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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial: Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening

Conditions
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Pre-induction Cervical Ripening

Intervention / Treatment
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* Device: mechanical pre-induction cervical ripening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 80mL double balloon catheter (Cook catheter®)<br> | Device: mechanical pre-induction cervical ripening<br>* The balloon catheters have been used to provide mechanical dilation to the cervix as a method of pre-induction cervical ripening.<br>|
| Active Comparator: 30mL single Foley balloon catheter<br> | Device: mechanical pre-induction cervical ripening<br>* The balloon catheters have been used to provide mechanical dilation to the cervix as a method of pre-induction cervical ripening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bishop score greater than or equal to 6 at time of balloon catheter removal |  | until catheter removal (12 hours maximum) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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) |