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

July 19, 2011 updated by: McMaster University

Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term: A Pilot Study.

The purpose of this study is to examine the feasibility of using intracervical balloon catheters for cervical ripening as part of labour induction in healthy, GBS-negative women with prelabour rupture of membranes at term.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled trial comparing two methods of induction of labour for pregnant, GBS-negative women presenting with prelabour rupture of membranes at term.

The intervention consists of the insertion of a double-balloon intracervical catheter at the time of induction, followed immediately by oxytocin infusion. The control consists of standard therapy: oxytocin induction. Our primary outcome is feasibility, and our secondary outcomes are length of first and second stages of labour, rate of vaginal delivery, intrapartum fever, chorioamnionitis, NICU admission, suspected or proven neonatal sepsis, or serious neonatal complication.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • St Joseph's Healthcare Hamilton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton Pregnancy
  • 37.0 and 41.0 gestational age
  • Confirmed Rupture of Membranes
  • Group B Streptococcus Negative
  • Cephalic Presentation
  • Absence of contractions for at least 60 minutes following rupture
  • Absence of contractions at time of enrolment

Exclusion Criteria:

  • Contraindication to Vaginal Delivery
  • Previous Uterine Surgery, including Caesarean Section
  • Previous Cerclage, Cone Biopsy, LEEP, or Cervical Surgery
  • Documented history of cervical incompetence
  • High Grade intraepithelial lesion, adenocarcinoma in situ, or invasive cervical cancer.
  • Immunosuppressed State
  • Active Vaginal Infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxytocin
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.
Experimental: Intracervical Catheter
Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction.
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.
Procedure: Intracervical Balloon Catheter
Intracervical insertion of an 80cc Double-Balloon Catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Intrapartum Fever
Time Frame: 48 Hours
48 Hours
Duration of Labour
Time Frame: 48 hours
48 hours
NICU Admission
Time Frame: 0-7 days postpartum
0-7 days postpartum
Chorioamnionitis
Time Frame: 48 Hours
48 Hours
Patient Satisfaction
Time Frame: 0-6 weeks Postpartum
0-6 weeks Postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

St. Joseph's Healthcare Hamilton

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 28, 2009

First Posted (Estimate)

April 30, 2009

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-3265

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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