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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03269279
Recruitment Status : Unknown
Verified May 2019 by Gynuity Health Projects.
Recruitment status was:  Recruiting
First Posted : August 31, 2017
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Study Description
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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
Medical; Abortion, Fetus Drug: Mifepristone Drug: Misoprostol Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abortion Pregnancy

Arms and Interventions
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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 Name: Medabon

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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of successful abortion [ Time Frame: 24 hours ]
    Rate of successful abortion, complete evacuation of foetus and placenta with study drugs, within 24 hours of taking misoprostol


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269279


Contacts
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Contact: Meighan Tarnagada, MPH 212.448.1230 mtarnagada@gynuity.org
Contact: Ayisha Diop, MS 212.448.1230 adiop@gynuity.org

Locations
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Burkina Faso
CHUSS Recruiting
Bobo-Dioulasso, Burkina Faso
Contact: Evelyne Komboigo, MD         
CMA Boromo Recruiting
Boromo, Burkina Faso
Contact: Evelyne Komboigo, MD         
CHUYO Recruiting
Ouagadougou, Burkina Faso
Contact: Evelyne Komboigo, MD         
CHR Ouahigouya Recruiting
Ouahigouya, Burkina Faso
Contact: Evelyne Komboigo, MD         
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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Study Director: Blandine Thieba, MD SOGOB
Study Chair: Evelyne Komboigo, MD SOGOB
More Information
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT03269279    
Other Study ID Numbers: 1036
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
 Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Contraceptive Agents, Hormonal
Menstruation-Inducing Agents