NCT07200115

RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.

Cervical Ripening Double Balloon Catheters Versus Osmotic Dilators For Cervical Preparation Before Dilation & Evacuation: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the overnight use of an FDA-cleared CRDB catheter is superior to the use of overnight osmotic dilators as is standard of care cervical preparation for patients presenting for dilation and evacuation (D\&E). The CRDB catheter is an FDA cleared device for cervical dilation prior to labor induction at term. It has not been FDA cleared for cervical dilation in the second-trimester, however, will be used in a similar fashion to labor inductions at term. Our standard of care osmotic dilators (e.g., laminaria, Dilapan-S) are both FDA cleared for cervical dilation prior to labor induction at term or gynecologic procedures requiring cervical dilation.

Detailed description

This study is a two-arm, non-blinded, randomized controlled trial of a cervical ripening double balloon (CRDB) catheter compared to osmotic dilators (e.g., laminaria and/or Dilapan-S) for overnight cervical preparation prior to dilation and evacuation (D\&E). The primary outcome will be mean cervical dilation as assessed by the physician immediately prior to D\&E. Established patients will be approached by a member of the research team about study participation after they have provided informed consent for D\&E. Allocation to the study group will be based on a 1:1 blocked randomization scheme. The participant will be informed of their assignment immediately prior to their cervical preparation procedure. Neither the physician nor the patient will be blinded to the assignment as this is not feasible given the differences in interventions. 1. Intervention Group: The physician will place a CRDB catheter as directed by the manufacturer's user guide. The uterine balloon of the CRDB catheter will be inflated with 20-40 mL of saline based upon the participant's tolerance. 2. Control Group: The physician will place osmotic dilators in the standard fashion. The number of dilators and use of laminaria, Dilapan-S, or a combination will be determined by physician preference. On the day of the D\&E procedure, the physician will remove the cervical dilating device and measure the patient's cervical dilation. Additional data will be collected on the following items. * Need for and amount of mechanical dilation * Total procedure time will be calculated in minutes based on the procedure start and stop times recorded in the patient's electronic medical record.

Conditions

• Cervical Preparation Prior to Dilation and Evacuation

Interventions

Type	Name	Description
DEVICE	Cervical Ripening Double Balloon (CRDB) Catheter	The physician will place a CRDB catheter for overnight cervical preparation. The CRDB catheter is comprised of two balloons that can be inflated with up to 80 mL of sterile water.
DEVICE	Osmotic Dilators	Osmotic dilators (e.g., laminaria and Dilapan-S) are mechanical dilators that are placed in the cervix prior to gynecologic procedures and facilitate dilation through the slow absorption of moisture. The physician will place osmotic dilators in the standard fashion.

Timeline

• Start date: 2025-12-03
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2025-09-30
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study