Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso

Phase 3

• Conditions: Medical; Abortion, Fetus
• Interventions: Drug: Mifepristone; Drug: Misoprostol

• Registration Number: NCT03269279
• Lead Sponsor: Gynuity Health Projects

Brief Summary

The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Burkina Faso.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-20
• Study First Submitted: 2017-07-14
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-08-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-28
• Last Update Posted: 2019-05-30
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Having an ongoing pregnancy of 13-22 weeks gestation
• Be willing to undergo surgical completion if necessary
• Have no contraindications to study procedures, according to provider
• Be willing and able to consent to participate in the study
• Be willing to follow study procedures
• Respect legal indications for obtaining an abortion

Exclusion Criteria

• Known allergy to mifepristone or misoprostol/prostaglandin
• Any contraindications to vaginal delivery, including placenta previa
• Previous transmural uterine incsion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medical abortion arm	Mifepristone	200mg of Mifepristone and repeat doses of 400mcg of misoprostol every 3 hours administered for medical abortion in 2nd trimester
Medical abortion arm	Misoprostol	200mg of Mifepristone and repeat doses of 400mcg of misoprostol every 3 hours administered for medical abortion in 2nd trimester

Primary Outcome Measures

Name	Time	Method
Rate of successful abortion	24 hours	Rate of successful abortion, complete evacuation of foetus and placenta with study drugs, within 24 hours of taking misoprostol

Trial Locations

Locations (4)

CHUYO; 🇧🇫 Ouagadougou, Burkina Faso

CMA Boromo; 🇧🇫 Boromo, Burkina Faso

CHR Ouahigouya; 🇧🇫 Ouahigouya, Burkina Faso

CHUSS; 🇧🇫 Bobo-Dioulasso, Burkina Faso