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

Conditions

• Cervical Preparation Prior to Dilation and Evacuation

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cervical Ripening Double Balloon (CRDB) Catheter — DEVICE
  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.
• Osmotic Dilators — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Dec 3, 2025

Status verified

Feb 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cervical Ripening Double Balloon (CRDB) Catheter
• Active Comparator: Osmotic Dilators

Primary Outcome Measure

Mean Cervical Dilation [ Time Frame: Day 1 (cervical preparation visit) to Day 2 (D&E) ]

Central Contacts

• Yale Family Planning
  203-785-5074
  [email protected]

Locations (1)

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