Condition: Cervical Preparation Prior to Dilation and Evacuation · Sponsor: Yale University
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 description comes directly from the study's public registry record.
Yale Family Planning · 203-785-5074 · fpresearch@yale.edu
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| Yale Family Planning Clinic | New Haven, Connecticut, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07200115