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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
5
Intracervical insertion of an 80cc Double-Balloon Catheter.
IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min.
St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Feasibility
Time frame: 48 hours
Intrapartum Fever
Time frame: 48 Hours
Duration of Labour
Time frame: 48 hours
NICU Admission
Time frame: 0-7 days postpartum
Chorioamnionitis
Time frame: 48 Hours
Patient Satisfaction
Time frame: 0-6 weeks Postpartum
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