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Trial record 13 of 59 for:    abortion , gynuity

Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia

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ClinicalTrials.gov Identifier: NCT02398838
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : April 6, 2015
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Tracking Information
First Submitted Date  ICMJE September 12, 2014
First Posted Date  ICMJE March 26, 2015
Last Update Posted Date April 6, 2015
Study Start Date  ICMJE December 2009
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2015)
Proportion of abortions that are complete without surgical intervention (unit: percent) [ Time Frame: 15 days ]
Percentage of women with complete abortion without the need of a surgical intervention.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02398838 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2015)
Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent) [ Time Frame: 15 days ]
Woman's satisfaction with her medical abortion procedure and side effects experienced.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 20, 2015)
  • Proportion of women who select home-use of mifepristone [ Time Frame: 1 week ]
  • Proportion of women who select home-use of misoprostol [ Time Frame: 1 week ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia
Official Title  ICMJE Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia: A Study of 400 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 63 Days Gestation
Brief Summary This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in the eastern and western regions of the country of Georgia. It was hypothesized that home use of mifepristone and buccal administration of misoprostol would be both acceptable and efficacious.
Detailed Description The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone. Two days later they took 400 mcg buccal misoprostol, with the option of doing so in the clinic or at home. They underwent clinic follow-up 12-15 days after taking mifepristone to determine if their medical abortions were complete. The study assessed the regimen's efficacy, women's preferences regarding where to administer the medications, and the acceptability of buccal misoprostol and of side effects that accompanied women's medical abortions.
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 Abortion, First Trimester
Intervention  ICMJE
  • Drug: Home administration of 200 mg mifepristone
    Home administration of 200 mg mifepristone.
    Other Name: Penkrofton
  • Drug: Home or clinic administration of 400 mcg buccal misoprostol
    Home or clinic administration of 400 mcg buccal misoprostol
Study Arms  ICMJE
  • Experimental: Home administration of mifepristone
    Home administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.
    Interventions:
    • Drug: Home administration of 200 mg mifepristone
    • Drug: Home or clinic administration of 400 mcg buccal misoprostol
  • Active Comparator: Clinic administration of mifepristone
    Clinic administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.
    Intervention: Drug: Home or clinic administration of 400 mcg buccal misoprostol
Publications * Not Provided

*   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: March 20, 2015)
622
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years old
  • In good general health
  • Living or working close to the study site
  • Intrauterine pregnancy less than 64 days gestation
  • Willing and able to sign consent forms
  • Ready access to a telephone and emergency transportation
  • Willing to provide an address and/or telephone number for purposes of follow-up
  • Agree to comply with the study procedures and visit schedule

Exclusion Criteria:

  • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
  • IUD in place (IUD must be removed first)
  • Chronic renal failure
  • Concurrent long-term corticosteroid therapy
  • History of allergy to mifepristone, misoprostol or other prostaglandin
  • Hemorrhagic disorders or concurrent anticoagulant therapy
  • Inherited porphyrias
  • Other serious physical or mental health conditions
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Georgia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02398838
Other Study ID Numbers  ICMJE 1.2.4.5
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 April 2015

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