Premature Rupture of Mambrane and Unfavourable Cervix

Cervix; Insufficient Dilatation in Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01615107
• Other study ID #: 0013-12-HYMC
• Status: Not yet recruiting
• Phase: N/A
• First received: April 23, 2012
• Last updated: June 6, 2012
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: April 2012
• Source: Hillel Yaffe Medical Center
• Contact: Elad Mei-Dan, Dr
• Phone: 972-4-6188243
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervix; Insufficient Dilatation in Labor

Intervention

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
• ballon and oxytocin
double- balloon catheter device with concurrent oxytocin

Procedure:
• double balloonand and oxytocin
balloon catheter device with concurrent oxytocin

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PPROM/PROM to delivery interval	Time from rupture of mambrane to delivery; From hospitalization until delivery	3year	Yes