Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05062343
Study type Interventional
Source Brigham and Women's Hospital
Contact Rachel L Wood, MD
Phone 617-732-8129
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date November 1, 2021
Completion date December 1, 2022

See also
  Status Clinical Trial Phase
Completed NCT03730220 - The Norwegian Induction Project: a Pilot for a Prospective National Audit
Not yet recruiting NCT05037617 - The REDUCED-I Pilot Trial: REDucing the Utilization of CEsarean Sections With Induction N/A
Completed NCT03670836 - Comparison of Misoprostol Ripening Efficacy With Dilapan Phase 4
Recruiting NCT04017247 - Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor N/A
Completed NCT02788305 - Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy N/A
Suspended NCT04004845 - Labor Protocol Study
Enrolling by invitation NCT04645823 - Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor Phase 4
Recruiting NCT04746248 - Outpatient Labor Induction Using Oral Misoprostol in Norway N/A
Completed NCT04756089 - Stimulation Therapy for Inducing Mothers N/A
Not yet recruiting NCT04307199 - Membrane Sweeping to Prevent Post-term Pregnancy: The MILO Study N/A
Recruiting NCT03725397 - Inpatient Versus Outpatient Foley Cervical Ripening Study N/A
Not yet recruiting NCT04739683 - Cervical Ripening With Foley Bulb Versus Dilapan-S at Home N/A
Completed NCT03113227 - Value of Measuring Cervical Angle and Length by Ultrasound in Prediction of Successful Induction of Delivery N/A