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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fetal Membranes, Premature Rupture, Induced Labor

Intervention / Treatment
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* Procedure: Intracervical Balloon Catheter
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin<br>Induction of Labour with Oxytocin Alone | Drug: Oxytocin<br>* IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min.<br>|
| Experimental: Intracervical Catheter<br>Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction. | Procedure: Intracervical Balloon Catheter<br>* Intracervical insertion of an 80cc Double-Balloon Catheter.<br>Drug: Oxytocin<br>* IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility |  | 48 hours | 

Secondary Outcome Measures

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