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OpenTrials
Completed

NCT Number: NCT01811056

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

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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Key information

Conditions

Termination of Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood of New York City, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mifepristone

Drug

Mifepristone use outside of the center

Other names: mifeprex

Primary outcomes

  1. Proportion of participants who would choose outside of center administration of mifepristone again

    Time frame: 1-2 weeks

  2. Proportion of participants who would recommend outside-of-center administration to a friend

    Time frame: 1-2 weeks

Secondary outcomes

  1. Proportion of women who select outside-of-clinic use of mifepristone

    Time frame: 1-2 weeks

  2. Success Rates/Method Failure

    Time frame: 1-2 weeks

    Ongoing pregnancy at study end Incomplete abortion at study end Medically indicated surgical intervention during study

  3. Adherence

    Time frame: 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

  4. Provider-related outcomes

    Time frame: 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

Other outcomes

  1. Productivity

    Time frame: 1-2 weeks

    Missed days of school and/or work Additional costs for childcare or eldercare

  2. Reasons for selection of mifepristone administration site and experiences with home administration Reason

    Time frame: 1-2 weeks

    Reasons for selection of mifepristone administration site and experiences with home administration

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 14, 2013
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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