Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term (IC-PROM)

This study has been terminated.
(Inadequate Patient Recruitment.)
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00890630
First received: April 27, 2009
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Fetal Membranes, Premature Rupture
Induced Labor
Procedure: Intracervical Balloon Catheter
Drug: Oxytocin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term: A Pilot Study.

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intrapartum Fever [ Time Frame: 48 Hours ] [ Designated as safety issue: Yes ]
  • Duration of Labour [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • NICU Admission [ Time Frame: 0-7 days postpartum ] [ Designated as safety issue: Yes ]
  • Chorioamnionitis [ Time Frame: 48 Hours ] [ Designated as safety issue: Yes ]
  • Patient Satisfaction [ Time Frame: 0-6 weeks Postpartum ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: April 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxytocin
Induction of Labour with Oxytocin Alone
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.
Experimental: Intracervical Catheter
Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction.
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.

Detailed Description:

This is a randomized controlled trial comparing two methods of induction of labour for pregnant, GBS-negative women presenting with prelabour rupture of membranes at term.

The intervention consists of the insertion of a double-balloon intracervical catheter at the time of induction, followed immediately by oxytocin infusion. The control consists of standard therapy: oxytocin induction. Our primary outcome is feasibility, and our secondary outcomes are length of first and second stages of labour, rate of vaginal delivery, intrapartum fever, chorioamnionitis, NICU admission, suspected or proven neonatal sepsis, or serious neonatal complication.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton Pregnancy
  • 37.0 and 41.0 gestational age
  • Confirmed Rupture of Membranes
  • Group B Streptococcus Negative
  • Cephalic Presentation
  • Absence of contractions for at least 60 minutes following rupture
  • Absence of contractions at time of enrolment

Exclusion Criteria:

  • Contraindication to Vaginal Delivery
  • Previous Uterine Surgery, including Caesarean Section
  • Previous Cerclage, Cone Biopsy, LEEP, or Cervical Surgery
  • Documented history of cervical incompetence
  • High Grade intraepithelial lesion, adenocarcinoma in situ, or invasive cervical cancer.
  • Immunosuppressed State
  • Active Vaginal Infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890630

Locations
Canada, Ontario
St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Sponsors and Collaborators
McMaster University
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Dustin Costescu, MD, BSc McMaster University, Department of Obstetrics and Gynaecology
Principal Investigator: Amie Cullimore, MD BSc BEd McMaster University, Department of Obstetrics and Gynaecology
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Amie Cullimore, Faculty of Health Sciences, McMaster University
ClinicalTrials.gov Identifier: NCT00890630     History of Changes
Other Study ID Numbers: 09-3265
Study First Received: April 27, 2009
Last Updated: July 19, 2011
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014