Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening

Randomized Controlled Trial: Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening

The purpose of this study is to perform a randomized controlled trial to compare the efficacy of 80mL double balloon catheter versus a 30mL single catheter balloon for pre-induction cervical ripening by evaluating the change in Bishop score.

Study Overview

• Status: Completed
• Conditions: Pre-induction Cervical Ripening
• Intervention / Treatment: Device: mechanical pre-induction cervical ripening

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Bishop score of 5 or less
• Singleton
• Cephalic presentation
• Fewer than 4 contractions in 10 minutes
• Reactive fetal monitoring

Exclusion Criteria:

• Non-vertex presentation
• Placenta previa
• Vasa previa
• Unexplained vaginal bleeding
• Active herpes simplex virus infection
• Non-English speaking
• Previous attempt at an induction of labor in the current pregnancy
• Prolapsed umbilical cord
• More than one prior cesarean delivery or history of classical cesarean delivery
• Patients receiving or planning to undergo exogenous prostaglandin administration as the primary induction agent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 80mL double balloon catheter (Cook catheter®)	Device: mechanical pre-induction cervical ripening; The balloon catheters have been used to provide mechanical dilation to the cervix as a method of pre-induction cervical ripening.
Active Comparator: 30mL single Foley balloon catheter	Device: mechanical pre-induction cervical ripening; The balloon catheters have been used to provide mechanical dilation to the cervix as a method of pre-induction cervical ripening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bishop score greater than or equal to 6 at time of balloon catheter removal	until catheter removal (12 hours maximum)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
induction to delivery time		The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
vaginal delivery time less than 24 hours from initiation of induction		24 hours
mode of delivery		The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Time to catheter expulsion		Up to 12 hours
Type of catheter expulsion	spontaneous vs. provider	The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Epidural utilization		The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Meconium stained amniotic fluid		The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
5 minute Apgar score		The participants infant will be monitored from immediately to 5 minutes after birth
Medication required to augment labor	prostaglandins, oxytocin	The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Artificial rupture of membranes required to augment labor		The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Cesarean section indications		The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Neonatal intensive care unit admissions		The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Chorioamnionitis		The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
birthweight		The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Kara K Hoppe, DO, University of Washington

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: January 16, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Estimate): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 16, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 36685-D