An interventional study of Cervical Ripening Double Balloon (CRDB) Catheter and Osmotic Dilators in Cervical Preparation Prior to Dilation and Evacuation, sponsored by Yale University. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
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.
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.
120 studies on the registry are indexed under Dilatation, Pathologic; 18 are open to participants now.
This study's planned enrollment of 50 is below the median of 82 across 84 interventional studies indexed under Dilatation, Pathologic.
Browse Dilatation, Pathologic studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Cervical Ripening Double Balloon (CRDB) Catheter
Device: Osmotic Dilators
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 (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.
Mean Cervical Dilation
Cervical dilation will be measured in centimeters.
Time frame: Day 1 (cervical preparation visit) to Day 2 (D&E)
Need for Mechanical Dilation at the Time of Procedural Abortion
This is a binary "yes/no" outcome reported as the percentage of patients needing mechanical dilation in our experimental arm compared to the active comparator arm.
Time frame: Day 2 (D&E)
Mean Total Procedure Time
Procedure time will be measured in minutes.
Time frame: Day 2 (D&E)
Plan to share: No
Started Dec 2025 (actual). Primary completion is estimated for Sep 2027, 21 months after the start.
Of 27 interventional studies with no phase under Dilatation, Pathologic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 21 months is below that.
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