A Phase 2 interventional study of Intracervical Balloon Catheter and Oxytocin in Fetal Membranes, Premature Rupture and Induced Labor, sponsored by McMaster University. Terminated at 1 site in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2011-07-20.
Sponsored by McMaster University · Phase 2, Interventional, and Treatment
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.
142 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 27 are open to participants now.
This study's enrollment of 5 is below the median of 145 across 86 interventional studies indexed under Fetal Membranes, Premature Rupture.
Browse Fetal Membranes, Premature Rupture studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Induction of Labour with Oxytocin Alone
Drug: Oxytocin
Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction.
Procedure: Intracervical Balloon Catheter · Drug: Oxytocin
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.
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
This study is terminated, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fetal Membranes, Premature Rupture→
McMaster University