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

Overview

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.

Full Title of Study: “Randomized Controlled Trial: Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2013

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 80mL double balloon catheter (Cook catheter®)
  • Active Comparator: 30mL single Foley balloon catheter

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • induction to delivery time
    • Time Frame: 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
    • Time Frame: 24 hours
  • mode of delivery
    • Time Frame: 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
    • Time Frame: Up to 12 hours
  • Type of catheter expulsion
    • Time Frame: 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)
    • spontaneous vs. provider
  • Epidural utilization
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: The participants infant will be monitored from immediately to 5 minutes after birth
  • Medication required to augment labor
    • Time Frame: 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)
    • prostaglandins, oxytocin
  • Artificial rupture of membranes required to augment labor
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kara Hoppe, Maternal Fetal Medicine Fellow – University of Washington
  • Overall Official(s)
    • Kara K Hoppe, DO, Principal Investigator, University of Washington

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