Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening

Study Overview
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Brief Summary
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The goal of this study is to compare Cook balloon and Dilapan-S for outpatient cervical ripening to see if Dilapan-S is non-inferior in increasing Bishop score compared to the Cook balloon.

Detailed Description
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Upon presentation for cervical ripening appointment, a sterile vaginal exam will be completed to assign Bishop score, as per standard routine. Once the patient has been consented and randomized, the participant will have a Cook catheter or Dilapan-S inserted. For the Cook catheter, the uterine component of the balloon will be inflated to maximum 60mL, the vaginal balloon will not be inflated per standard practice and per the literature that shows slightly increased pain and negligible improvement in cervical ripening. The catheter will be taped to the inner thigh with gentle traction. For Dilapan-S, 3-5 dilators will be placed. After placement, the patient will be discharged home with strict return precautions per the outpatient cervical ripening protocol. Patients must return to labor and delivery within 24 hours of cervical ripening agent placement at their scheduled inpatient induction time. Upon return to labor and delivery, if not already expelled, the mechanical ripening device will be removed, and an examiner blinded to the cervical ripening method will complete a sterile vaginal exam to assign a Bishop score. At that point health care providers will manage active labor per usual practice. Labor interventions are at the discretion of the healthcare provider. The need for operative delivery or cesarean section will be at the discretion of the healthcare provider.

Official Title
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Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening

Conditions
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Induced; Birth

Intervention / Treatment
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* Device: Dilapan-S
* Device: Cook Cervical Ripening Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-50 years of age Term (37-41 6/7 weeks gestational age) Low risk (i.e. without any maternal or fetal co-morbidity) and who are candidates for outpatient cervical ripening per the Brigham and Women's outpatient cervical ripening protocol Singleton pregnancy Cephalic presentation Exclusion Criteria: Prior cesarean section Any contraindication to outpatient cervical ripening per Brigham and Women's outpatient cervical ripening protocol Non-English-speaking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Randomized Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dilapan-S<br>After randomization, the patient will have Dilapan-S placed via sterile speculum exam with placement of 3-5 rods. The rods will remain in place until expelled or up to 24 hours or until the scheduled return to labor and delivery. At presentation to labor and delivery, the rods will be confirmed expelled or will be removed and a blinded examiner will complete a sterile cervical exam. At that point the primary health care providers will manage further labor per their standard practice. | Device: Dilapan-S<br>* Osmotic dilator<br>|
| Active Comparator: Cook Catheter<br>After randomization, the patient will have the Cook catheter placed via sterile vaginal or speculum exam with the uterine component of the balloon inflated to maximum 60mL. The balloon will remain in place until expelled or up to 24 hours or until the scheduled return to labor and delivery. At presentation to labor and delivery, the Cook catheter will be confirmed expelled or will be removed and a blinded examiner will complete a sterile cervical exam. At that point the primary health care providers will manage further labor per their standard practice. | Device: Cook Cervical Ripening Balloon<br>* Double balloon catheter for cervical ripening<br>* Other names: Cook catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bishop Score | Difference in Bishop score calculated from exam at time of device removal minus Bishop score calculated from exam at time of device placement. Bishop score, or cervical score, ranges from a minimum of 0 to maximum of 13. Higher scores indicate that the cervix is more favorable, or ready for labor. Thus, change in Bishop score could range from -13 to +13 with a higher number showing more change in the score, or more cervical ripening. | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Patient Satisfaction score based on patient survey. Range from 0 (unsatisfied) to 10 (highly satisfied). | Assessed upon device removal, within 24 hours | 
| Mode of Delivery: Vaginal Delivery, Cesarean Delivery | Mode of delivery, vaginal (including spontaneous vaginal, forceps and vacuum) and cesarean delivery | Assessed at the time of delivery, within 1 week | 
| Time on Labor and Delivery | Time from admission on labor and delivery until delivery. Measured in hours. | Assessed at the time of delivery, within 1 week | 
| Maternal Length of Stay | Admission Date/Time to Discharge Date/Time | Assessed at end of study period (week 4) | 
| Cervical Ripening Success Score: No Failure, Failure | Failure defined by: inability to place intervention agent or need for further cervical ripening after removal | Assessed at the time of device removal, within 24 hours | 
| Composite Maternal Morbidity: Morbidity, no Morbidity | Morbidity defined as any one of the following: higher-order laceration, blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission or death | Assessed at end of study period (week 4) | 
| Composite Neonatal Morbidity: Morbidity, no Morbidity | Morbidity defined as any one of the following: culture-proven neonatal sepsis, neonatal blood transfusion, hypoxic-ischemic encephalopathy, intraventricular hemorrhage grade 3 or 4, or therapeutic hypothermia | Assessed at end of study period (week 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induction of labor, Cervical ripening