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CompletedNCT02981030Updated Jun 18, 2018

Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine

A Phase 4 interventional study of Mifepristone and Misoprostol in Abortion, Therapeutic, sponsored by Gynuity Health Projects. Completed at 2 sites in Ukraine. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-18.

Sponsored by Gynuity Health Projects · Phase 4, Interventional, and Health services research

Phase
Phase 4
Study type
Interventional
Enrollment
102
Allocation
Not applicable
Sex
Female
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Study summary

The study will examine how a simplified outpatient medical abortion procedure using mifepristone and misoprostol, with the option to take mifepristone at a place of woman's choosing, works in Ukraine. The investigators intend to demonstrate the efficacy of oral administration of 200 mg mifepristone and buccal administration of 800 mcg misoprostol with gestations through 70 days, as well as the acceptability of this method.

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Conditions studied

  • Abortion, Therapeutic
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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.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Have an intrauterine pregnancy consistent with gestational age less than 71 days;
  • Be able to understand and willing to sign a consent form;
  • Be eligible for medical abortion according to the clinician's assessment;
  • Be able to return to the clinic and able to contact study staff or emergency medical services, if needed;
  • Be willing to provide an address and/or telephone number for purposes of follow-up;
  • Agree to comply with the study procedures and visit schedule.

Exclusion criteria

Exclusion Criteria:

  • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
  • Chronic renal failure;
  • Concurrent long-term corticosteroid therapy;
  • History of allergy to mifepristone, or misoprostol or another prostaglandin;
  • History of hemorrhagic disorders or concurrent anticoagulant therapy;
  • History of inherited porphyrias;
  • Intrauterine device in place (must be removed before mifepristone is administered).
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Study design

Phase
Phase 4
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    Simplified medical abortion

    Women seeking medical abortion will be offered the option self-administering the medications, mifepristone and misoprostol at home.

    Drug: Mifepristone · Drug: Misoprostol

Interventions

  • DrugMifepristone

    Women seeking medical abortion will be offered the option to take mifepristone at home

  • DrugMisoprostol

    Women seeking medical abortion will be offered the option to take misoprostol at home. Misoprostol will be administered buccally.

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What researchers measure

Primary outcomes

  1. Rate of successful abortion

    Time frame: 2 weeks after mifepristone administration

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Study locations

2 sites
  • Lviv Municipal Women's Consultation No. 2
    L'viv, Ukraine
  • Vinnitsa Regional Clinical Hospital
    Vinnitsa, Ukraine
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02981030
Lead sponsor
Gynuity Health Projects
Collaborators
Charitable Foundation Women Health & Family Planning
Responsible party
Sponsor
First posted
Dec 2, 2016
Start date
Nov 23, 2016
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017
Last update
Jun 18, 2018

Study contacts

Ingrida Platais, MS
principal investigator · Gynuity Health Projects
Tamar Tsereteli, MD, MSc, PhD
principal investigator · Gynuity Health Projects
Beverly Winikoff, MD, MPH
principal investigator · Gynuity Health Projects
Galyna Maystruk, MD
study director · Charitable Foundation Women Health & Family Planning

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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