Back to results

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

Primary Purpose

Fetal Membranes, Premature Rupture, Induced Labor

Status

Terminated

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Intracervical Balloon Catheter

Oxytocin

About this trial

This is an interventional treatment trial for Fetal Membranes, Premature Rupture

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

St Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Oxytocin

Intracervical Catheter

Arm Description

Induction of Labour with Oxytocin Alone

Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction.

Outcomes

Primary Outcome Measures

Feasibility

Secondary Outcome Measures

Intrapartum Fever

Duration of Labour

NICU Admission

Chorioamnionitis

Patient Satisfaction

Full Information

NCT ID

NCT00890630

First Posted

April 27, 2009

Last Updated

July 19, 2011

Sponsor

McMaster University

Collaborators

St. Joseph's Healthcare Hamilton

1. Study Identification

Unique Protocol Identification Number

NCT00890630

Brief Title

Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term

Acronym

IC-PROM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Terminated

Why Stopped

Inadequate Patient Recruitment.

Study Start Date

April 2010 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

McMaster University

Collaborators

St. Joseph's Healthcare Hamilton

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fetal Membranes, Premature Rupture, Induced Labor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oxytocin

Arm Type

Active Comparator

Arm Description

Induction of Labour with Oxytocin Alone

Arm Title

Intracervical Catheter

Arm Type

Experimental

Arm Description

Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction.

Intervention Type

Procedure

Intervention Name(s)

Intracervical Balloon Catheter

Intervention Description

Intracervical insertion of an 80cc Double-Balloon Catheter.

Intervention Type

Drug

Intervention Name(s)

Oxytocin

Intervention Description

IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min.

Primary Outcome Measure Information:

Title

Feasibility

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Intrapartum Fever

Time Frame

48 Hours

Title

Duration of Labour

Time Frame

48 hours

Title

NICU Admission

Time Frame

0-7 days postpartum

Title

Chorioamnionitis

Time Frame

48 Hours

Title

Patient Satisfaction

Time Frame

0-6 weeks Postpartum

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dustin Costescu, MD, BSc

Organizational Affiliation

McMaster University, Department of Obstetrics and Gynaecology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Amie Cullimore, MD BSc BEd

Organizational Affiliation

McMaster University, Department of Obstetrics and Gynaecology

Official's Role

Principal Investigator

Facility Information:

Facility Name

St Joseph's Healthcare Hamilton

City

Hamilton

State/Province

Ontario

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

23766376

Citation

Costescu DJ, Cullimore AJ. Lessons learned from a resident-led clinical trial in obstetrics. Clin Trials. 2013 Aug;10(4):612-6. doi: 10.1177/1740774513492045. Epub 2013 Jun 13.

Results Reference

derived

Learn more about this trial

Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term

We'll reach out to this number within 24 hrs