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Completed

NCT Number: NCT02981030

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

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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Key information

Conditions

Abortion, Therapeutic

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Lviv Municipal Women's Consultation No. 2, Lviv, Ukraine

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mifepristone

Drug

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

Misoprostol

Drug

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

Primary outcomes

  1. Rate of successful abortion

    Time frame: 2 weeks after mifepristone administration

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Charitable Foundation Women Health & Family Planning

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 2, 2016
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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