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

NCT ID: NCT03269279

Last Updated: 2019-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-20

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Medical; Abortion, Fetus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medical abortion arm

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

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

Medication used in conjunction with misoprostol for abortion

Misoprostol

Intervention Type DRUG

Medication used in conjunction with mifepristone for abortion

Interventions

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Mifepristone

Medication used in conjunction with misoprostol for abortion

Intervention Type DRUG

Misoprostol

Medication used in conjunction with mifepristone for abortion

Intervention Type DRUG

Other Intervention Names

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Medabon Misoclear

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Blandine Thieba, MD

Role: STUDY_DIRECTOR

SOGOB

Evelyne Komboigo, MD

Role: STUDY_CHAIR

SOGOB

Locations

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CHUSS

Bobo-Dioulasso, , Burkina Faso

Site Status RECRUITING

CMA Boromo

Boromo, , Burkina Faso

Site Status RECRUITING

CHUYO

Ouagadougou, , Burkina Faso

Site Status RECRUITING

CHR Ouahigouya

Ouahigouya, , Burkina Faso

Site Status RECRUITING

Countries

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Burkina Faso

Central Contacts

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Meighan Tarnagada, MPH

Role: CONTACT

212.448.1230

Ayisha Diop, MS

Role: CONTACT

212.448.1230

Facility Contacts

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Evelyne Komboigo, MD

Role: primary

Evelyne Komboigo, MD

Role: primary

Evelyne Komboigo, MD

Role: primary

Evelyne Komboigo, MD

Role: primary

Other Identifiers

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1036

Identifier Type: -

Identifier Source: org_study_id

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