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

NCT ID: NCT02415894

Last Updated: 2016-07-22

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

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-04-30

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 Ukraine.

Detailed Description

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Conditions

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Other Abortion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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

Exclusion Criteria

* Known allergy to mifepristone or misoprostol/prostaglandin
* Any contraindications to vaginal delivery, including placenta previa
* Unable to provide consent
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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Tamar Tsereteli, MD, PhD

Role: STUDY_DIRECTOR

Gynuity Health Projects

Galina Maistruk, MD

Role: STUDY_DIRECTOR

Woman Health and Family Planning Charitable Foundation

Locations

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Odessa Regional Hospital

Odesa, , Ukraine

Site Status

Poltava City Maternity Hospital

Poltava, , Ukraine

Site Status

Vinnitsa Regional Hospital

Vinnitsa, , Ukraine

Site Status

Countries

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Ukraine

References

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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.

Reference Type DERIVED
PMID: 31164394 (View on PubMed)

Other Identifiers

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1025

Identifier Type: -

Identifier Source: org_study_id

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