Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion

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

NA

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-07-31

Brief Summary

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This study will test ways to give women more options and flexibility when they are ending their unwanted pregnancies. The investigators will look at uptake and acceptability of using mifepristone outside of the clinic for pregnancy termination.

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Detailed Description

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This study will investigate the uptake of mifepristone administration outside of the health center for pregnancy termination and its acceptability to women and to their providers. In addition, we plan to evaluate rates of follow-up, adherence, efficacy, complications, days of missed work and/or school, and lost income. This will be a prospective, comparative, non-randomized, open-label study. All women who are seeking medical abortion will be offered participation in the study. Women who enroll in the study will be given a choice between taking the mifepristone outside the center or in the center setting.

Conditions

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Termination of Pregnancy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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In-Center Use of Mifepristone

Participants who choose to take mifepristone in the center

Group Type NO_INTERVENTION

No interventions assigned to this group

Out-of-Center Use of Mifepristone

Participants who choose to take the mifepristone outside of the center

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

Mifepristone use outside of the center

Interventions

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Mifepristone

Mifepristone use outside of the center

Intervention Type DRUG

Other Intervention Names

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mifeprex

Eligibility Criteria

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Inclusion Criteria

* Women 18 years and older
* seeking medical abortion services
* in general good health
* assessed by a clinician to have an intrauterine pregnancy less than 64 days L.M.P on the day mifepristone will be taken
* eligible for medical abortion according to clinician and center standards.