NCT02415894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 22, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

April 2, 2015

Last Update Submit

July 21, 2016

Conditions

Other Abortion

Outcome Measures

Primary Outcomes (1)

  • Rate of successful abortion

    15 hours after start of misoprostol induction

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with mid-trimester pregnancy seeking abortion

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Odessa Regional Hospital

Odesa, Ukraine

Location

Poltava City Maternity Hospital

Poltava, Ukraine

Location

Vinnitsa Regional Hospital

Vinnitsa, Ukraine

Location

Related Publications (1)

  • 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.

    PMID: 31164394DERIVED

Study Officials

  • Tamar Tsereteli, MD, PhD

    Gynuity Health Projects

    STUDY DIRECTOR

  • Galina Maistruk, MD

    Woman Health and Family Planning Charitable Foundation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2015

First Posted

April 14, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

July 22, 2016

Record last verified: 2016-07

Locations

UA(3)