Premature Rupture of Mambrane and Unfavourable Cervix

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-07-31

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.

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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:

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

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Cervix; Insufficient Dilatation in Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GROUP 1: Oxytocin infusion alone

Group Type EXPERIMENTAL

PITOCIN

Intervention Type DRUG

: Oxytocin infusion alone (Standard Protocol

double balloonand oxytocin

insertion of the double balloon and oxytocin

Group Type EXPERIMENTAL

COOK RIPENENIG BALLOON+PITOCN

Intervention Type DEVICE

GROUP 2: insertion of the double balloon device and concurrent oxytocin administration.

double balloonand oxytocin

Intervention Type OTHER

balloonand oxytocin

ballon and oxytocin

Intervention Type OTHER

double- balloon catheter device with concurrent oxytocin

double balloonand and oxytocin

Intervention Type PROCEDURE

balloon catheter device with concurrent oxytocin

Interventions

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COOK RIPENENIG BALLOON+PITOCN

GROUP 2: insertion of the double balloon device and concurrent oxytocin administration.

Intervention Type DEVICE

PITOCIN

: Oxytocin infusion alone (Standard Protocol

Intervention Type DRUG

double balloonand oxytocin

balloonand oxytocin

Intervention Type OTHER

ballon and oxytocin

double- balloon catheter device with concurrent oxytocin

Intervention Type OTHER

double balloonand and oxytocin

balloon catheter device with concurrent oxytocin

Intervention Type PROCEDURE

Other Intervention Names

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BALLOON+PITOCN Oxytocin infusion alone balloonand oxytocin balloon catheter device with concurrent oxytocin balloon catheter device with concurrent oxytocin

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes