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History of Changes for Study: NCT03269279
Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso
Latest version (submitted May 28, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 30, 2017 None (earliest Version on record)
2 August 6, 2018 Study Status and Arms and Interventions
3 May 28, 2019 Recruitment Status and Study Status
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Study NCT03269279
Submitted Date:  August 30, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1036
Brief Title: Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso
Official Title: Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy (13-22 Weeks LMP) in Burkina Faso
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2017
Overall Status: Recruiting
Study Start: May 20, 2017
Primary Completion: May 19, 2018 [Anticipated]
Study Completion: May 19, 2018 [Anticipated]
First Submitted: July 14, 2017
First Submitted that
Met QC Criteria:
August 30, 2017
First Posted: August 31, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
August 30, 2017
Last Update Posted: August 31, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Gynuity Health Projects
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Medical; Abortion, Fetus
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Drug: Misoprostol
Medication used in conjunction with mifepristone for abortion
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age:
Maximum Age:
Sex: Female
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Meighan Tarnagada, MPH
Telephone: 212.448.1230
Email: mtarnagada@gynuity.org
Central Contact Backup: Ayisha Diop, MS
Telephone: 212.448.1230
Email: adiop@gynuity.org
Study Officials: Blandine Thieba, MD
Study Director
SOGOB
Evelyne Komboigo, MD
Study Chair
SOGOB
Locations: Burkina Faso
CHUSS
[Recruiting]
Bobo-Dioulasso, Burkina Faso
Contact:Contact: Evelyne Komboigo, MD
CMA Boromo
[Recruiting]
Boromo, Burkina Faso
Contact:Contact: Evelyne Komboigo, MD
CHUYO
[Recruiting]
Ouagadougou, Burkina Faso
Contact:Contact: Evelyne Komboigo, MD
CHR Ouahigouya
[Recruiting]
Ouahigouya, Burkina Faso
Contact:Contact: Evelyne Komboigo, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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