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Trial record 2 of 6 for:    mifepristone , planned parenthood | Gynuity

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 11, 2013
First Posted Date  ICMJE March 14, 2013
Last Update Posted Date August 13, 2015
Study Start Date  ICMJE April 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
  • Proportion of participants who would choose outside of center administration of mifepristone again [ Time Frame: 1-2 weeks ]
  • Proportion of participants who would recommend outside-of-center administration to a friend [ Time Frame: 1-2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
  • Proportion of women who select outside-of-clinic use of mifepristone [ Time Frame: 1-2 weeks ]
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 13, 2013)
  • Productivity [ Time Frame: 1-2 weeks ]
    Missed days of school and/or work Additional costs for childcare or eldercare
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion
Official Title  ICMJE Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Termination of Pregnancy
Intervention  ICMJE Drug: Mifepristone
Mifepristone use outside of the center
Other Name: mifeprex
Study Arms  ICMJE
  • 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
    Intervention: Drug: Mifepristone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2014)
401
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2013)
400
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01811056
Other Study ID Numbers  ICMJE 1006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynuity Health Projects
Study Sponsor  ICMJE Gynuity Health Projects
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
PRS Account Gynuity Health Projects
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP