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

Phase 2

Terminated

• Conditions: Fetal Membranes, Premature Rupture; Induced Labor
• Interventions: Procedure: Intracervical Balloon Catheter; Drug: Oxytocin

• Registration Number: NCT00890630
• Lead Sponsor: McMaster University

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.

Study Timeline

• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-30
• Study Start: 2010-04
• Status Verified: 2011-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracervical Catheter	Intracervical Balloon Catheter	Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction.
Oxytocin	Oxytocin	Induction of Labour with Oxytocin Alone
Intracervical Catheter	Oxytocin	Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction.

Primary Outcome Measures

Name	Time	Method
Feasibility	48 hours

Secondary Outcome Measures

Name	Time	Method
Duration of Labour	48 hours
NICU Admission	0-7 days postpartum
Chorioamnionitis	48 Hours
Patient Satisfaction	0-6 weeks Postpartum
Intrapartum Fever	48 Hours

Trial Locations

Locations (1)

St Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada