Two regimens of vaginal misoprostol in second trimester termination of pregnancy – a prospective randomised trial

KUMAR BHATTACHARYYA, SUBIR
MUKHERJI, JOYDEB
SANKAR KAMILYA, GOURI
RAY, SAILESH
HAZRA, AVIJIT

¹Department of Obstetrics and Gynecology, R.G. Kar Medical College and Hospital, Kolkata, – 700 004, India
²Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, – 700 020, India

Correspondence to: Subir Kumar Bhattacharyya, A1/4, Bidhan Abasan, FB Block, Sector III, Salt Lake, Kolkata, – 700 097, India [email protected]

(Received 21 March 2006; accepted 18 April 2006)

Acta Obstetricia et Gynecologica Scandinavica 85(12):p 1458-1462, December 2006. | DOI: 10.1080/00016340601002282

Abstract

Background.

The search continues for a safe, effective, and cheap method for mid-trimester termination of pregnancy. Misoprostol is a strong contender in this respect. The dose schedule of misoprostol is still not fixed. The objective of our present study was to compare the efficacy and adverse events of 2 dose regimens of vaginal misoprostol for second trimester termination.

Method.

A prospective, randomised, controlled trial was undertaken in 138 women at 14–20 weeks gestation, in a teaching hospital. Subjects were randomised to receive either regime A: 400 μg of intravaginal misoprostol every 3 h, or regime B: loading dose of 600 μg, followed by 200 μg every 3 h. The main outcome measure was the success rate at 48 h, total dose required, induction-abortion interval, and adverse events. Data was analysed by Student's t-test, Mann–Whitney U-test, the chi-squared test or Fisher's exact test, using Statistica 6.0 software.

Results.

There was no significant difference in the success rates at 24 and 48 h (Regime A: 97.18 and 98.59%; Regime B: 95.45 and 95.45%), and in mean induction-abortion interval (12.97 versus 12.13 h). However, mean misoprostol requirement was significantly higher for Regime A (1701.4 versus 1269.7 μg). The incidence of fever was significantly less in Regime B (32.4 versus 14.9%).

Conclusion.

Use of vaginal misoprostol for second trimester abortion had comparable efficacy with less drug requirement for the 600 μg loading dose followed by 200 μg 3-hourly regime compared to the 400 μg 3-hourly regime.

AbbreviationsPo, parity zero; P1, parity one; S, significant; NS, not significant; HS, highly significant