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Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term

NCT00890630 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2011-07-20

No results posted yet for this study

Summary

The purpose of this study is to examine the feasibility of using intracervical balloon catheters for cervical ripening as part of labour induction in healthy, GBS-negative women with prelabour rupture of membranes at term.

Conditions

  • Fetal Membranes, Premature Rupture
  • Induced Labor

Interventions

PROCEDURE

Intracervical Balloon Catheter

Intracervical insertion of an 80cc Double-Balloon Catheter.

DRUG

Oxytocin

IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min.

Sponsors & Collaborators

Principal Investigators

  • Dustin Costescu, MD, BSc · McMaster University, Department of Obstetrics and Gynaecology

  • Amie Cullimore, MD BSc BEd · McMaster University, Department of Obstetrics and Gynaecology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Canada

Study Locations

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Entities

Companies

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 NCT00890630 on ClinicalTrials.gov