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Uptake and Acceptability of Home-use of Mifepristone for 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: NCT00994734
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : April 17, 2012
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Tracking Information
First Submitted Date  ICMJE October 9, 2009
First Posted Date  ICMJE October 14, 2009
Last Update Posted Date April 17, 2012
Study Start Date  ICMJE May 2009
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2012)
  • Proportion of women who select home-use of mifepristone [ Time Frame: 1-2 weeks ]
  • Satisfaction with Method [ Time Frame: 1-2 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2009)
  • Proportion of women who select home-use of mifepristone
  • Satisfaction with Method
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion
Official Title  ICMJE Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion
Brief Summary The primary aim of this study is to assess the acceptability of home-use mifepristone for termination of pregnancy among women who choose it and their providers. The investigators' secondary aims are to assess rates of follow-up, adherence, efficacy, complications, lost productivity, and to estimate the minimum proportion of women who choose home-use over clinic use of mifepristone.
Detailed Description Not Provided
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
home administration of mifepristone
Study Arms  ICMJE
  • No Intervention: clinic administration of mifepristone
  • Experimental: home administration of mifepristone
    Intervention: Drug: Mifepristone
Publications * Conkling K, Karki C, Tuladhar H, Bracken H, Winikoff B. A prospective open-label study of home use of mifepristone for medical abortion in Nepal. Int J Gynaecol Obstet. 2015 Mar;128(3):220-3. doi: 10.1016/j.ijgo.2014.09.022. Epub 2014 Nov 27.

*   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: October 13, 2009)
615
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Reproductive age women seeking abortion services.
  • Eligible women will be in general good health and assessed by a clinician to have an intrauterine pregnancy less than 64 days L.M.P on the day mifepristone will be taken.
  • Participants must be eligible for medical abortion according to clinician and clinic standards.
  • In the United States, women only 18 years and older will be eligible to participate, unless the study site obtains a waiver to include minors.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Moldova, Republic of,   Nepal,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00994734
Other Study ID Numbers  ICMJE 1.2.3
Has Data Monitoring Committee Not Provided
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 Not Provided
PRS Account Gynuity Health Projects
Verification Date April 2012

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