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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03269279
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Tracking Information
First Submitted Date  ICMJE July 14, 2017
First Posted Date  ICMJE August 31, 2017
Last Update Posted Date May 30, 2019
Actual Study Start Date  ICMJE May 20, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03269279 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso
Official Title  ICMJE Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy (13-22 Weeks LMP) in Burkina Faso
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Medical; Abortion, Fetus
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Medical abortion arm
200mg of Mifepristone and repeat doses of 400mcg of misoprostol every 3 hours administered for medical abortion in 2nd trimester
Interventions:
  • Drug: Mifepristone
  • Drug: Misoprostol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Meighan Tarnagada, MPH 212.448.1230 mtarnagada@gynuity.org
Contact: Ayisha Diop, MS 212.448.1230 adiop@gynuity.org
Listed Location Countries  ICMJE Burkina Faso
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03269279
Other Study ID Numbers  ICMJE 1036
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gynuity Health Projects
Study Sponsor  ICMJE Gynuity Health Projects
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Blandine Thieba, MD SOGOB
Study Chair: Evelyne Komboigo, MD SOGOB
PRS Account Gynuity Health Projects
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP