Premature Rupture of Mambrane and Unfavourable Cervix | NCT01615107

Studies
Premature Rupture of Mambrane and Unfavourable Cervix

NCT01615107

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Jun 8, 2012Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Cervix; Insufficient Dilatation in Labor

Interventions

COOK RIPENENIG BALLOON+PITOCN
PITOCIN
double balloonand oxytocin
ballon and oxytocin
double balloonand and oxytocin

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jul 2014Estimated

Completion Date

Jul 2014Estimated

First Submitted Date

Apr 23, 2012

First Submission Date that Met QC Criteria

Jun 6, 2012

First Posted Date

Jun 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2012

Last Update Posted Date

Jun 8, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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:

The fetal heart pattern for the presence or absence of decelerations and
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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GROUP 1: Oxytocin infusion alone	Experimental	GROUP 1: Oxytocin infusion alone	Drug: PITOCIN
double balloonand oxytocin	Experimental	insertion of the double balloon and oxytocin	Device: COOK RIPENENIG BALLOON+PITOCN Other: double balloonand oxytocin Other: ballon and oxytocin Procedure: double balloonand and oxytocin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COOK RIPENENIG BALLOON+PITOCN	Device	GROUP 2: insertion of the double balloon device and concurrent oxytocin administration.	double balloonand oxytocin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PPROM/PROM to delivery interval	Time from rupture of mambrane to delivery From hospitalization until delivery	3year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed to be pregnant with PROM at > 34 week
Found to have a Bishop score of 4 points or less.
Diagnosed as having a singleto
Willingness to comply with the protocol for the duration of the study.
Have signed an informed consent.

Exclusion Criteria:

Any contraindication for a vaginal deliver
Regular uterine contractn
Evidence of chorio-amonitis
Previous cesarean section or presence of any uterine scar.
Suspected placental abruption or presence of a significant hemorrhage.
Non-reassuring fetal statu

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elad Mei-Dan, Dr	Contact	972-4-6188243

Overall Officials

Name	Affiliation	Role
Elad Mei-Dan, DR	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38101	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36996264	Derived	de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones