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

Gynuity Health Projects

Status and phase: Unknown; Phase 3

Conditions: Medical; Abortion, Fetus

Treatments: Drug: Mifepristone; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03269279

1036

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Medical abortion arm

Experimental group

Description:

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

Treatment:

Drug: Misoprostol

Drug: Mifepristone