Status:
TERMINATED
Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term
Lead Sponsor:
McMaster University
Collaborating Sponsors:
St. Joseph's Healthcare Hamilton
Conditions:
Fetal Membranes, Premature Rupture
Induced Labor
Eligibility:
FEMALE
Phase:
PHASE2
Brief 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...
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 o...
Eligibility Criteria
Inclusion
- Singleton Pregnancy
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00890630
Start Date
April 1 2010
End Date
July 1 2011
Last Update
July 20 2011
Active Locations (1)
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1
St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada