NCT02299401

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

Assessing the Effectiveness of Two Regimens of Misoprostol Alone for Early Pregnancy Termination and Use of a Semi-Quantitative Pregnancy Test for At-Home Follow-Up

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 401 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DRUG	Misoprostol	Women will receive three 800 mcg doses of misoprostol.
DEVICE	Semi-quantitative pregnancy test	All women will be given a semi-quantitative pregnancy test (SQPT) for at-home follow-up.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-11-24
• Last updated: 2016-11-03

Locations

2 sites across 2 countries: Bolivia, Ecuador