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

NCT ID: NCT00324519

Last Updated: 2012-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pregnancy Trimester, Second Induced Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Misoprostol Drug

This is the misoprostol drug.

Group Type ACTIVE_COMPARATOR

misoprostol

Intervention Type DRUG

The Foley Bulb

This is the experimental portion to test the Foley Bulb.

Group Type EXPERIMENTAL

Foley bulb

Intervention Type DEVICE

Interventions

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Foley bulb

Intervention Type DEVICE

misoprostol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* multiple gestation, previous uterine surgery, rupture of membranes, latex allergy
Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keri A Baacke, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Shands Hospital at the University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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12-2005

Identifier Type: -

Identifier Source: org_study_id

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