Premature Rupture of Mambrane and Unfavourable Cervix
Comparison Between the Use of Standard Oxytocin Induction Protocol and the Double-balloon Catheter Device With Concurrent Oxytocin
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2012
CompletedFirst Posted
Study publicly available on registry
June 8, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJune 8, 2012
April 1, 2012
2 years
April 23, 2012
June 6, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
PPROM/PROM to delivery interval
Time from rupture of mambrane to delivery From hospitalization until delivery
3year
Study Arms (2)
GROUP 1: Oxytocin infusion alone
EXPERIMENTALGROUP 1: Oxytocin infusion alone
double balloonand oxytocin
EXPERIMENTALinsertion of the double balloon and oxytocin
Interventions
GROUP 2: insertion of the double balloon device and concurrent oxytocin administration.
: Oxytocin infusion alone (Standard Protocol
balloonand oxytocin
double- balloon catheter device with concurrent oxytocin
balloon catheter device with concurrent oxytocin
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hillel Yaffe Medical Center
Hadera, 38101, Israel
Related Publications (1)
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.
PMID: 36996264DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elad Mei-Dan, DR
Hillel Yaffe Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2012
First Posted
June 8, 2012
Study Start
July 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
June 8, 2012
Record last verified: 2012-04