Mifepristone and Misoprostol for Mid-trimester Terminatio... | NCT02415894

Studies
Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Ukraine

NCT02415894

Sponsor

Gynuity Health Projects

Status

Completed

Last Update Posted

Jul 22, 2016Estimated

Enrollment

172Actual

Phase

Not provided

Conditions

Other Abortion

Interventions

Not provided

Countries

Ukraine

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

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Apr 2, 2015

First Submission Date that Met QC Criteria

Apr 9, 2015

First Posted Date

Apr 14, 2015Estimated

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

Jul 21, 2016

Last Update Posted Date

Jul 22, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 Ukraine.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

172Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of successful abortion		15 hours after start of misoprostol induction

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

Exclusion Criteria:

Known allergy to mifepristone or misoprostol/prostaglandin
Any contraindications to vaginal delivery, including placenta previa
Unable to provide consent

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

Women with mid-trimester pregnancy seeking abortion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tamar Tsereteli, MD, PhD	Gynuity Health Projects	Study Director
Galina Maistruk, MD	Woman Health and Family Planning Charitable Foundation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odessa Regional Hospital		Odesa			Ukraine
Poltava City Maternity Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31164394	Derived	Platais I, Tsereteli T, Maystruk G, Kurbanbekova D, Winikoff B. A prospective study of mifepristone and unlimited dosing of sublingual misoprostol for termination of second-trimester pregnancy in Uzbekistan and Ukraine. BMJ Sex Reprod Health. 2019 Jun 4:bmjsrh-2018-200167. doi: 10.1136/bmjsrh-2018-200167. Online ahead of print.