CompletedNCT02415894Updated Jul 22, 2016

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

An observational study in Other Abortion, sponsored by Gynuity Health Projects. Completed at 3 sites in Ukraine. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-22.

Sponsored by Gynuity Health Projects · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 172
Sex: Female

Study 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.

Conditions studied

Other Abortion

In context

Lead sponsor

Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: Female
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

Women with mid-trimester pregnancy seeking abortion

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

Exclusion Criteria:

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 172 participants (actual)
Patient registry: No

What researchers measure

Primary outcomes

Rate of successful abortion
Time frame: 15 hours after start of misoprostol induction

Study locations

3 sites

Odessa Regional Hospital
Odessa, Ukraine
Poltava City Maternity Hospital
Poltava, Ukraine
Vinnitsa Regional Hospital
Vinnitsa, Ukraine

References and documents

Publications

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. PubMed 31164394 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02415894
Lead sponsor: Gynuity Health Projects
Responsible party: Sponsor
First posted: Apr 14, 2015
Start date: Apr 2015
Primary completion: Apr 2016
Completion: Apr 2016
Last update: Jul 22, 2016

Study contacts

Tamar Tsereteli, MD, PhD

study director · Gynuity Health Projects

Galina Maistruk, MD

study director · Woman Health and Family Planning Charitable Foundation

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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