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The Extended Gestational Age Medical Abortion Study

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: NCT00997347
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : July 2, 2012
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Tracking Information
First Submitted Date  ICMJE October 1, 2009
First Posted Date  ICMJE October 19, 2009
Last Update Posted Date July 2, 2012
Study Start Date  ICMJE July 2009
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2011)
Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion [ Time Frame: 7-36 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2009)
Proportion of successful medical abortions without need for surgical intervention [ Time Frame: 6-9 months and 12-15 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2011)
  • Proportion of individual side effects experienced by participants [ Time Frame: 7-14 days ]
  • Proportion of women who determined method acceptable (i.e., overall acceptability of method, time to abortion completion, bleeding, side effects, and pain) [ Time Frame: 7-14 days ]
  • Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began [ Time Frame: 7-14 days ]
  • Average number of missed days of work or school due to the abortion procedure [ Time Frame: 7-14 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2009)
  • Proportion of individual side effects experienced by participants [ Time Frame: 6-9 months and 12-15 months ]
  • Proportion of women who determined method acceptable (i.e., overall acceptability of method, time to abortion completion, bleeding, side effects, and pain) [ Time Frame: 12-15 months ]
  • Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began [ Time Frame: 12-15 months ]
  • Average number of missed days of work or school due to the abortion procedure [ Time Frame: 12-15 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Extended Gestational Age Medical Abortion Study
Official Title  ICMJE The Extended Gestational Age Medical Abortion Study: The Effectiveness of Medical Abortion With Mifepristone and Misoprostol at 57-63 Days Versus 64-70 Days Gestation
Brief Summary This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Medical Abortion
Intervention  ICMJE Drug: Mifepristone and misoprostol

200 mg oral mifepristone

800 mcg buccal misoprostol or 400 mcg sublingual misoprostol 24-48 hours after mifepristone

Study Arms  ICMJE
  • Experimental: 64-70 days' gestational age
    Women whose pregnancies are estimated to have a gestational age of 64-70 days
    Intervention: Drug: Mifepristone and misoprostol
  • No Intervention: 57-63 days' gestational age
    Women whose pregnancies are estimated to have a gestational age of 57-63 days. (Women in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range.)
Publications * Winikoff B, Dzuba IG, Chong E, Goldberg AB, Lichtenberg ES, Ball C, Dean G, Sacks D, Crowden WA, Swica Y. Extending outpatient medical abortion services through 70 days of gestational age. Obstet Gynecol. 2012 Nov;120(5):1070-6. doi: http://10.1097/AOG.0b013e31826c315f.

*   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 16, 2009)
1400
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • intrauterine pregnancy of greater than 56 days and less than 71 days
  • eligible for medical abortion according to study doctor assessment
  • willing and able to sign consent forms
  • speak English or Spanish (in US sites); speak the local language(s) (in international sites)
  • agree to comply with the study procedures and visit schedule
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 Georgia,   India,   Tunisia,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00997347
Other Study ID Numbers  ICMJE 1.2.2
Has Data Monitoring Committee Yes
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: Yael Swica, MD, MPH Gynuity Health Projects
Principal Investigator: Hillary Bracken, PhD Gynuity Health Projects
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
PRS Account Gynuity Health Projects
Verification Date June 2012

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