Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation

NCT ID: NCT00325026

Last Updated: 2012-03-02

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

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-04-30

Brief Summary

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The purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation.

Detailed Description

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Labor induction for the preterm gestation is indicated for various maternal and fetal indications. The preterm cervix, however, is frequently not favorable for induction. Multiple methods have been evaluated in the term gestation. As these comparison studies have not included the preterm gestation, this study seeks to evaluate these two methods in terms of safety, efficacy and time to delivery.

Conditions

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Premature Birth Cervical Ripening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Misoprostol

Intervention Type DRUG

Foley bulb

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* singleton gestation, gestational age 23-35 weeks, indication for induction

Exclusion Criteria

* multiple gestation, non-cephalic presentation, previous uterine surgery, rupture of membranes, intrauterine fetal death
Minimum Eligible Age

18 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

References

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de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

Reference Type DERIVED
PMID: 36996264 (View on PubMed)

Other Identifiers

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594-2004

Identifier Type: -

Identifier Source: org_study_id

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