Randomized Trial Comparing Misoprostol and Foley Bulb for Pregnancy Termination in the Second Trimester

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00324519
First received: May 10, 2006
Last updated: March 1, 2012
Last verified: March 2012

May 10, 2006
March 1, 2012
February 2005
April 2007   (final data collection date for primary outcome measure)
Time to vaginal delivery
Same as current
Complete list of historical versions of study NCT00324519 on ClinicalTrials.gov Archive Site
  • Rate of chorioamnionitis
  • Rate of maternal fever
  • Rate of postpartum hemorrhage
Same as current
Not Provided
Not Provided
 
Randomized Trial Comparing Misoprostol and Foley Bulb for Pregnancy Termination in the Second Trimester
Randomized Trial Comparing Misoprostol and Foley Bulb for Pregnancy Termination in the Second Trimester

The purpose of this study is to compare two methods of pregnancy termination on the time to delivery in the second trimester.

Medical termination in the second trimester is performed for many indications. Successful termination is dependant on ripening of the cervix prior to labor induction. Multiple methods of cervical ripening and labor induction have been used for pregnancy termination in the second trimester. These two methods have different mechanisms of action. This study seeks to evaluate the effectiveness of these two methods.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pregnancy Trimester, Second
  • Induced Abortion
  • Device: Foley bulb
  • Drug: misoprostol
  • Active Comparator: Misoprostol Drug
    This is the misoprostol drug.
    Intervention: Drug: misoprostol
  • Experimental: The Foley Bulb
    This is the experimental portion to test the Foley Bulb.
    Intervention: Device: Foley bulb
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2007
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • indication for pregnancy termination, gestational age from 13-27 weeks

Exclusion Criteria:

  • multiple gestation, previous uterine surgery, rupture of membranes, latex allergy
Female
14 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00324519
12-2005
No
University of Florida
University of Florida
Not Provided
Principal Investigator: Keri A Baacke, MD University of Florida
University of Florida
March 2012

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