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Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP))

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ClinicalTrials.gov Identifier: NCT00969982
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : February 20, 2014
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Tracking Information
First Submitted Date  ICMJE August 31, 2009
First Posted Date  ICMJE September 2, 2009
Last Update Posted Date February 20, 2014
Study Start Date  ICMJE June 2009
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2009)
  • Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. [ Time Frame: 48 hours ]
  • Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus. [ Time Frame: 48 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2009)
  • Provision of additional interventions to manage excessive blood loss [ Time Frame: from start of treatment until discharge ]
  • Any heavy bleeding, uterine rupture, or infection requiring additional treatment [ Time Frame: start of treatment until discharge ]
  • Total dose of misoprostol. [ Time Frame: Assessed at time of complete abortion with study drug alone or when total maximum dose given. ]
  • Pain experienced by the woman as self-reported. [ Time Frame: Assessed during exit interview. ]
  • Women's acceptability of the assigned method [ Time Frame: Assessed at exit interview ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP))
Official Title  ICMJE Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial
Brief Summary The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 120 women in each country comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Abortion, Induced
Intervention  ICMJE
  • Drug: mifepristone+misoprostol
    single dose of 200 mg mifepristone followed 24 hours later by 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.
  • Drug: misoprostol+placebo
    placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.
Study Arms  ICMJE
  • Experimental: mifepristone+misoprostol
    200 mg mifepristone followed by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).
    Intervention: Drug: mifepristone+misoprostol
  • Active Comparator: misoprostol
    Placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion up to a maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).
    Intervention: Drug: misoprostol+placebo
Publications * Dabash R, Chelli H, Hajri S, Shochet T, Raghavan S, Winikoff B. A double-blind randomized controlled trial of mifepristone or placebo before buccal misoprostol for abortion at 14-21 weeks of pregnancy. Int J Gynaecol Obstet. 2015 Jul;130(1):40-4. doi: 10.1016/j.ijgo.2015.02.023. Epub 2015 Apr 11.

*   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: February 18, 2014)
238
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2009)
120
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound)
  • Meet legal criteria to obtain abortion
  • Present with closed cervical os and no vaginal bleeding
  • Live fetus at time of presentation for service
  • Have no contraindications to study procedures, according to provider
  • Be able to consent to procedure, either by reading consent document or by having consent document read to her
  • Be willing to follow study procedures

Exclusion Criteria:

  • Known previous transmural uterine incision
  • Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
  • Any contraindications to vaginal delivery, including placenta previa
  • Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, 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 Moldova, Republic of,   Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00969982
Other Study ID Numbers  ICMJE 1.4.1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Gynuity Health Projects
Original Responsible Party Dr. Beverly Winikoff, President, Gynuity Health Projects
Current Study Sponsor  ICMJE Gynuity Health Projects
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Beverly Winikoff Gynuity Health Projects
PRS Account Gynuity Health Projects
Verification Date February 2014

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