🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.

RecruitingNAAges 18 Years - anyFemaleYale University
NCT07200115 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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 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.
💊

What it tests

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

Where

1 site
Yale Family Planning Clinic
New Haven, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy