A randomized controlled trial of 400-μg sublingual misoprostol versus manual vacuum aspiration for the treatment of incomplete abortion in two Egyptian hospitals

Abstract

Objective: To compare the safety, efficacy, and acceptability of 400-μg sublingual misoprostol with that of manual vacuum aspiration (MVA) in 2 Egyptian hospitals.

Methods: Participating women were randomized to either MVA or misoprostol treatment for incomplete abortion. The primary outcome, complete uterine evacuation, was determined 1 week later, as were adverse effects, change in hemoglobin, acceptability, and satisfaction.

Results: Complete uterine evacuation was achieved in 98.3% of women who received misoprostol and 99.7% who underwent MVA (relative risk [RR] 0.99; 95% confidence interval [CI], 0.97-1.00). A decrease in hemoglobin of 2g/dL or more was comparably rare in the 2 groups (0.3% misoprostol vs 0.9% MVA; RR 0.34 [95% CI, 0.04-3.21]). Mean change in hemoglobin was also clinically similar (-0.5 g/dL misoprostol vs -0.4 g/dL MVA; P<0.01). Heavy bleeding was rare (2.4% misoprostol vs 1.6% MVA; RR 1.55 [95% CI, 0.51-4.68]) following treatment. Nearly all women (96.8% misoprostol vs 98.3% MVA) were satisfied with their treatment but those who received misoprostol were significantly more likely to prefer that method in the future (81.9% vs 62.8%; RR 1.30 [95% CI, 1.19-1.43]).

Conclusion: The high efficacy, safety, and acceptability of 400-μg sublingual misoprostol indicate that it is analogous to surgery as a first-line treatment for incomplete abortion. Misoprostol might improve post-abortion care when resources are limited and surgical treatment is unavailable.

Trial registration: ClinicalTrials.gov NCT00466999.