Clinical trial NCT00890630: Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term
Official title: Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Fetal Membranes, Premature Rupture
Induced Labor
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
First posted: 2009-04-30
Enrollment: 5
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 of membranes at term.

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 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

Primary outcomes:
measure: Feasibility
timeFrame: 48 hours
Secondary outcomes:
measure: Intrapartum Fever
timeFrame: 48 Hours
measure: Duration of Labour
timeFrame: 48 hours
measure: NICU Admission
timeFrame: 0-7 days postpartum
measure: Chorioamnionitis
timeFrame: 48 Hours
measure: Patient Satisfaction
timeFrame: 0-6 weeks Postpartum
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University, Department of Obstetrics and Gynaecology
name: Dustin Costescu, MD, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University, Department of Obstetrics and Gynaecology
name: Amie Cullimore, MD BSc BEd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.