Evaluation of CRB in PROM Patients

Premature Rupture of Fetal Membranes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736852
• Other study ID #: 09-014
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2020
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Premature Rupture of Fetal Membranes
• Rupture

Intervention

Device:
• CRB
Labor induction using the CRB

Drug:
• Pitocin
Labor induction using Pitocin

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Kosair Children's Hospital Maternal Fetal Medicine Specialists	Louisville	Kentucky
United States	University of South Florida	Tampa	Florida
United States	Tucson Medical Center (TMC)	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Cook Group Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of Labor	Time, in minutes, from the start of labor induction through delivery	Start of labor induction through delivery, an expected average of 6 hours
Primary	Incidence of Infection	number of patients with chorioamnionitis	Through hospital discharge, an expected average of 3 days