OBJECTIVE: To compare the efficacy and acceptability of buccal misoprostol or a synthetic osmotic cervical dilator for cervical preparation before same-day late first-trimester and early second-trimester surgical abortion.
METHODS: In this randomized, double-blind trial, we compared 400 micrograms of buccal misoprostol with one synthetic osmotic cervical dilator administered 3–4 hours before surgical abortion among women at 12–15 weeks of gestation. The primary outcome was mean cervical circumferential dilation at the time of surgery. Randomization was stratified by parity and sample size calculated to detect a 3-French difference between groups with 90% power with a two-sided α of .05. Secondary outcomes included ease of further mechanical dilation, procedure time, complications, ripening and procedural pain, and participants' satisfaction.
RESULTS: One hundred twenty-five women were randomized with a mean gestational age of 13 3/7 weeks. Treatment with the synthetic osmotic dilator and buccal misoprostol resulted in similar preoperative dilation (mean French 33.9 compared with 32.1, P=.065). Procedure time, procedural pain, number of complications, and participants' satisfaction and preferences did not differ between treatment groups. Misoprostol participants experienced more pain during ripening (P=.008). All but six participants, three in each arm, required mechanical dilation at the time of the procedure. This manual dilation was subjectively easier in participants who received the synthetic osmotic cervical dilator (P=.015). All participants were able to have their procedure in 1 day without further cervical preparation.
CONCLUSION: Either buccal misoprostol or a synthetic osmotic cervical dilator provides adequate dilation for same-day late first-trimester and early second-trimester abortion. Despite more pain with misoprostol, patient satisfaction with misoprostol and the synthetic dilator is similar.
CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov, NCT00835731.
LEVEL OF EVIDENCE: I