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

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborator: St. Joseph's Healthcare Hamilton
• Treatments: Oxytocin

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