Use of oral vs vaginal Misoprost following mifepristone(200mg) for second trimester abortion

Abstract               Background: Various medical methods for second trimester medical termination of pregnancy exist, which includes misoprostol alone oral or vaginal and combination of both mifepristone and misoprostol. Misoprostol following mifepristone can be given both vaginally and orally. this study is a comparison between oral and vaginal route of misoprostol after cervical priming with mifepristone. Method: this was a prospective comparative study of mifepristone(200mg) +oral misoprostol and mifepristone(200mg) +vaginal misoprostol for second trimester MTP(14 -20weeks).20 patients received mifepristone (200mg) followed by oral misoprostol(400mcg) and 20 patients received mifepristone(200mg) followed by vaginal misoprostol(400mcg).upto a maximum of three doses of misoprostol were used. in both groups oxytocin infusion were started if abortion did not occur. efficacy of oral versus vaginal misoprotol, induction-abortion interval and need for surgical intervention were analysed. Results: both groups were well matched in terms of age, parity, mean gestational age and indication for MTP. the overall induction abortion interval in group A(oral misoprostol) was 10.6 hours where as it was 8.23 hours in group B(vaginal misoprostol).complete abortion was achieved in almost 100% cases. only 3 case required check curettage for retained product as diagnosed by ultrasonography. Conclusion: though both oral and vaginal misoprostol are effective and safe method of abortion. vaginal route appears to be more efficacious for 2nd trimester.

Key Word: misoprostol, mifepristone, induction-abortion interval, second trimester MTP, curettage.

INTRODUCTION

Medical termination of pregnancy Act (MTPAct) has liberalised indications for which abortion is legal in India and incidence of abortion has declined due to improved access to conception, the availability of ultrasonographic diagnosis of fetal abnormalities tends to increase the incidence of abortion in 2^nd trimester. 2^nd trimester MTPs account for 250% of all MTPs. All 2nd trimester MTPs should take place in health care facility as there is risk of bleeding and infections. This study deals with the use of Misoprst, a synthetic prostaglandin analogue for this purpose. This study is a comparison between oral and vaginal routes.

METHODS

It is a prospective study done in JLNMCH Bhagalpur between June 2018 and to Dec 2018 (6months).

Aim of the study was-

1.  To study the efficacy of Oral versus Vaginal Misoprost for 2^nd trimester abortion.
2.  Induction – abortion interval (I-A) by both routes.

Inclusion criteria:

1. All patients irrespective of marital status with 14 – 20 weeks of gestation.
2. With single live intrauterine fetus seeking abortion abortion services.
3. For valid indication under MTP Act.
4. Age 18-40 yrs.

Exclusion criteria:

1. Patient with multiple pregnancies.
2. Intrauterine device in situ.
3. Intrauterine  foetal  death
4. Hb  < 8.5 gm %
5. H/O major medical illness.

Detailed history, physical examination and confirmation of pregnancy by clinical examination and ultrasonography, Hb% and ABO Rh. Indication for MTP noted and consent for MTP was taken in standard MTP form. Study consent was taken from all patients. 20 patients were given oral Misoprost and 20 patients were given Vaginal Misoprost. Both groups received Milfepritone (200 Mg) 36 hours prior to Misoprost. Both group received 400mcg Misoprost 4 Hrly 3 doses. Oral group swallowed the tablet with water. Vaginal group received 400 mcg of Misoprost premoistened with normal saline inserted vaginally in the post fornix under aseptic precautions. Patients in both groups were monitored 4 hourly to determine the need for further dose. Study end points were – “complete abortion” which was defined as complete expulsion of abortus ensac / abortion along with placenta with no product of conception retained in the uterus on bimanual examination. Check curettage was indicated in case of incomplete abortion. , 20 units of Oxytocin were started in 500 Ml of Ringer’s Lactate till abortion occurred. During abortion on process suitable analgesics were used as per the need of both groups. ‘Efficiency’ was analysed on the basis of complete abortion, total number of doses of misoprostol required, need for augmentation with oxytocin, need for check curettage in case of incomplete abortion. Patients were monitored for 24 Hrs post abortion for complications after which they were discharged. Comparison between 2 groups were done by Chi Square test, Pearson’s Chi-Square test, Fisher’s exact test. A total of 40 patients (20 in each groups were studied).

Table 1:

Table 2: Inclusion Abortion interval and Misoprost requirement (Calculated  from the time of insertion of  I^st  dose of Misoprostol ) I-A.

Unpaired t test p <0.05(significant); chi square test p<0.05(significant)

RESULT

A total of 40 patients were studied. Maternal characteristics are shown in table -1. Majority of the cases were in the age groups 18-32 Years in both the groups. 15% of patients in oral group and 20% of patients in vaginal group were primigravida.60% 0f patients in oral group and 65% of patients in vaginal group had no history of previous abortions. Maximum number of patients in both age groups had fetus with gestational week 16 wks 01 days to 18 weeks. Unawareness, failure of contraception were the major indication for Medical termination of pregnancy in both the age groups. Congenital malformations and social factor were other reasons. In oral group <80% patients aborted in <16 Hrs whereas > 95% patients aborted before 16 hours in vaginal group. The overall mean I-A interval in group A(Oral) was  10.6hours whereas it was 8.23 hours in group B (Vaginal).

Table 3:

The overall mean number of doses was 1.7 hour in oral group where as overall mean number of doses in vaginal group was 1.45 hour respectively. This difference was also statistically significant with p value test than (p < 0.05). Complete abortion was achieved in almost 100% cases, both vaginal and oral route following Mifepristone 200 Mg used for priming as suggested by RCOG guidelines (Royal College of Obstetrician and Gynaecologists). Check curettage was done in 3 cases for retained product as evidenced by follow up ultrasonography 1 in group   B (vaginal route) and 2 in group A (Oral route).

DISCUSSION

In our country the liberal MTP Act has unfortunately been misused for second trimester termination of pregnancy following sex determination and has been wrongly related to the PC-PNDT Act. Due to legal implications and close monitoring by authorities many practitioners may even refuse to perform second trimester MTP, even when indicated. As a result of which the cases of 2^nd trimester abortion has increased in government hospitals.  The introduction and availability of drugs which can cause mini labour have revolutionised the performance of pregnancy and emphasis is less on surgical techniques and more on administration of Mifeprestone and Misoprostol. We had five patients (3 in group A and 2 in group B) who were < 20yrs of age. Majority of Patients were 2^nd Gravida. Increased parity reduces the time for expulsion of fetus in MTP. A similar study by Bengal et-al analysed 148 women seeking MTP over a period of 3 years. They used an initial dose of 400 mcg. of Misoprost by vaginal route followed by 200 mcg every 4 hours till maximum of six doses. Overall success rate was 92% where as it is 100% in this study in which Mifepristone (200 Mg) has been used for primining prior to the use of vaginal or oral Misoprost.

CONCLUSION

To conclude 400 mcg Misoprost 4hourly by oral or vaginal route following 200mg of Mifepristone 36 hours prior is very safe for 2^nd trimester MTP. Vaginal route appears to be more efficient with an overall induction – abortion interval of 8.23 hours following 1^st dose of Misoprost (400Mg) where Mifepristone was given orally 36 hours prior to induction.

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