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

University of Florida

Status and phase: Completed; Phase 4

Conditions: Induced Abortion; Pregnancy Trimester, Second

Treatments: Drug: misoprostol; Device: Foley bulb

Study type: Interventional

Funder types: Other

Identifiers

NCT00324519

12-2005

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 14 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Misoprostol Drug

Active Comparator group

Description:

This is the misoprostol drug.

Treatment:

Drug: misoprostol

The Foley Bulb

Experimental group

Description:

This is the experimental portion to test the Foley Bulb.

Treatment:

Device: Foley bulb