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

Sponsor
Gynuity Health Projects (Other)
Overall Status
Completed
CT.gov ID
NCT02981030
Collaborator
Charitable Foundation Women Health & Family Planning (Other)
102
Enrollment
2
Locations
1
Arm
7.2
Actual Duration (Months)
51
Patients Per Site
7.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
102 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine: A Demonstration Study of 800 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 70 Days Gestation
Actual Study Start Date :
Nov 23, 2016
Actual Primary Completion Date :
Jun 30, 2017
Actual Study Completion Date :
Jun 30, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Simplified medical abortion

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Rate of successful abortion [2 weeks after mifepristone administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
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:

  • 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lviv Municipal Women's Consultation No. 2 L'viv Ukraine
2 Vinnitsa Regional Clinical Hospital Vinnitsa Ukraine

Sponsors and Collaborators

  • Gynuity Health Projects
  • Charitable Foundation Women Health & Family Planning

Investigators

  • Principal Investigator: Ingrida Platais, MS, Gynuity Health Projects
  • Principal Investigator: Tamar Tsereteli, MD, MSc, PhD, Gynuity Health Projects
  • Principal Investigator: Beverly Winikoff, MD, MPH, Gynuity Health Projects
  • Study Director: Galyna Maystruk, MD, Charitable Foundation Women Health & Family Planning

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT02981030
Other Study ID Numbers:
  • 1037
First Posted:
Dec 2, 2016
Last Update Posted:
Jun 18, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Misoprostol
Mifepristone

Study Results

No Results Posted as of Jun 18, 2018