NCT01615107

Premature Rupture of Mambrane and Unfavourable Cervix

Comparison Between the Use of Standard Oxytocin Induction Protocol and the Double-balloon Catheter Device With Concurrent Oxytocin

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Hillel Yaffe Medical Center · Other Government
• Sex: Female
• Age: 16 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The paucity of published data concerning the issue of mechanical labor induction in the setting of Term PROM has led us to undertake the present clinical trial. This study is designed to compare the efficacy and safety of the standard Oxytocin induction protocol with the double-balloon catheter device with concurrent oxytocin administration in patients with Term PROM and unfavorable cervical conditions.

Detailed description

This will be a prospective randomised trial. Two hundred pregnant women with term PROM and an unfavourable cervix (Bishop Score ≤ 4) are expected to be entered into the study (see statistical analysis below). All eligible women will be presented with the study protocol by a study coordinator. Women interested in participating will read and sign the informed consent. Subsequently, the following screening medical procedures will be completed: medical and gynecological history, physical and vaginal examination, ultrasonography to: (i) Confirm fetal vertex presentation, (ii) Exclude placenta previa and (iii) Assess cervical length and posterior cervical angle. (iv) Asses bio-physical profile score A non-stress test will be performed in order to monitor: 1. The fetal heart pattern for the presence or absence of decelerations and 2. The presence of uterine contractions. All women will undergo a pelvic examination by a staff member to obtain an initial Bishop score. If the patient will be determined eligible for study entry, and following the informed consent, randomisation into the following groups will take place: GROUP 1: Oxytocin infusion alone (Standard Protocol). GROUP 2: insertion of the double balloon device and concurrent oxytocin administration. GROUP 3: Expectant management

Conditions

• Cervix; Insufficient Dilatation in Labor

Interventions

Type	Name	Description
DEVICE	COOK RIPENENIG BALLOON+PITOCN	GROUP 2: insertion of the double balloon device and concurrent oxytocin administration.
DRUG	PITOCIN	: Oxytocin infusion alone (Standard Protocol
OTHER	double balloonand oxytocin	balloonand oxytocin
OTHER	ballon and oxytocin	double- balloon catheter device with concurrent oxytocin
PROCEDURE	double balloonand and oxytocin	balloon catheter device with concurrent oxytocin

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-06-08
• Last updated: 2012-06-08

Locations

1 site across 1 country: Israel