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

NCT02981030 | Completed Phase 4

• 1 other identifier: 1037
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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.

Conditions

Abortion, Therapeutic

Outcome Measures

Primary Outcomes (1)

• Rate of successful abortion

  2 weeks after mifepristone administration

Study Arms (1)

Simplified medical abortion

EXPERIMENTAL

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

Drug: Mifepristone; Drug: Misoprostol

Interventions

Mifepristone DRUG

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

Simplified medical abortion

Misoprostol DRUG

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

Simplified medical abortion

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Charitable Foundation Women Health & Family Planning: collaborator

Study Sites (2)

Lviv Municipal Women's Consultation No. 2

Lviv, Ukraine

Location

Vinnitsa Regional Clinical Hospital

Vinnitsa, Ukraine

Location

MeSH Terms

Interventions

Mifepristone; Misoprostol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Galyna Maystruk, MD

  Charitable Foundation Women Health & Family Planning

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: December 2, 2016
• Study Start: November 23, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: June 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

UA (2)