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

This study is currently recruiting participants.
Verified December 2016 by Gynuity Health Projects
Sponsor:
ClinicalTrials.gov Identifier:
NCT02981030
First Posted: December 2, 2016
Last Update Posted: December 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Charitable Foundation Women Health & Family Planning
Information provided by (Responsible Party):
Gynuity Health Projects
  Purpose
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 Intervention Phase
Abortion, Therapeutic Drug: Mifepristone Drug: Misoprostol Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Rate of successful abortion [ Time Frame: 2 weeks after mifepristone administration ]

Estimated Enrollment: 100
Study Start Date: November 2016
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981030


Contacts
Contact: Ingrida Platais, MS iplatais@gynuity.org

Locations
Ukraine
Lviv Municipal Women's Consultation No. 2 Recruiting
L'viv, Ukraine
Contact: Maria Tretyakova         
Principal Investigator: Maria Tretyakova, MD         
Vinnitsa Regional Clinical Hospital Recruiting
Vinnitsa, Ukraine
Contact: Inna Kukuruza         
Principal Investigator: Inna Kukuruza, MD         
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
  More Information

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02981030     History of Changes
Other Study ID Numbers: 1037
First Submitted: November 16, 2016
First Posted: December 2, 2016
Last Update Posted: December 12, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents