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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-23

Study Completion Date

2017-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Abortion, Therapeutic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Simplified medical abortion

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

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

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

Misoprostol

Intervention Type DRUG

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

Interventions

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Mifepristone

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

Intervention Type DRUG

Misoprostol

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

Intervention Type DRUG

Eligibility Criteria

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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).

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes