Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening
Not Applicable
Completed
- Conditions
- Pre-induction Cervical Ripening
- Interventions
- Device: mechanical pre-induction cervical ripening
- Registration Number
- NCT02344459
- Lead Sponsor
- University of Washington
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 105
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 30mL single Foley balloon catheter mechanical pre-induction cervical ripening - 80mL double balloon catheter (Cook catheter®) mechanical pre-induction cervical ripening -
- Primary Outcome Measures
Name Time Method Bishop score greater than or equal to 6 at time of balloon catheter removal until catheter removal (12 hours maximum)
- Secondary Outcome Measures
Name Time Method 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) 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) 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) 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) 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) 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) 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) Time to catheter expulsion Up to 12 hours Type of catheter expulsion 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
5 minute Apgar score The participants infant will be monitored from immediately to 5 minutes after birth Medication 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) prostaglandins, oxytocin
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) 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)