Mifepristone and Misoprostol for 2nd Trimester Terminatio... | NCT03269279

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

NCT03269279

Sponsor

Gynuity Health Projects

Status

Unknown status

Last Update Posted

May 30, 2019Actual

Enrollment

100Estimated

Phase

Phase 3

Conditions

Medical; Abortion, Fetus

Interventions

Mifepristone
Misoprostol

Countries

Burkina Faso

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2017Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Jul 14, 2017

First Submission Date that Met QC Criteria

Aug 30, 2017

First Posted Date

Aug 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2019

Last Update Posted Date

May 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Medical abortion arm	Experimental	200mg of Mifepristone and repeat doses of 400mcg of misoprostol every 3 hours administered for medical abortion in 2nd trimester	Drug: Mifepristone Drug: Misoprostol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mifepristone	Drug	Medication used in conjunction with misoprostol for abortion	Medical abortion arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Meighan Tarnagada, MPH	Contact	212.448.1230		mtarnagada@gynuity.org
Ayisha Diop, MS	Contact	212.448.1230		adiop@gynuity.org

Overall Officials

Name	Affiliation	Role
Blandine Thieba, MD	SOGOB	Study Director
Evelyne Komboigo, MD	SOGOB	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHUSS	Recruiting	Bobo-Dioulasso			Burkina Faso

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015735	Mifepristone
D016595	Misoprostol

Ancestor Terms

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided