Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso
1 other identifier
interventional
100
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2017
Typical duration for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2017
CompletedFirst Submitted
Initial submission to the registry
July 14, 2017
CompletedFirst Posted
Study publicly available on registry
August 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedMay 30, 2019
May 1, 2019
2.6 years
July 14, 2017
May 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of successful abortion
Rate of successful abortion, complete evacuation of foetus and placenta with study drugs, within 24 hours of taking misoprostol
24 hours
Study Arms (1)
Medical abortion arm
EXPERIMENTAL200mg of Mifepristone and repeat doses of 400mcg of misoprostol every 3 hours administered for medical abortion in 2nd trimester
Interventions
Medication used in conjunction with misoprostol for abortion
Medication used in conjunction with mifepristone for abortion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Known allergy to mifepristone or misoprostol/prostaglandin
- Any contraindications to vaginal delivery, including placenta previa
- Previous transmural uterine incsion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHUSS
Bobo-Dioulasso, Burkina Faso
CMA Boromo
Boromo, Burkina Faso
CHUYO
Ouagadougou, Burkina Faso
CHR Ouahigouya
Ouahigouya, Burkina Faso
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Blandine Thieba, MD
SOGOB
- STUDY CHAIR
Evelyne Komboigo, MD
SOGOB
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2017
First Posted
August 31, 2017
Study Start
May 20, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
May 30, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share