NCT02704481

Non-surgical Alternatives to Treatment of Failed Medical Abortion

Non-surgical Alternatives to Treatment of Failed Medical Abortion: A Randomized Controlled Double-blind Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary outcome of this study is to compare the effectiveness of a second complete course of 200 mg mifepristone and 800 mcg misoprostol for ongoing pregnancy following mifepristone-misoprostol medical abortion.

Detailed description

This is a multi-site double-blind, randomized controlled trial to assess treatment with a repeat mifepristone-misoprostol regimen and with a two-dose misoprostol-alone regimen in women who are diagnosed with ongoing pregnancy ≤77 days gestational age at 1-week follow-up after medical abortion. The sample will be stratified in two cohorts: women with ongoing pregnancies \<= 56 days of gestation and women with ongoing pregnancies 57-77 days of gestation. Eligible women who agree to participate in the study will be randomly assigned to either Group 1 for treatment with 200 mg mifepristone followed in 24-48 hours by 800 mcg buccal misoprostol, followed by 4 misoprostol placebo pills 3-12 hours later, or to Group 2 for treatment with one mifepristone placebo pill, followed by 800 mcg buccal misoprostol 24-48 hours later and another 800 mcg dose repeated in 3-12 hours. The study will also assess the acceptability of additional medication for ongoing pregnancy following an initial course of mifepristone-misoprostol medical abortion.

Conditions

• Abortion Failure

Interventions

Type	Name	Description
DRUG	Mifepristone	200mg oral mifepristone
DRUG	Misoprostol	800mcg buccal misoprostol
DRUG	Placebo mifepristone	Matching placebo pill of 200mg mifepristone
DRUG	Placebo misoprostol	Matching placebo pills of 800mcg misoprostol

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-01-16
• Completion: 2019-01-16
• First posted: 2016-03-10
• Last updated: 2021-07-26

Locations

14 sites across 1 country: United States