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

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ClinicalTrials.gov Identifier: NCT01811056
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Termination of Pregnancy Drug: Mifepristone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion
Study Start Date : April 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: In-Center Use of Mifepristone
Participants who choose to take mifepristone in the center
Experimental: Out-of-Center Use of Mifepristone
Participants who choose to take the mifepristone outside of the center
Drug: Mifepristone
Mifepristone use outside of the center
Other Name: mifeprex




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811056


Locations
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United States, New York
Planned Parenthood of New York City
New York, New York, United States
United States, Vermont
Planned Parenthood of Northern New England
Barre, Burlington, Rutland, Vermont, United States
United States, Washington
Planned Parenthood of the Great Northwest
Seattle, Washington, United States
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01811056     History of Changes
Other Study ID Numbers: 1006
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015
Keywords provided by Gynuity Health Projects:
medical abortion
mifepristone
Additional relevant MeSH terms:
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Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents