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

Induced Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324519
• Other study ID #: 12-2005
• Status: Completed
• Phase: Phase 4
• First received: May 10, 2006
• Last updated: March 1, 2012
• Start date: February 2005
• Est. completion date: April 2007

Study information

• Verified date: March 2012
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• multiple gestation, previous uterine surgery, rupture of membranes, latex allergy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Induced Abortion
• Pregnancy Trimester, Second

Intervention

Device:
• Foley bulb

Drug:
• misoprostol

Locations

Country	Name	City	State
United States	Shands Hospital at the University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to vaginal delivery
Secondary	Rate of chorioamnionitis
Secondary	Rate of maternal fever
Secondary	Rate of postpartum hemorrhage