Clinical trial NCT02344459: Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening
Official title: Randomized Controlled Trial: Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-induction Cervical Ripening
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bishop score greater than or equal to 6 at time of balloon catheter removal
timeFrame: until catheter removal (12 hours maximum)
Secondary outcomes:
measure: induction to delivery time
timeFrame: 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)
measure: vaginal delivery time less than 24 hours from initiation of induction
timeFrame: 24 hours
measure: mode of delivery
timeFrame: 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)
measure: Time to catheter expulsion
timeFrame: Up to 12 hours
measure: Type of catheter expulsion
timeFrame: 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)
measure: Epidural utilization
timeFrame: 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)
measure: Meconium stained amniotic fluid
timeFrame: 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)
measure: 5 minute Apgar score
timeFrame: The participants infant will be monitored from immediately to 5 minutes after birth
measure: Medication required to augment labor
timeFrame: 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)
measure: Artificial rupture of membranes required to augment labor
timeFrame: 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)
measure: Cesarean section indications
timeFrame: 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)
measure: Neonatal intensive care unit admissions
timeFrame: 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)
measure: Chorioamnionitis
timeFrame: 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)
measure: birthweight
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Kara K Hoppe, DO
role: PRINCIPAL_INVESTIGATOR
References: