Cervical Ripening Double Balloon Catheter for Cervical Ripening

(CRDB RCT Trial)

Overseen By Yale Family Planning

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Multiple pregnancy, Infection, Bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Tessa Madden, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for patients needing cervical preparation before a dilation and evacuation (D&E) procedure. Participants should require the procedure, be willing to stay overnight in the hospital, and have no contraindications to using CRDB catheters or osmotic dilators.

Inclusion Criteria

Residents of the state of Connecticut

I speak English or Spanish.

I am pregnant with one baby, between 19 to 24 weeks along.

Exclusion Criteria

Placenta accreta spectrum

Spontaneous or induced fetal demise

Multiple pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Cervical Preparation

Participants undergo cervical preparation using either a CRDB catheter or osmotic dilators overnight

1 day

1 visit (in-person)

Dilation and Evacuation (D&E)

The cervical dilating device is removed, and the D&E procedure is performed

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the D&E procedure

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cervical Ripening Double Balloon (CRDB) Catheter
• Osmotic Dilators

Trial Overview The study compares two methods of preparing the cervix for D&E: an FDA-cleared Cervical Ripening Double Balloon (CRDB) Catheter versus standard overnight osmotic dilators. The goal is to see if CRDB is superior for this purpose.

How Is the Trial Designed?

Group I: Cervical Ripening Double Balloon (CRDB) Catheter Experimental Treatment 1 Intervention

Group II: Osmotic Dilators Active Control 1 Intervention

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+