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
  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: 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

Ages Eligible for Study:   14 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00324519     History of Changes
Other Study ID Numbers: 12-2005
Study First Received: May 10, 2006
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on September 16, 2014