Effectiveness of Two Regimens of Misoprostol Alone for Early Pregnancy Termination and Use of SQPT for At-Home Follow-Up

Summary

This randomized trial will compare the rates of ongoing pregnancy, safety/side effects and acceptability of two medical abortion regimens that are commonly used in Latin America. The first regimen will involve three 800 mcg doses of misoprostol taken buccally in three hour intervals; the second will involve three 800 mcg doses of misoprostol taken sublingually in three hour intervals. This study will also aim to assess the feasibility and acceptability of a semi-quantitative pregnancy test (SQPT) for at-home follow-up in both settings.

Timeline

Start

2014-12

Primary completion

2016-10

Completion

2016-10

Outcome

Met primary endpoint

paper Continuing pregnancy at initial follow-up occurred in 11/201 (5.5%) and 2/189 (1.1%) women, respectively (p=.02). PMID 30831103 ↗

paper Sublingual administration was superior to buccal administration in reducing continuing pregnancy risk after a three-dose regimen of 800 mcg misoprostol. PMID 30831103 ↗

Publications

• Sheldon WR, Durocher J, Dzuba IG, Sayette H, Martin R, Velasco MC, Winikoff B. Early abortion with buccal versus sublingual misoprostol alone: a multicenter, randomized trial. Contraception. 2019 May;99(5):272-277. doi: 10.1016/j.contraception.2019.02.002. Epub 2019 Mar 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Misoprostol	Other / unclassified	800 ug	Other

Indications