Medical abortion

Transcription

Medical abortion

An update on medical abortion
Kristina Gemzell Danielsson, prof, MD, PhD
Director of the WHO CCR in Human Reproduction
Reproduction,
Chair, Division of Obstetrics & Gynecology,
Department of Women
Women‘ss and Children
Children‘ss Health
Health,
Karolinska Institutet / Karolinska University Hospital
Stockholm Sweden
Stockholm,
"Women are not dying because of diseases we
cannot treat. They are dying because
societies
i ti
have
h
yett to
t make
k the
th decision
d i i
that
th t
their lives are worth saving.
saving.”
Professor M.F. Fathalla
F
Former
President
P
id t off th
the International
I t
ti
lF
Federation
d
ti
off G
Gynaecology
l
and
d Ob
Obstetrics
t t i
Professor of Obstetrics and Gynaecology, Assiut University, Egypt
Increased access to safe abortion. K.Gemzell
Causes of maternal deaths in developing regions ( %)
~50,000
,
- women's deaths
~ 5 million temporary or
Permanent disabilities
Huge financial and social
C t tto women, their
Costs
th i
families, and
health systems
Shah, 2009; Vlassoff, 2008)
The Millennium Development Goals Report 2010
The vast majority
j y of these deaths are avoidable
http://www.un.org/millenniumgoals/pdf/MDG Report 2010
Who decides over fertility?
US-president Bush signing a law against late abortions, 2003
The link between contraceptive prevalence and abortion
Levels of use of modern contraception and abortion rates
countries with total fertility rate between 1.7 and 2.2.
Contraception for young and ulliparous women, K.Gemzell Danielsson
WHO; Progress in Reproductive
Health, 2003
Abortion related deaths can be p
prevented !!!!
•
Recognize abortion as a major contributer to maternal mortality
– Politicians, doctors, nurses (FIGO), the Church etc.
•
Increase access to safe abortion methods and stop
p outdated
methods- Vacuum aspiration (MVA), medical abortion, misoprostol,
”menstrual regulation”
regulation”, PAC
•
Increase emergency service för abortion related complications
– Midlevel providers, doctors, MVA, drugs
•
Contraceptive councelling and contraception also for young and
unmarried women
•
Information on sexual and reproductive health and rights
•
Empower women!
Development of medical abortion. K.Gemzell
Development
p
of medical abortion
•
70ies, Prostaglandin analogues, High efficacy, High incidence of side effects
•
80ies Mifepristone (RU 486
80ies,
486, Roussel Uclaf
Uclaf,
Bygdeman & Swahn 1985
Prof. Etienne Baulieu),
60 80 % efficacy Herrman et al., 1982, Kovacs et al., 1984
60-80
•
1985; Mifepristone increases uterine
contractility
t tilit and
d sensitivity
iti it tto PG
•
1986 Mife+ Gemeprost Cameron, Michie, Baird
•
1991 Mife+ oral misoprostol Norman,Thong, Baird
•
1995 Vaginal misoprostol more effective than oral
•
Medical abortion mifepristone followed by PG:
1988 France
1991 UK
(1992 Chi
China
1992 Sweden
El Rafaey…,Templeton
49d., 400 mg Cytotec®
63d. 1mg gemeprost
49d 600 mg C
49d.,
Cytotec®)
t t ®)
63d.,1mg gemeprost Development of medical abortion. K.Gemzell
Source: national abortion statistics, MUVS, Vienna,
I
Impact
t off reducing
d i
barriers
b i
in
i access
Official statistics of Sweden, Induced abortions 2007
Medical abortion is one of the safest
medical
di l procedures,
d
with
ith minimal
i i l
y and a negligible
g g
risk of death.
morbidity
Increased access to medical
abortion can lead to a decline in maternal morbidity
and mortality
Risks of medical abortion in perspective:
p
p
Mortality unsafe abortion is 1 : 450
Mortality of an early medical abortion is < 1 : 500
500.000
000
Mortality of giving birth in Europe 1 : 20.000
Estimated road traffic death rate in Europe 1 : 25.000
Early abortion; surgical vs.
vs medical
O t
Outcome
M di l (%)
Medical
S i l (%)
Surgical
Complete
abortion
H
Heavy
bleeding
Infection
96-99
96
99
98
0103
0.1-0.3
11
1.1
0.03
0.9
-
02
0.2
Mechanical
M
h i l
injury
Ulmann et al., acta obstet Scand 71:278, 1992, Friedman et al., Am J Pub Health 76:550, 1980
RCOG 2004
Aktuellt om medicinsk abort, K Gemzell Danielsson
