NCT05062343

Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Induced; Birth

Interventions

Type	Name	Description
DEVICE	Dilapan-S	Osmotic dilator
DEVICE	Cook Cervical Ripening Balloon	Double balloon catheter for cervical ripening

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-07-19
• Completion: 2023-07-19
• First posted: 2021-09-30
• Last updated: 2023-10-27
• Results posted: 2023-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study