Use of Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term - Full Text View

Use of Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term (ICI-PROM)

This study is not yet open for participant recruitment.

Verified by McMaster University, April 2009

First Received: April 27, 2009 Last Updated: April 28, 2009 History of Changes

Sponsors and Collaborators:	McMaster University Hamilton Health Sciences
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00890630

Purpose

The purpose of this study is to examine whether or not it is feasible to use intracervical balloon catheters as part of labour induction in healthy pregnant women with prelabour rupture of membranes at term.

Condition	Intervention	Phase
Fetal Membranes, Premature Rupture Induced Labor	Procedure: Intracervical Foley Catheter Drug: Oxytocin	Phase II

Drug Information available for: Oxytocin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Use of Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term: A Feasibility Study.

Further study details as provided by McMaster University:

Primary Outcome Measures:

Rate of Caesarean Section [ Time Frame: 48 Hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intrapartum Fever [ Time Frame: 48 Hours ] [ Designated as safety issue: Yes ]
Duration of Labour [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
NICU Admission [ Time Frame: 0-7 days postpartum ] [ Designated as safety issue: Yes ]
Chorioamnionitis [ Time Frame: 48 Hours ] [ Designated as safety issue: Yes ]
Patient Satisfaction [ Time Frame: 0-6 weeks Postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	July 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Oxytocin: Active Comparator Induction of Labour with Oxytocin Alone	Drug: Oxytocin IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min.
Intracervical Catheter: Experimental Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction.	Procedure: Intracervical Foley Catheter Intracervical insertion of a 20Fr 50cc Balloon Catheter. Drug: Oxytocin IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Between 37 and 41 gestational weeks
Confirmed Rupture of Membranes
Group B Streptococcus Negative
Cephalic Presentation

Exclusion Criteria:

Contraindication to Vaginal Delivery
Immunosuppressed State
Active Vaginal or Uterine Infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890630

Contacts

Contact: Dustin Costescu, MD, BSc

905-521-5070 ext 6536

costesd@mcmaster.ca

Locations

Canada, Ontario
McMaster University Medical Centre
Hamilton, Ontario, Canada
St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada

Sponsors and Collaborators

McMaster University

Hamilton Health Sciences

Investigators

Principal Investigator:	Dustin Costescu, MD, BSc	McMaster University, Department of Obstetrics and Gynaecology
Principal Investigator:	Amie Cullimore, MD BSc BEd MSC	McMaster University, Department of Obstetrics and Gynaecology

More Information

No publications provided

Responsible Party:	Faculty of Health Sciences, McMaster University ( Dr. Amie Cullimore )
Study ID Numbers:	McMOB-001
Study First Received:	April 27, 2009
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00890630 History of Changes
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Pregnancy Complications
Wounds and Injuries
Obstetric Labor Complications
Disorders of Environmental Origin

Rupture
Fetal Membranes, Premature Rupture
Oxytocin

Additional relevant MeSH terms:

Pregnancy Complications
Oxytocics
Therapeutic Uses
Physiological Effects of Drugs
Wounds and Injuries
Obstetric Labor Complications

Disorders of Environmental Origin
Rupture
Reproductive Control Agents
Fetal Membranes, Premature Rupture
Pharmacologic Actions
Oxytocin

ClinicalTrials.gov processed this record on May 07, 2009