Medical abortion
Mifepristone
• Mifepristone - alone is not sufficiently effective (60-80%)
• Mifepristone primes the cervix
cervix, increases contractility and
increases the sensitivity of the myometrium to PG
• Non-linear pharmacokinetics. Low side effects
• Provided the dose is enough for priming of the cervix and
the myometrium –increasing
increasing the dose doesn't increase
efficacy and cannot compensate for an insufficient
prostaglandin analogue/ dose/ route
Medical abortion to 63 days, K.Gemzell
What is Misoprostol?
•
An orally active prostaglandin E1 analogue
•
Induces uterine contractions and cervical softening
softening,
•
Acts very fast
•
Non toxic
•
Misoprostol has several advantages over the other
prostaglandins
p
g
((safer, stable at room temperature,
p
oral/vaginal application, cheaper)
•
M k t d iin 1985 and
Marketed
d approved
d iin >90 countries
ti
•
Has the p
potential to reduce maternal mortality
y
Prevention of unsafe abortion. K.Gemzell
Medical abortion
Mi
Misoprostol
t l
• Misoprostol
Misoprostol– alone highly effective
• Side effects mild and dose dependent
• Priming with mifepristone increases efficacy, allows lower
dose and less side effects
• Route of administration more important than the dose
• Oral misoprostol is not effective beyond 49-56 days.
Cannot be compensated for by:
– An increased dose of mifepristone
– An increased dose of oral misoprostol
– Repeated doses of oral misoprostol
Medical abortion
Recommended regimen up to 63 days
Recommended by WHO, RCOG, FARG:
mifepristone 200 mg +
misoprostol 800 mcg vaginally
A repeated dose of 400mcg misoprostol p.o after 3-4h if needed
Why
y is oral administration less
effective?
Oral vs. vaginal misoprostol
Zieman et al. 1997
Registration
g
of
uterine contractility in early pregnancy
Effect on Uterine Contractions
Gemzell Danielsson et al., 1999
Repeated doses of misoprostol
misoprostol vaginally
•
200 mg
g mifepristone
p
+ 800 mg
g misoprostol
p
vaginally
g
y
•
Up to 63 days of gestation
•
2 000 consecutive abortions
2.000
•
98% efficacy
Ashok et al.,Hum Reprod 1998
•
Following
g 2.000 cases treated with an additional dose of 400mcg
g
misoprostol if no bleeding in 4h
•
Increased efficacy
efficacy, influence of pregnancy length disappeared
Ashok et al., 2002
Interval mifepristone-misoprostol
• 200mg mifepristone + 800 mcg misoprostol vaginally:
24h as effective as a 48h interval
WHO 2007
Pain prophylaxis
• Diclofenac 100 mg and Parcetamol
co-administered
d i i t d with
ith misoprostol
i
t l
• NSAID does´t
does t affect
uterine contractility,
cervical ripening or
th induction-to-abortion
the
i d ti t b ti iinterval
t
l
www.who.int/reproductive-health/publications/safe_abortion/safe_abortion.html
Induced
d
d second
d trimester
ti
t abortion
b ti
sugical vs medical abortion
•Specialized
p
training
g and the maintenance of an
adequate caseload are required to perform D&E
safely.
safely
“The appropriateness of D&E as a method of
g second-trimester p
pregnancy
g
y is
terminating
questionable when safe and effective medical
alternatives exist”
exist
Report of Confidential Enquires into Maternal Deaths (UK 1994–1996);
2012 Update of Updated WHO guidance on safe abortion
•
Emphasizes the simplifying or streamlining of abortion care,
•
N t a high
Notes
hi h value
l on research
h tto demedicalize
d
di li abortion
b ti care
•
Affirms that home use of misoprostol is a safe option for women
Th Guidance
The
G id
suggests the
h evaluation
l i off iinternet provision
i i and
d
telemedicine, as further alternative service delivery channels of
safe abortion, as a subject for future research
Simplifying medical abortion
I
Increasing
i Access
A
to
t Safe
S f Abortion
Ab ti
S
Services
i
Medical abortion
•
Highly effective, safe and acceptable method
•
Can be used for all gestational lengths
•
Can replace surgical abortion
•
Mifepristone –
Limited approval
Available in about 60 countries
Expensive
Misoprostol– alone highly effective
But priming with mifepristone increases efficacy, allows lower dose
