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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02981030

Enrollment

102

Registered

2016-12-02

Start date

2016-11-23

Completion date

2017-06-30

Last updated

2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abortion, Therapeutic

Brief 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.

Interventions

DRUGMifepristone

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

DRUGMisoprostol

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
Rate of successful abortion	2 weeks after mifepristone administration

Countries

Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026