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

Not Applicable

Completed

• Conditions: Termination of Pregnancy
• Interventions: Drug: Mifepristone

• Registration Number: NCT01811056
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-14
• Study Start: 2013-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 401

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.

Exclusion Criteria

• will be followed up by beta HCG and not ultrasound

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Out-of-Center Use of Mifepristone	Mifepristone	Participants who choose to take the mifepristone outside of the center

Primary Outcome Measures

Name	Time	Method
Proportion of participants who would recommend outside-of-center administration to a friend	1-2 weeks
Proportion of participants who would choose outside of center administration of mifepristone again	1-2 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of women who select outside-of-clinic use of mifepristone	1-2 weeks
Adherence	1-2 weeks	Did not take complete therapy Mifepristone not taken at scheduled time Mifepristone not taken within 63 days L.M.P. Misoprostol not taken within 48 hours of mifepristone administration Did not return for confirmation of outcome
Success Rates/Method Failure	1-2 weeks	Ongoing pregnancy at study end Incomplete abortion at study end Medically indicated surgical intervention during study
Provider-related outcomes	1-2 weeks	Unscheduled visits to center Unscheduled calls to center/clinician on-call Provider satisfaction- better than center mifepristone, equivalent, or worse; impact on workload; impact on quality of care

Trial Locations

Locations (3)

Planned Parenthood of the Great Northwest; 🇺🇸 Seattle, Washington, United States

Planned Parenthood of New York City; 🇺🇸 New York, New York, United States

Planned Parenthood of Northern New England; 🇺🇸 Barre, Burlington, Rutland, Vermont, United States