Premature Rupture of Mambrane and Unfavourable Cervix

Not Applicable

• Conditions: Cervix; Insufficient Dilatation in Labor
• Interventions: Drug: PITOCIN; Device: COOK RIPENENIG BALLOON+PITOCN; Other: double balloonand oxytocin; Other: ballon and oxytocin; Procedure: double balloonand and oxytocin

• Registration Number: NCT01615107
• Lead Sponsor: Hillel Yaffe Medical Center

Brief 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

Study Timeline

• Status Verified: 2012-04
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-06-06
• Last Update Submitted: 2012-06-06
• Study First Posted: 2012-06-08
• Last Update Posted: 2012-06-08
• Study Start: 2012-07
• Primary Completion: 2014-07
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. Diagnosed to be pregnant with PROM at > 34 week
2. Found to have a Bishop score of 4 points or less.
3. Diagnosed as having a singleto
4. Willingness to comply with the protocol for the duration of the study.
5. Have signed an informed consent.

Exclusion Criteria

1. Any contraindication for a vaginal deliver
2. Regular uterine contractn
3. Evidence of chorio-amonitis
4. Previous cesarean section or presence of any uterine scar.
5. Suspected placental abruption or presence of a significant hemorrhage.
6. Non-reassuring fetal statu

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP 1: Oxytocin infusion alone	PITOCIN	GROUP 1: Oxytocin infusion alone
double balloonand oxytocin	COOK RIPENENIG BALLOON+PITOCN	insertion of the double balloon and oxytocin
double balloonand oxytocin	double balloonand oxytocin	insertion of the double balloon and oxytocin
double balloonand oxytocin	ballon and oxytocin	insertion of the double balloon and oxytocin
double balloonand oxytocin	double balloonand and oxytocin	insertion of the double balloon and oxytocin

Primary Outcome Measures

Name	Time	Method
PPROM/PROM to delivery interval	3year	Time from rupture of mambrane to delivery; From hospitalization until delivery

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel