A randomized comparison of misoprostol to intrauterine instillation of hypertonic saline plus a prostaglandin F2alpha analogue for second-trimester induction termination in Uzbekistan

Abstract

Background: The study was conducted to compare the efficacy and acceptability of second-trimester induction termination using vaginal misoprostol to hypertonic saline and d-cloprostenol, a prostaglandin F(2alpha) (PGF) analogue, in Tashkent, Uzbekistan.

Study design: Eleven clinics providing second-trimester induction terminations were randomized to provide one of two regimens for second-trimester induction termination: vaginal misoprostol 400 mcg every 3 h or hypertonic 10% saline intrauterine instillation plus an intravenous PGF analogue, d-cloprostenol, 2.5 mg/h. Demographic information, and obstetric and medical history data were collected, and interviewers administered questionnaires to measure procedural pain and satisfaction. Differences in procedure time and complication rate, the primary outcomes, were analyzed with survival analysis and chi(2) tests.

Results: Of 228 participants, 120 received misoprostol and 108 received hypertonic saline and d-cloprostenol; the groups did not significantly differ by age, parity or gestational age. Both misoprostol and saline procedures were effective, with 99.2% and 100% successful abortion rates, respectively. Median procedure time (13.1 vs. 29.2 h, p<.001), and number of women with retained placenta (2 vs. 70, p<.001) or hemorrhage (3 vs. 19, p=.001) were lower for the misoprostol group. Both provider (p<.001) and patient (p<.001) procedural satisfaction scores were higher for the misoprostol group.

Conclusion: While equally effective, vaginal misoprostol had a shorter time to abortion, was more acceptable to providers and patients and had fewer complications than saline instillation plus intravenous administration of a PGF analogue in Tashkent. This evidence supports change of the existing standard of care for second-trimester induction termination in Uzbekistan.