A randomized trial of misoprostol versus laminaria before dilation and evacuation in South Africa

By Daniel Grossman  Deborah Constant  Naomi Lince-Deroche  Jane Harries  Judy Kluge  |  | 

Abstract: 

Objective: To compare complication rates, efficacy and acceptability of buccal misoprostol to laminaria for cervical preparation before dilation and evacuation (D&E) in South Africa. Study design: We performed a randomized, single-blind trial comparing buccal misoprostol 400 mcg (1–2 doses, administered at least 3 h before D&E) to laminaria inserted the day before D&E among women at 13–19 weeks gestation. The primary outcome was expulsion of the fetus prior to surgery; secondary outcomes included other complications, need for mechanical dilation, procedure duration, side effects and satisfaction. Required sample size was 176 to detect a difference in expulsion of 20% to 5%, with a two-sided alpha of 0.05 and 80% power. Results: Due to slow enrollment and low incidence of primary outcome, the study was stopped early. One hundred fifty-nine women were randomized, and 156 received treatment (78 in each group). Mean gestational age was 14.8 weeks (range, 13.0–18.6 weeks). Complications were rare and did not differ by group [three in each group; odds ratio (OR), 1; 95% confidence interval (CI), 0.20–5.11]; this included two expulsions in the misoprostol group (2.6%). Misoprostol participants were more likely to require mechanical dilation compared to those receiving laminaria (35% vs. 8%; OR, 6.4; 95% CI, 2.4–16.5). The proportion of women reporting each side effect was similar except for diarrhea (21.3% in misoprostol group vs. 5.2% in laminaria group, p=0.004). Procedure time and satisfaction did not differ between groups. Conclusions: Both misoprostol and laminaria are associated with a low complication rate in this setting, although misoprostol requires more mechanical dilation and causes more diarrhea. Implications: Cervical preparation using either laminaria or misoprostol can be safely used before D&E up to at least 19 weeks. Physicians using misoprostol must be skilled at mechanical dilation, since this is commonly required.

 

 

Publication details

Journal of Contraception
#90
2014
234
http://www.sciencedirect.com/science/article/pii/S0010782414002467