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

Int J Gynaecol Obstet. 2010 Nov;111(2):131-5. doi: 10.1016/j.ijgo.2010.06.021.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abortifacient Agents, Nonsteroidal / administration & dosage*
  • Abortifacient Agents, Nonsteroidal / adverse effects
  • Abortion, Incomplete / diagnostic imaging
  • Abortion, Incomplete / drug therapy
  • Abortion, Incomplete / therapy*
  • Administration, Sublingual
  • Adult
  • Egypt
  • Female
  • Humans
  • Misoprostol / administration & dosage*
  • Misoprostol / adverse effects
  • Patient Satisfaction
  • Treatment Outcome
  • Ultrasonography
  • Vacuum Curettage*
  • Young Adult

Substances

  • Abortifacient Agents, Nonsteroidal
  • Misoprostol

Associated data

  • ClinicalTrials.gov/NCT00466999