NCT00890630

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Fetal Membranes, Premature Rupture
• Induced Labor

Interventions

Type	Name	Description
PROCEDURE	Intracervical Balloon Catheter	Intracervical insertion of an 80cc Double-Balloon Catheter.
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.

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-04-30
• Last updated: 2011-07-20

Locations

1 site across 1 country: Canada