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
Yale University
50 participants
Dec 3, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Singleton pregnancy between 19 weeks 0 days to 23 weeks 6 days GD.
- Planning to undergo D\&E with Yale Family Planning and has undergone standard informed clinical consent counseling for the procedure and signed the clinical procedure consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the active part of the study.
- English- or Spanish-speaking individual.
- Residents of the state of Connecticut.
Exclusion Criteria12
- Spontaneous or induced fetal demise.
- Multiple pregnancy.
- Preterm prelabor rupture of membranes (PPROM).
- Intraamniotic infection.
- Active genital tract infection.
- Active vaginal bleeding.
- Placenta previa or vasa previa.
- Placenta accreta spectrum.
- History of \>3 cesarean deliveries.
- BMI \>45 kg/m2.
- Contraindication to osmotic cervical dilator or CRDB catheter use as determined by the physician.
- Contraindication to medication used during standard of care cervical preparation.
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Interventions
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.
Locations(1)
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NCT07200115