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

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

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.

Study Overview

• Status: Completed
• Conditions: Abortion, Therapeutic
• Intervention / Treatment: Drug: Mifepristone; Drug: Misoprostol

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of successful abortion	2 weeks after mifepristone administration

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: 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; Study Director: Galyna Maystruk, MD, Charitable Foundation Women Health & Family Planning

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2016
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 2, 2016

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 14, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Misoprostol; Mifepristone
• Other Study ID Numbers: 1037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO