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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00324519
First Posted: May 11, 2006
Last Update Posted: March 5, 2012
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.
Information provided by (Responsible Party):
University of Florida
  Purpose
The purpose of this study is to compare two methods of pregnancy termination on the time to delivery in the second trimester.

Condition Intervention Phase
Pregnancy Trimester, Second Induced Abortion Device: Foley bulb Drug: misoprostol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Misoprostol and Foley Bulb for Pregnancy Termination in the Second Trimester

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Time to vaginal delivery

Secondary Outcome Measures:
  • Rate of chorioamnionitis
  • Rate of maternal fever
  • Rate of postpartum hemorrhage

Enrollment: 30
Study Start Date: February 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Misoprostol Drug
This is the misoprostol drug.
Drug: misoprostol
Experimental: The Foley Bulb
This is the experimental portion to test the Foley Bulb.
Device: Foley bulb

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • multiple gestation, previous uterine surgery, rupture of membranes, latex allergy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324519


Locations
United States, Florida
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Keri A Baacke, MD University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00324519     History of Changes
Other Study ID Numbers: 12-2005
First Submitted: May 10, 2006
First Posted: May 11, 2006
Last Update Posted: March 5, 2012
Last Verified: March 2012

Keywords provided by University of Florida:
second trimester
pregnancy termination
misoprostol
foley bulb

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics