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

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ClinicalTrials.gov Identifier: NCT00324519
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : March 5, 2012
Sponsor:
Information provided by (Responsible Party):
University of Florida

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

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : February 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Time to vaginal delivery

Secondary Outcome Measures :
  1. Rate of chorioamnionitis
  2. Rate of maternal fever
  3. Rate of postpartum hemorrhage


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

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

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00324519     History of Changes
Other Study ID Numbers: 12-2005
First Posted: May 11, 2006    Key Record Dates
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