Premature Rupture of Mambrane and Unfavourable Cervix

June 6, 2012 updated by: Hillel Yaffe Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Elad Mei-Dan, Dr
  • Phone Number: 972-4-6188243

Study Locations

  • Israel
      • Hadera, Israel, 38101
        • Hillel Yaffe Medical Center
        • Contact:
          • Hillel Yaffe Medical Center
        • Principal Investigator:
          • ELAD MEI-DAN, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPROM/PROM to delivery interval
Time Frame: 3year

Time from rupture of mambrane to delivery

From hospitalization until delivery
3year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Elad Mei-Dan, DR, Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimate)

June 8, 2012

Study Record Updates

Last Update Posted (Estimate)

June 8, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0013-12-HYMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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