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

Fetal Membranes, Premature Rupture Clinical Trial

— IC-PROM  

Official title:

Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term: A Pilot Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00890630
• Other study ID #: 09-3265
• Status: Terminated
• Phase: Phase 2
• First received: April 27, 2009
• Last updated: July 19, 2011
• Start date: April 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Induced Labor
• Rupture

Intervention

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.

Locations

Country	Name	City	State
Canada	St Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility		48 hours	No
Secondary	Intrapartum Fever		48 Hours	Yes
Secondary	Duration of Labour		48 hours	No
Secondary	NICU Admission		0-7 days postpartum	Yes
Secondary	Chorioamnionitis		48 Hours	Yes
Secondary	Patient Satisfaction		0-6 weeks Postpartum	No