INTRODUCTION:
Mid trimester termination of pregnancy is one of the controversial
issues in obstetrics and gynecology which has moral, technical,
emotional and social issues. Many Indian women opt for MTP (Medical
Termination of Pregnancy) in second trimester inspite of increased
morbidity like excessive hemorrhage, uterine perforation and infection
because of unplanned pregnancies. In addition, there is a continuous
need for termination of pregnancy in second trimester as there are
advanced antenatal diagnostic tests which enable us to identify lethal
fetal anomalies.
Termination of pregnancy in second trimester is associated with
much more morbidity and mortality than when it is done in the first
trimester. The various methods for second trimester termination of
pregnancy are still under scrutiny and the search for the ideal method
which is the safest, easiest, cheapest and optimally most effective is still
going on.
Second trimester pregnancy termination can be carried out by
both medical and surgical methods. Medical methods are comparatively
safer and have superseded the surgical methods because of risks
involved in surgical methods.
AIMS AND OBJECTIVES:
1. To compare the abortifacient efficacy of vaginal misoprostol
with mifepristone and vaginal misoprostol alone in second
trimester pregnancy termination.
2. To compare the induction -abortion intervals.
3. To compare side effects and complications.
4. To compare the Cost effectiveness.
5. To identify the suitable method for second trimester MTP by
comparing the various parameters.
MATERIALS AND METHODS:
This study comparing the efficacy of mifepristone – vaginal
misoprostol combination with vaginal misoprostol alone as a method of
second trimester abortion conduct at Institute of obstetrics and
Gynaecology, Chennai – 08 during October 2009 – October 2010.
Study design: Prospective randomized comparative study.
Study Place : Institute of obstetrics and Gynaecology, Chennai-8.
Collaborating Unit : Department of family welfare, IOG.
Study Population : Patients requesting abortion in their second trimester
at Department of family welfare, IOG and patients
requiring abortion at second trimester at IOG, Egmore.
Period of Study : OCT2009 – OCT2010.
Sample Size: 100 (Randam allocation to either group),
50 – mifepristone + vaginal misoprostol group,
50 – vaginal misoprostol group.
Inclusion Criteria: 14 – 20 weeks gestation, Woman full filling the MTP indicators
as per the MTP act ,Single live fetus, Present with closed cervical os, No vaginal bleeding and Patients consenting to this procedure only.
Exclusion Criteria : History of previous uterine surgery (but not a contraindication),
Known allergy / Contraindications to mifepristone (or misoprostol / prostaglandin), Multiple fetus, Intra uterine fetal demise, Presentation in active labour, Low lying placenta.
SUMMARY:
1. One hundred Patients opting for second trimester pregnancy
termination or diagnosed to have anomalous fetus were
considered for the study. Fifty patients received 200mg
Mifepristone ,followed by 800mcg vaginal misoprostol 36 hours
later, followed by 400mcg vaginal misoprostol every 3 hours
interval of maximum 4 doses or until delivery. In another fifty
women, 800mcg vaginal misoprostol followed by 400 mcg
vaginal misoprostol every 3 hrs interval of maximum 4 doses or until delivery.
2. The two groups were comparable with respect to maternal age,
parity and gestational age at the time of induction of abortion.
Majority of patients in either group were in the age group of 21-
25 years. The commonest gestational age in both group was between 17-18 weeks.
3. There were more multigravida than primigravida in both the
groups. Induction abortion interval in primigravida is more
compared to multigravida in both group and it was statistically
significant in Mifepristone and misoprostol combination (pvalue.01).
4. The most common indication for pregnancy termination in both
group was unwanted pregnancy due to social reasons.
5. Induction abortion interval in Mifepristone and misporstol group
was 8.2 hours and that in misoprostol alone group was 12.8
hours.The difference between them was found to be statistically
significant (p value 0.000).
6. According to the gestational age, induction abortion interval was
not statistically significant in both groups.
7. The percentage of complete abortion in Mifepristone and
misoporostol group was 90% and in misoprostol group was 72%
but the difference was not statistically significant. The percentage
of incomplete abortion was 10% in Mifepristone and misoprostol
group and was 24% in misoprostol alone group which did not
reach statistical significance.
8. There was no failure in Mifepristone and misoprostol group and
4% in misoprostol alone group, but it was not statistically
significant. The complete abortion rate within 12 hours was 76%
in Mifepristone and misoprostol group and 36% in misoprostol
alone group and in 24 hrs it was 100% and 96% respectively.
Additional intervention needed in Mifepristone and misoprostol
combination group was 10% and in misoprostol alone group was
28%and most common being instrumental evacuation.
9. The mean dose of misoprostol used was 1376 mcg and that of
misoprostol group was 1992 mcg.
10. The average cost in misoprostol alone group was rupees 194.2
and Mifepristone and Misoprostol combination group was rupees
483.1, which is two times higher.
11. There was no statistically significant side effects between two
groups and no major maternal complications found in both group.
12. It was observed that no bleeding (or) abdominal pain (or) any
adverse reactions were not reported after administration of
Mifepristone prior to vaginal Misoprostol administration (36
hrs). so Mifepristone could be administered safely prior to
hospital admission for termination.
CONCLUSION:
Comparing Mifepristone and Vaginal misoprostol combination
with vaginal misoprostol alone for second trimester pregnancy
termination, it was observed that,
Mifepristone with vaginal misoprostol combination group
is associated with shorter induction abortion interval and
100% success rate. The complete abortion rate , success
rate and side effects were comparable in both group.
Vaginal misoprostol alone group also dosen’t have the 36
hours anxiety/unease from the time of mifepristone
administration.
Vaginal misoprostol alone group is cost effective.
Hence vaginal misoprostol alone group can also be
considered as an effective alternative for Mifepristone and
vaginal misoprostol combination group