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Premature Rupture of Mambrane and Unfavourable Cervix

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ClinicalTrials.gov Identifier: NCT01615107
Recruitment Status : Unknown
Verified April 2012 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 8, 2012
Last Update Posted : June 8, 2012
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2012
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. PPROM/PROM to delivery interval [ Time Frame: 3year ]

    Time from rupture of mambrane to delivery

    From hospitalization until delivery




Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01615107     History of Changes
Other Study ID Numbers: 0013-12-HYMC
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: June 8, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs