until recently,
we have been unable to reliably identify which women are at risk. Now that we
have the PreTRM test, what do you do with the results and how do we make
this clinically meaningful?
Content and funding provided by Sera Prognostics
Predicting sPTB Early:
What Do We Do Now?
A panel discussion on spontaneous preterm
birth hosted by Sera Prognostics
read it now at
contemporaryobgyn.net/sera-sptb
based on physical examination alone (1). And traditional
diagnostic methods* carry a combined negative predictive
value (NPV) of 54.5% (2).
AmniSure is a 98.9% sensitive, 98.1% specific test
for PROM. AmniSure can be run within 10-15
minutes and does not require a speculum
exam (3).
To learn more, visit
www.AmniSure.com
*ph/nitrazine, ferning, pooling.
Trademarks: QIAGEN®, Sample to Insight®, AmniSure® (QIAGEN Group).
PROM-9498-001 03/16 1101407 © 2016 QIAGEN, all rights reserved.
Sample to Insight
Membranes) Test Instructions for Use. QIAGEN, 2015.
Membrane (PROM) cases, the diagnosis is uncertain
E.R., Kim, K.W., Park, H.S., Jun, J.K. (2007) Measurement of placental a-microglobulin-1 in cervicovaginal discharge to diagnose rupture of membranes. Obstet. Gynecol. 109, 634–40. AmniSure ROM (Rupture of [fetal]
In nearly half of all suspected Premature Rupture of
References: 1. Neil, P.R.L. and Wallace, E.M. (2010) Is AmniSure useful in the management of women with prelabour rupture of the membranes? Aust. N. Z. J. Obstet. Gynaecol. 50, 534–8., 2. Lee, S.E., Park, J.S., Norwitz,
Your answer can
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