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De-Medicalizing Mifepristone Medical Abortion

NCT00120224 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4410

Last updated 2007-04-27

No results posted yet for this study

Summary

This study will investigate the possibility that medical abortion using mifepristone and misoprostol - a safe, proven therapy for terminating early first trimester pregnancy - can be administered in a manner that is simpler and less costly than that routinely employed in the United States.

The researchers hypothesize that:

1. Practitioners themselves, based on history and examination but without sonography, are able to dependably and correctly determine which patients are eligible for medical abortion and which patients either are not eligible or require further evaluation to determine eligibility.
2. Practitioners themselves, based on a symptom diary and low-sensitivity pregnancy test but without sonography, are able to dependably and correctly determine when a successful medical abortion has taken place and when referral for other possible outcomes should be made.
3. A symptom diary and low-sensitivity pregnancy test are safe and effective means of separating those women who could benefit from a follow-up visit from those who do not need one.

Conditions

  • Medical Abortion

Sponsors & Collaborators

  • Planned Parenthood Federation of America

    collaborator OTHER

  • David and Lucile Packard Foundation

    collaborator OTHER

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Wesley Clark, MPH · Gynuity Health Projects

  • Beverly Winikoff, MD, MPH · Gynuity Health Projects

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Completion
2007-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00120224 on ClinicalTrials.gov