and less side effects
How can we increase access
to medical abortion
with the most effective regimen?
1 H
1.
Home use off ((mifepristone)
if i t
) + misoprostol
i
t l
2. Telemedicine
3. Task - shift / - sharing
4 Simplified procedures for FU
4.
1. Home use of misoprostol up to 63 days
 Safety and acceptability established in a number of studies
•
Reasons to choose home-use of misoprostol
– Easier,, More private
p
– Feels more comfortable with a heavy bleeding at home
•
H
Home
use an option
ti iin S
Sweden
d since
i
2004
(approved by the Board of Health and Welfare)
•
99 % would have p
preferred to take mifepristone
p
at home
Fiala et al., 2004, Kopp-Kallner et al., 2010
•
g outpatient
p
medical abortion services through
g 70 days
y of
Extending
gestational age.
Winikoff B, et al.,. Obstet Gynecol. 2012 Nov;120(5):1070-6.
2. Medical abortion at home
up to 63 days
• www.womenonweb.org
b
• Telemedicine service (English,
(E li h S
Spanish,
i h P
Portugese,
t
F
French,
h P
Polish)
li h)
• Online consultation with a medical doctor
• Medical abortion conducted by
y internet/ email
• April- Dec. 2006
• 484 women; 80% up to 49d.,
• In 79% gestational length confirmed by US
www.womenonweb.org
g
3 T
3.
Task
k sharing:
h i
Medical
M di l abortion
b ti
provided
id d
by physician or midwife
•
RCT to assess the feasibility and acceptability of medical abortion
up to 63 days' gestation when used in clinical routine
•
provided by either midwife or gynecologist
•
T i i prior
Training
i tto th
the study
t d iincll b
basic
i kknowledge
l d on iinduced
d
d abortion,
b ti
knowledge on ultrasound examination and treatment regimens,
theoretical and practical)
Kopp Kallner H, Gomperts R,Johansson,M, Salomonsson E, Marions L, K Gemzell-D
BJOG. 2014 Jul 18.
Medical abortion provided by
physician or midwife
Earlier study; Midlevel provision of medical abortion:
•
Midlevel provision of medical abortion in Nepal – no difference
in efficacy compared with physician
Warrener I et al., Lancet 2010
Main differences:
•
N pre-selection
No
l ti off patients,
ti t Randomised
R d i d att b
booking
ki
•
Examination incl. gynecological ultrasound
•
Home use of misoprostol allowed
Results equivalence trial
Results,
•
1075 women treated (1180 patients randomised (2011-2012))
•
17 (17/940, 1.8%) of patients had a vacuum aspiration:
5 (5/481
(5/481, 1%) in
i the
th nurse midwife
id if group and
d 12 (12/459
(12/459, 2
2.6%)
6%)
in the
ep
physician
ys c a g
group.
oup
•
Equivalence for efficacy was established.
•
There were no significant differences in safety parameters.
Results
•
No differences were found with regard to:
– Demographic
D
hi parameters
t
– Acceptability
– ”How well informed”
– ”Feeling safe”
– Numbers of unscheduled visits or surgical interventions
4 Follow up: routine vs.
4.
vs self assessment
Rational
•
L
Low
rate
t off FU after
ft medical
di l abortion
b ti
•
FU may lead to unnecessary interventions
•
Only reason for FU to detect an continuing viable pregnancy
•
F il
Failure
rates ((early
l MA) 1/1000
•
s-hCG most effective, several limitations (acceptability, costs,
logistics..),
•
s-hCG
hCG shows
h
good
d correlation
l ti with
ith u-hCG
hCG
•
High sensitivity u-hCG positive in most women at 2 -3 weeks FU
Follow up: routine vs. self assessment
•
Objectives. To evaluate self-assessment using a low sensitivity
u-hCG test (DUO-test) at home
•
and telephone FU
•
after medical abortion versus routine FU in the clinic
•
in medical abortion up to 63 days' gestation with home miso
•
q
Additional questions:
•
Is the test easy to use?
•
Do women prefer one-stop treatment compared to hospital FU?
Home self test
Complete abortion
Incomplete abortion
or failed test  'Call the Clinic
Checklist MA Home Assessment
Check the box when the answer is YES
Complete abortion (when 2 or more ):
 Did you see expulsion of products?
 If you had any pregnancy symptoms before
before, are they gone?
 Did the pregnancy test (1000) show negative?
Incomplete abortion/complications (when 1 or more ):

