Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term
NCT ID: NCT00890630
Last Updated: 2011-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
5 participants
INTERVENTIONAL
2010-04-30
2011-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Oxytocin
Induction of Labour with Oxytocin Alone
Oxytocin
IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min.
Intracervical Catheter
Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction.
Intracervical Balloon Catheter
Intracervical insertion of an 80cc Double-Balloon Catheter.
Oxytocin
IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min.
Interventions
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Intracervical Balloon Catheter
Intracervical insertion of an 80cc Double-Balloon Catheter.
Oxytocin
IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
FEMALE
No
Sponsors
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St. Joseph's Healthcare Hamilton
OTHER
McMaster University
OTHER
Responsible Party
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Faculty of Health Sciences, McMaster University
Principal Investigators
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Dustin Costescu, MD, BSc
Role: PRINCIPAL_INVESTIGATOR
McMaster University, Department of Obstetrics and Gynaecology
Amie Cullimore, MD BSc BEd
Role: PRINCIPAL_INVESTIGATOR
McMaster University, Department of Obstetrics and Gynaecology
Locations
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St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Countries
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References
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de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
Costescu DJ, Cullimore AJ. Lessons learned from a resident-led clinical trial in obstetrics. Clin Trials. 2013 Aug;10(4):612-6. doi: 10.1177/1740774513492045. Epub 2013 Jun 13.
Other Identifiers
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09-3265
Identifier Type: -
Identifier Source: org_study_id
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