Medical abortion
offers an important alternative to surgical abortion for women with
early pregnancies who wish to avoid a surgical procedure.technologies.surgical
procedure. AIIMS has been conducting research on medical abortion
since initiation in 1970s for development of a medical method of
terminating pregnancy. The programme of research began by testing
the use of prostaglandins alone. The prostaglandin compounds available
at that time (sulprostone, gemeprost and meteneprost) were effective
only at such high doses that they produced unacceptable side-effects.
When the antiprogestin, Mifepristone became available in early 1980s,
researchers found that it was not effective when used alone. When
used in conjunction with sulprostone, gemeprost or misoprostol,
it showed great promise as an alternative to surgical abortion.
The standard sequential regimen nowadays is 200 mg mifepristone
(up to seven weeks pregnancy) followed 36 to 48 hours later by two
200 µg tablets of misoprostol or 1 mg gemeprost vaginal pessary.
Research Projects undertaken at AIIMS include:
1. Comparative study of different prostaglandins as abortifacients
for termination of late pregnancy between 16 to 20 weeks in the
year1975. Intraamniotic PGF2a 40mg versus 15 methyl PGF2a 25 mg
intramuscular versus extraamniotic 15 methyl PGF2a 50µg had
a success rate of 85%, 100% and 96% respectively and a nearly similar
induction abortion interval of around 18 hours.
2. Comparative study of Sulprostone 500 µg (Prostaglandin
analogue) followed by 1000 µg 4 hours later versus vacuum
aspiration for termination of early pregnancy (35-45 days) in 40women
in 1983 had a success rate of 85% and 100% respectively.
3. Comparative study of methods of pre-abortion cervical ripening-isaptent,
laminaria and intramuscular PGF2a for termination of early pregnancy
(POG 8 to 12 weeks) in 1983. Mean cervical dilatation achieved with
isaptent, laminaria and intramuscular PGF2a was 10.15 mm, 10.25
mm and 10.10 mm respectively.
4. A WHO multicentric trial in 1989 used mifepristone and sulprostone
combination for termination of early pregnancy up to 49 days gestation.
Total 251 women were recruited, 40 from India. They were divided
into 2 groups. Group I received mifepristone 25 mg b.i.d for 3 days,
Group II received mifepristone 25 mg b.i.d for 4 days. Both groups
received injection sulprostone 250 µg on D3.
5. A WHO multicentric, randomized, double blind, placebo controlled
trial using three misoprostol regimens after pre-treatment with
mifepristone for termination of pregnancy up to 63 days from 1998-
2000. Success rate was nearly 96 to 98% in all the groups.
6. Comparative study of vaginal misoprostol 800 µg single
dose versus intraamniotic prostodin (15 methyl PGF2 a 2.5 mg for
termination of pregnancy between 14 to 20 weeks (2001-2002). Complete
abortion rate within 48 hours was 97.5% and 75%, induction abortion
interval 16.3 and 21.3 hours for misoprostol and intraamniotic prostodin
respectively.
7. Cervical ripening with sublingual misoprostol 400 µg versus
placebo in early pregnancy (6 to 11weeks) prior to surgical evacuation
(2002). Mean cervical dilatation achieved was 7.7 mm and 3.4 mm
with misoprostol and placebo respectively.
8. Comparative study of sublingual versus vaginal misoprostol 400
µg for cervical ripening in early pregnancy (6 to 11 weeks)
prior to surgical evacuation (2002). Mean cervical dilatation achieved
with vaginal and sublingual misoprostol was 6.8 mm and 8.6 mm, respectively.
Besides completed studies several other research trials on medical
abortion are being conducted or planned to be carriedout at AIIMS
(Table 5.2.1)
Main outcome measures being evaluated are effectiveness of the
procedure (i.e. complete medical abortion without surgical intervention),
adverse effects, acceptability of the procedure based on patient
questionnaires, reasons for surgical intervention and adverse outcomes
compared among the study groups.
Overall analysis of acceptability in these studies showed that
nearly 97% of the Indian women found the medical methods highly
acceptable, but most (86%) opted for hospital administration only,
6% for home administration and the remaining were indecisive.
For medical methods of abortion to work successfully, women must
feel committed to completing the regimen, and both women and providers
must wait while therapy takes its course.
Table
5.2.1
WHO multicentre abortion studies with AIIMS participation |
Project A05217 : Comparison
of two routes (sublingual and vaginal) and two intervals of
Misoprostol for termination of early pregnancy
Project A15065 : A double blind randomised
comparison of two misoprostol-regimens (sublingual and vaginal)
in termination of pregnancy in the second trimester
Project A15066 : Pretreatment with misoprostol
before vacuum aspiration for first trimester induced abortion
: a multicentre double blind randomized controlled trial
Project A15078 : Comparison of two mifepristone
doses and two intervals of misoprostol administration for
termination of early pregnancy: a multinational randomized
controlled trial
Project A25026 : Incidence and risk factors
for Pelvic Inflammatory disease (PID) following induced abortion
: a multicentre nested case control studies
NEW PROJECTS IN PIPELINE
Project A25121 : Comparison of medical
and surgical methods to evacuate the uterus in women with
a non-viable pregnancy up to 12 weeks of gestation : a randomized
multicentre trial
Project A35148 : Comparison of four different
misoprostol regimens after pre treatment with mifepristone
for early pregnancy termination |
|