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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00969982
First received: August 31, 2009
Last updated: February 18, 2014
Last verified: February 2014

August 31, 2009
February 18, 2014
June 2009
June 2013   (final data collection date for primary outcome measure)
  • Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00969982 on ClinicalTrials.gov Archive Site
  • Provision of additional interventions to manage excessive blood loss [ Time Frame: from start of treatment until discharge ] [ Designated as safety issue: No ]
  • Any heavy bleeding, uterine rupture, or infection requiring additional treatment [ Time Frame: start of treatment until discharge ] [ Designated as safety issue: No ]
  • Total dose of misoprostol. [ Time Frame: Assessed at time of complete abortion with study drug alone or when total maximum dose given. ] [ Designated as safety issue: No ]
  • Pain experienced by the woman as self-reported. [ Time Frame: Assessed during exit interview. ] [ Designated as safety issue: No ]
  • Women's acceptability of the assigned method [ Time Frame: Assessed at exit interview ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP))
Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Abortion, Induced
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
238
June 2013
June 2013   (final data collection date for primary outcome measure)

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)
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Moldova, Republic of,   Tunisia
 
NCT00969982
1.4.1
No
Gynuity Health Projects
Gynuity Health Projects
Not Provided
Principal Investigator: Beverly Winikoff Gynuity Health Projects
Gynuity Health Projects
February 2014

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