Second Trimester Labor Induction

This study has been terminated.
Sponsor:
Collaborator:
University of Maryland
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00592215
First received: December 31, 2007
Last updated: June 9, 2009
Last verified: June 2009

December 31, 2007
June 9, 2009
March 2008
April 2010   (final data collection date for primary outcome measure)
Abortion rate [ Time Frame: 8 hours after misoprostol administration ] [ Designated as safety issue: No ]
Abortion rate [ Time Frame: 12 hours after misoprostol administration ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00592215 on ClinicalTrials.gov Archive Site
Not Provided
Abortion rate [ Time Frame: 24 hours after misoprostol administration ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Second Trimester Labor Induction
A Pilot Study of Mifepristone Followed by Misoprostol in Women Undergoing Second Trimester Abortion

A superior second trimester medical abortion regimen has not been identified. Studies suggest that a regimen of mifepristone and misoprostol given 36 to 48 hours apart has the shortest median induction-to-abortion interval, highest 24-hour abortion rate, and low rates of adverse events. Narrowing the interval between the two medications without clinically reducing effectiveness may increase access and acceptability for patients and reduce costs. Data from studies on first trimester abortions suggest that the 6 to 8 hour interval between mifepristone and misoprostol is as efficacious as the 36 to 48 hour interval. There are no studies on shorter intervals with same day administration between mifepristone and misoprostol in second trimester abortions.

The primary objective is to assess the efficacy of the combined mifepristone/misoprostol regimen for abortions between 17 0/7 and 23 6/7 weeks' gestation using an interval of 6 to 8 hours between the two medications.

Not Provided
Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Second Trimester Labor Induction
Drug: Experimental (mifepristone and misoprostol)
Mifepristone 200mg followed by labor induction with misoprostol after 6-8 hours
Experimental: A
Mifepristone followed by labor induction with misoprostol after 6-8 hours
Intervention: Drug: Experimental (mifepristone and misoprostol)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
0
October 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • English-speaking women
  • 18 years of age and above
  • Voluntarily choose to undergo pregnancy termination via labor induction
  • An ultrasound-confirmed singleton intrauterine pregnancy between 17 0/7 and 23 6/7 weeks gestation
  • Able to provide written consent

Exclusion Criteria:

  • Premature rupture of membranes
  • Preterm labor
  • Intrauterine fetal demise
  • Chronic systemic corticosteroid use or adrenal disease
  • Hypersensitivity to prostaglandins
  • Cardiovascular disease such as angina, valvular disease, arrhythmia, cardiac failure
  • Known coagulopathy or treatment with anticoagulants
  • Prior caesarean delivery or myomectomy
  • Placenta previa
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00592215
NA_00010268, 2007-663
Yes
Johns Hopkins University
Johns Hopkins University
University of Maryland
Not Provided
Johns Hopkins University
June 2009

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