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Premature Rupture of Mambrane and Unfavourable Cervix

NCT01615107 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2012-06-08

No results posted yet for this study

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.

Conditions

  • Cervix; Insufficient Dilatation in Labor

Interventions

DEVICE

COOK RIPENENIG BALLOON+PITOCN

GROUP 2: insertion of the double balloon device and concurrent oxytocin administration.

DRUG

PITOCIN

: Oxytocin infusion alone (Standard Protocol

OTHER

double balloonand oxytocin

balloonand oxytocin

OTHER

ballon and oxytocin

double- balloon catheter device with concurrent oxytocin

PROCEDURE

double balloonand and oxytocin

balloon catheter device with concurrent oxytocin

Sponsors & Collaborators

  • Hillel Yaffe Medical Center

    lead OTHER_GOV

Principal Investigators

  • Elad Mei-Dan, DR · Hillel Yaffe Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01615107 on ClinicalTrials.gov