Cervical Ripening Double Balloon Catheters Versus Osmotic Dilators For Cervical Preparation Before Dilation & Evacuation: A Randomized Controlled Trial
Yale University
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * Spontaneous or induced fetal demise. * Multiple pregnancy. * Preterm prelabor rupture of membra…
Interventions
- DeviceCervical 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.
- DeviceOsmotic 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.
Location
- Yale Family Planning ClinicNew Haven, Connecticut