Pre-induction Cervical Ripening
Conditions
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.
Interventions
DEVICEmechanical 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.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bishop score greater than or equal to 6 at time of balloon catheter removal | until catheter removal (12 hours maximum) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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) | — |
| 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) | — |
| 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 |
| 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) | — |
| 5 minute Apgar score | The participants infant will be monitored from immediately to 5 minutes after birth | — |
Outcome results
None listed