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

McMaster University

Status and phase: Terminated; Phase 2

Conditions: Fetal Membranes, Premature Rupture; Induced Labor

Treatments: Drug: Oxytocin; Procedure: Intracervical Balloon Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT00890630

09-3265

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: Female

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5 participants in 2 patient groups

Oxytocin

Active Comparator group

Description:

Induction of Labour with Oxytocin Alone

Treatment:

Drug: Oxytocin

Intracervical Catheter

Experimental group

Description:

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

Treatment:

Procedure: Intracervical Balloon Catheter

Drug: Oxytocin