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

Abortion, Therapeutic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981030
• Other study ID #: 1037
• Status: Completed
• Phase: Phase 4
• Start date: November 23, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: June 2018
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Abortion, Therapeutic

Intervention

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

Locations

Country	Name	City	State
Ukraine	Lviv Municipal Women's Consultation No. 2	L'viv
Ukraine	Vinnitsa Regional Clinical Hospital	Vinnitsa

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	Charitable Foundation Women Health & Family Planning

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful abortion		2 weeks after mifepristone administration