Evaluation of CRB in PROM Patients

NCT ID: NCT01736852

Last Updated: 2020-10-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2018-12-31

Brief Summary

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The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).

Detailed Description

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Conditions

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Premature Rupture of Fetal Membranes

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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CRB plus Pitocin

Group Type EXPERIMENTAL

CRB

Intervention Type DEVICE

Labor induction using the CRB

Pitocin

Intervention Type DRUG

Labor induction using Pitocin

Pitocin

Group Type ACTIVE_COMPARATOR

Pitocin

Intervention Type DRUG

Labor induction using Pitocin

Interventions

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CRB

Labor induction using the CRB

Intervention Type DEVICE

Pitocin

Labor induction using Pitocin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* PROM not in labor

Exclusion Criteria

* Contraindication to vaginal delivery
* Contraindication to labor induction
* Abnormal fetal heart-rate patterns
* Maternal heart disease
* Severe maternal hypertension
* Pelvic structural abnormality
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hugh Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Watching Over Mothers and Babies (WOMB)

Locations

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Tucson Medical Center (TMC)

Tucson, Arizona, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Kosair Children's Hospital Maternal Fetal Medicine Specialists

Louisville, Kentucky, United States

Site Status

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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09-014

Identifier Type: -

Identifier Source: org_study_id

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