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

Sponsor
Gynuity Health Projects (Other)
Overall Status
Unknown status
CT.gov ID
NCT03269279
Collaborator
(none)
100
Enrollment
4
Locations
1
Arm
31.4
Anticipated Duration (Months)
25
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy (13-22 Weeks LMP) in Burkina Faso
Actual Study Start Date :
May 20, 2017
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Medical abortion arm

200mg of Mifepristone and repeat doses of 400mcg of misoprostol every 3 hours administered for medical abortion in 2nd trimester

Drug: Mifepristone
Medication used in conjunction with misoprostol for abortion
Other Names:
  • Medabon

    • Drug: Misoprostol
    Medication used in conjunction with mifepristone for abortion
    Other Names:
  • Misoclear

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHUSS Bobo-Dioulasso Burkina Faso
    2 CMA Boromo Boromo Burkina Faso
    3 CHUYO Ouagadougou Burkina Faso
    4 CHR Ouahigouya Ouahigouya Burkina Faso

    Sponsors and Collaborators

    • Gynuity Health Projects

    Investigators

    • Study Director: Blandine Thieba, MD, SOGOB
    • Study Chair: Evelyne Komboigo, MD, SOGOB

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gynuity Health Projects
    ClinicalTrials.gov Identifier:
    NCT03269279
    Other Study ID Numbers:
    • 1036
    First Posted:
    Aug 31, 2017
    Last Update Posted:
    May 30, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Misoprostol
    Mifepristone

    Study Results

    No Results Posted as of May 30, 2019