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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 80mL double balloon catheter (Cook catheter®) | Experimental |
| |
| 30mL single Foley balloon catheter | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mechanical pre-induction cervical ripening | Device | The balloon catheters have been used to provide mechanical dilation to the cervix as a method of pre-induction cervical ripening. |
| Measure | Description | Time Frame |
|---|---|---|
| Bishop score greater than or equal to 6 at time of balloon catheter removal | until catheter removal (12 hours maximum) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kara K Hoppe, DO | University of Washington | Principal Investigator |
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| 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) |