Cervical preparation using laminaria with adjunctive buccal misoprostol before second-trimester dilation and evacuation procedures: A randomized clinical trial

Objective: This study was undertaken to determine whether buccal misoprostol improves cervical preparation achieved with laminaria before second-trimester dilation and evacuation procedures. Study design: A randomized, double blind, placebo-controlled trial of preoperative cervical preparation with overnight laminaria and either buccal placebo or 400 μg buccal misoprostol approximately 90 minutes before second-trimester surgical abortion. Block randomization was used to provide balanced enrollment into 2 separate gestational age study groups: early (13-15^6/7) and mid (16-20 ^6/7) second trimester. Surgeons tested maximal cervical dilation by inserting the largest dilator that could be passed through the cervical os without force. Subject demographics and preprocedure symptoms were tracked. Results: Groups were similar in regard to age, gravity, parity, delivery type, and gestational age. Data were analyzed from 125 women in the 13 to 15 ^6/7 (30 misoprostol, 32 placebo) and 16 to 20^6/7 (31 misoprostol, 32 placebo) gestational age groups. Overall, misoprostol treatment did not improve the initial mean dilation achieved with laminaria alone in either the 13 to 15^6/7 (46.0 fr ± 5.0; placebo 45.0 fr ± 6.2, P = .68) or 16 to 20^6/7 (50.9 fr ± 5.6, placebo 48.9 fr ± 5.2, P = .16) groups. However, a subanalysis of gestations 19 weeks or more demonstrated significantly greater dilation in the misoprostol group (53.6 fr fr ± 5.3, placebo 48.5 fr ± 5.0, P = .01). Subjects receiving misoprostol reported significantly more cramping than those receiving placebo (13-15^6/7 weeks misoprostol 25/30, 83%; placebo 17/32, 53%, P = .02; 16-20^6/7 week misoprostol 25/31, 81%, placebo 16/32, 50%, P = .02). Conclusion: Cervical dilation with laminaria is augmented by 400 μg buccal misoprostol in gestations 19 weeks or more, but not in earlier gestations. Misoprostol causes more abdominal cramping.