Premature Rupture of Mambrane and Unfavourable Cervix

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Cervix; Insufficient Dilatation in Labor

Treatments: Procedure: double balloonand and oxytocin; Drug: PITOCIN; Other: double balloonand oxytocin; Other: ballon and oxytocin; Device: COOK RIPENENIG BALLOON+PITOCN

Study type: Interventional

Funder types: Other

Identifiers

NCT01615107

0013-12-HYMC

Details and patient eligibility

About

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.

Full 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

Enrollment: 300 estimated patients

Sex: Female

Ages: 16 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

GROUP 1: Oxytocin infusion alone

Experimental group

Description:

GROUP 1: Oxytocin infusion alone

Treatment:

Drug: PITOCIN

double balloonand oxytocin

Experimental group

Description:

insertion of the double balloon and oxytocin

Treatment:

Device: COOK RIPENENIG BALLOON+PITOCN

Other: ballon and oxytocin

Other: double balloonand oxytocin

Procedure: double balloonand and oxytocin