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

Medical; Abortion, Fetus Clinical Trial

Official title:

Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy (13-22 Weeks LMP) in Burkina Faso

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03269279
• Other study ID #: 1036
• Status: Recruiting
• Phase: Phase 3
• Start date: May 20, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2019
• Source: Gynuity Health Projects
• Contact: Meighan Tarnagada, MPH
• Phone: 212.448.1230
• Email: mtarnagada[@]gynuity.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Medical; Abortion, Fetus

Intervention

Drug:
• Mifepristone
Medication used in conjunction with misoprostol for abortion
• Misoprostol
Medication used in conjunction with mifepristone for abortion

Locations

Country	Name	City	State
Burkina Faso	CHUSS	Bobo-Dioulasso
Burkina Faso	CMA Boromo	Boromo
Burkina Faso	CHUYO	Ouagadougou
Burkina Faso	CHR Ouahigouya	Ouahigouya

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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