Premature Rupture of Mambrane and Unfavourable Cervix

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01615107
First received: April 23, 2012
Last updated: June 6, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Cervix; Insufficient Dilatation in Labor
Device: COOK RIPENENIG BALLOON+PITOCN
Drug: PITOCIN
Other: double balloonand oxytocin
Other: ballon and oxytocin
Procedure: double balloonand and oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between the Use of Standard Oxytocin Induction Protocol and the Double-balloon Catheter Device With Concurrent Oxytocin

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • PPROM/PROM to delivery interval [ Time Frame: 3year ] [ Designated as safety issue: Yes ]

    Time from rupture of mambrane to delivery

    From hospitalization until delivery



Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GROUP 1: Oxytocin infusion alone
GROUP 1: Oxytocin infusion alone
Drug: PITOCIN
: Oxytocin infusion alone (Standard Protocol
Other Name: 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 Name: BALLOON+PITOCN
Other: double balloonand oxytocin
balloonand oxytocin
Other Name: balloonand oxytocin
Other: ballon and oxytocin
double- balloon catheter device with concurrent oxytocin
Other Name: balloon catheter device with concurrent oxytocin
Procedure: double balloonand and oxytocin
balloon catheter device with concurrent oxytocin
Other Name: balloon catheter device with concurrent oxytocin

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

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615107

Contacts
Contact: Elad Mei-Dan, Dr 972-4-6188243

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38101
Contact: HILLEL YAFFE MEDICAL CENTER         
Principal Investigator: ELAD MEI-DAN, M.D.         
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: Elad Mei-Dan, DR Hillel Yaffe Medical Center
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01615107     History of Changes
Other Study ID Numbers: 0013-12-HYMC
Study First Received: April 23, 2012
Last Updated: June 6, 2012
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Dilatation, Pathologic
Pathological Conditions, Anatomical
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014