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New treatment option for Cervical Preparation Prior to Dilation and Evacuation
Official title RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.
ClinicalTrials.gov ID: NCT07200115
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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.
You likely can't join if
- Spontaneous or induced fetal demise.
- Multiple pregnancy.
- Preterm prelabor rupture of membranes (PPROM).
- Intraamniotic infection.
- Active genital tract infection.
- Active vaginal bleeding.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.