A comparison of two regimens of misoprostol for second trimester medical termination of pregnancy: a randomized trial

Abstract

The objective of this study was to compare the efficacy and side-effects of two regimens of vaginal misoprostol for second trimester voluntary medical termination of pregnancy (MTP) according to the MTP Act of India. A randomized trial was conducted in 185 women from January 2007 to September 2008. Women in group 1 were given vaginal misoprostol 400 microg every 6 h for a maximum of four doses. Women in group 2 were given vaginal misoprostol 400 microg every 12 h for a maximum of four doses. Our primary outcome measure was induction abortion interval. Secondary outcome measures were success rate, side-effects and completeness of procedure. Results were calculated applying Fisher's exact test, chi-square test, Z test and calculating the P value using an alpha level of 0.05 for Type I error. The mean induction abortion interval in group 1 (12.59 h) was significantly shorter (P < 0.001) than that in the group 2 (16.41 h). The percentage of women who achieved successful abortion within 12 h in group 1 (56.52%) was also significantly higher (P = 0.00005) than that in group 2 (25.80%). The incidence of side-effects was comparable and not clinically serious. It is concluded that the regimen of vaginal misoprostol 400 microg every 6 h was more effective than the regimen of misoprostol every 12 h in medical termination of second trimester pregnancy.

Medical regimens for abortion at 12 weeks and above: a systematic review and meta-analysis

“…One trial with 148 subjects compared the use of misoprostol 400 mcg vaginally every 3 vs. 6 h (Supplements 10C and 11C) [ 44 ]. The 3-h dosing group had a lower rate of ongoing pregnancy at 48 h (RR 0.39, 95% CI 0.17–0.88, low certainty evidence).…”

“…Across all included studies, authors reported 106 SAEs. Ten studies did not supply data on SAEs [ 22 , 26 , 27 , 30 , 31 , 41 , 44 , 49 , 54 , 56 ]. In removing the population of women from the 10 studies not reporting SAEs, we calculated an overall SAE rate of 1.7% (106/6313).…”

“…In our analysis, we only critically appraised dichotomous data on the side effect of bleeding, often measured as hemorrhage (measured or estimated amount over a certain threshold) or excessive bleeding (as reported by the participant or provider). Sixteen studies also reported on continuous outcomes of bleeding, namely, the amount of blood loss or a change in hemoglobin [ 14 , 15 , 21 , 24 , 26 , 29 , 30 , 33 , 36 , 39 , 40 , 44 , [47] , [48] , [49] , 55 ]. Across all of these studies, there was no significant difference in bleeding among study arms from either a statistical or clinical standpoint.…”

A double‐blind randomized controlled trial of mifepristone or placebo before buccal misoprostol for abortion at 14–21 weeks of pregnancy

“…In second-trimester procedures, repeat doses of misoprostol are typically administered without mifepristone until expulsion occurs, leading to successful completion in 26%-96% of women, depending on the dose, dosing interval, route, and allowed time to completion (many only document completion up to 15 hours after initiation of misoprostol) [9][10][11][12][13][14][15]. Regimens that include mifepristone before misoprostol have demonstrated completion rates of 63%-100% and typically result in shorter times to expulsion [6,[16][17][18][19][20][21].…”

Comparison of efficacy of Misoprostol 4 hourly with Misoprostol 6 hour for Medical termination of pregnancy in second trimester.

“…Cervical changes and uterine contractions are caused by misoprostol being a synthetic prostaglandin E1 analogue. 3,4 Prostaglandins have changed the traditional management approach for TOP in 2 nd trimester. Before the availability of misoprostol, other prostaglandins such as prostaglandin E2 and prostaglandin F2 alpha (PGF2a) were mostly used for the termination of second trimester pregnancies.…”