 Are you still bleeding?
 If yes, more than a normal period?
 Do you have severe abdominal cramps?
 Did the pregnancy test (1000) show positive?
 Do yyou feel sick?
 Have you had a fever?
 Have you had prolonged abdominal pain?
 Do you have excessive blood loss?
 Do you feel weak/ the whole body is aching?
Contact
the clinic
Assessment of the outcomes
• Telephone FU by nurse/midwife within 1 month to evaluate
success and satisfaction
• All patient records reviewed at 3 months to control for any
abortion related complications
Results
•
No difference in demograph
demography
•
Median gestational length 6 (4-9) weeks
•
Group 1: FU at 2-3 week at outpatient clinic/hospital; 466
women
•
Group 2: Assessment of complete abortion at 1-3 weeks by
women themselves using the DuoTest: 458
women.
Results
•
No difference in efficacy or safety
•
Within three months after the abortion, the rate of women having
complete abortion and no need for surgical treatment or additional
p
misoprostol:
•
Group 1:94% and Group 2: 95%. Crude risk difference (95% CI) for home
self-assessment vs standard outpatient FU -1.0 (-4.0-2.0). p 0.513
•
Rate of surgery was 4% in both groups
•
Two ongoing pregnancies in Oslo and one in Helsinki, all in the Home
group, initially
i iti ll undiagnosed
di
db
by th
the patients
ti t
Results
•
91% found the semi-quantitative urine hCG-test easy to use.
•
No difference in telephone calls or extra visits (p=0.479)
•
Significantly more women were lost to FU in the control group
(29%) vs. the intervention group (1%) (p<0.001)
•
82% in the intervention group preferred self-assessment vs.
59% in the control group in case of a future abortion (p<0
(p<0.001).
001)
Conclusions
Women are able to safely have a medical abortion with home use of
misoprostol
i
t l 63 d
days off gestation
t ti and
d self
lf assessmentt off the
th
outcome of the treatment using a low sensitivity urine hCG-test.
Self assessment is resource-saving. A step in demedicalising
abortion and women prefer it
Women need to be counseled that self-assessment enyails a risk of
an undiagnosed ongoing pregnancy. Any introduction of selfassessment will need a careful evaluation of the test as well as of
user performance
Medical abortion; ”one stop clinic”
Karolinska University Hospital 2012
•
Telefon booking
g
•
Visit 1 on Day 1 to midwife or gynecologist;
couseling, examination, contraceptive provision
•
p
taken in the clinic
Mifepristone
•
24-48 h later: Cytotec at home, pain medication
•
FU at 1- 2 weeks. u-hCG (1000 IU) self test and checklist
•
Women can chose between:
–
surgical or medical abortion
–
misoprostol at home or in the clinic
–
FU in the clinic or self assessement
C
Conclusion
l i
Access to effective contraceptive methods and safe abortion
are prerequisites for Reproductive Health
•
"Preventing unsafe abortion is the greatest public health and human rights
challenge of our times“
times . "Reaching
Reaching MDG5 will be impossible without
addressing unsafe abortions“
“
The evidence shows that women who seek an abortion will do so regardless
of legal restrictions. …
Where there are few restrictions on the availability of safe abortion
abortion, deaths
and illness are dramatically reduced."
Women and Health: Today's Evidence Tomorrow's Agenda (WHO, 2009)
Conclusion cont.
cont
Increased access to safe induced abortion may be achieved
through medical abortion
Next Congress of
ESC
European Society for Contraception and Reproductive Health;
2nd world conference on Contraception
BASEL May, 2016
FIAPAC
International Federation for providers of
abortion and contraception
Lisbon Oct. 2016

Medical abortion

Transcription

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