Premature Rupture of Mambrane and Unfavourable Cervix

Study Overview
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Brief Summary
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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
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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: The fetal heart pattern for the presence or absence of decelerations and 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

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

Conditions
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Cervix; Insufficient Dilatation in Labor

Intervention / Treatment
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* Device: COOK RIPENENIG BALLOON+PITOCN
* Drug: PITOCIN
* Other: double balloonand oxytocin
* Other: ballon and oxytocin
* Procedure: double balloonand and oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed to be pregnant with PROM at > 34 week Found to have a Bishop score of 4 points or less. Diagnosed as having a singleto Willingness to comply with the protocol for the duration of the study. Have signed an informed consent. Exclusion Criteria: Any contraindication for a vaginal deliver Regular uterine contractn Evidence of chorio-amonitis Previous cesarean section or presence of any uterine scar. Suspected placental abruption or presence of a significant hemorrhage. Non-reassuring fetal statu

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GROUP 1: Oxytocin infusion alone<br>GROUP 1: Oxytocin infusion alone | Drug: PITOCIN<br>* : Oxytocin infusion alone (Standard Protocol<br>* Other names: Oxytocin infusion alone;|
| Experimental: double balloonand oxytocin<br>insertion of the double balloon and oxytocin | Device: COOK RIPENENIG BALLOON+PITOCN<br>* GROUP 2: insertion of the double balloon device and concurrent oxytocin administration.<br>* Other names: BALLOON+PITOCN;Other: double balloonand oxytocin<br>* balloonand oxytocin<br>* Other names: balloonand oxytocin;Other: ballon and oxytocin<br>* double- balloon catheter device with concurrent oxytocin<br>* Other names: balloon catheter device with concurrent oxytocin;Procedure: double balloonand and oxytocin<br>* balloon catheter device with concurrent oxytocin<br>* Other names: balloon catheter device with concurrent oxytocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPROM/PROM to delivery interval | Time from rupture of mambrane to delivery From hospitalization until delivery | 3year |