Evaluation of CRB in PROM Patients

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).

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Key information

Conditions

Premature Rupture of Fetal Membranes Female Urogenital Diseases and Pregnancy Complications Fetal Membranes, Premature Rupture Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tucson Medical Center (TMC), Tucson, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRB

Device

Labor induction using the CRB

Pitocin

Drug

Labor induction using Pitocin

Primary outcomes

Time of Labor

Time frame: Start of labor induction through delivery, an expected average of 6 hours

Time, in minutes, from the start of labor induction through delivery
Incidence of Infection

Time frame: Through hospital discharge, an expected average of 3 days

number of patients with chorioamnionitis

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

Randomized Study to Compare the Cook Cervical Ripening Balloon (CRB) Plus Pitocin to Pitocin Alone in Premature Rupture of Membranes (PROM) Patients

Important dates

Study start: 2012
Primary completion: 2018
Study completion: 2018
First posted: Nov 29, 2012
Registry last updated: Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed