Cervical Preparation for Same-Day Dilation & Evacuation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcervical single-balloon catheter, Synthetic osmotic dilators.
- Who it may be relevant to
- Registry conditions: Abortion, Second Trimester, Procedural Pain, Procedural Complication. Basic parameters: from 16 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Same-Day Cervical Preparation Prior to Second Trimester Dilation & Evacuation: A Noninferiority Randomized Control Trial Comparing Single-Balloon Catheter and Osmotic Dilators
Overview
This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation \& Evacuation (D\&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure. The primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D\&E operative time. Secondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.
Interventions
- Device Transcervical single-balloon catheter
A single-balloon (Foley) catheter will be placed through the cervix and filled to 30cc of water or saline. The balloon will remain in the participant until their procedure, usually 3-4 hours, or earlier if it falls out on its own. - Device Synthetic osmotic dilators
Dilators will be maintained in the cervix between 3-4 hours, during which each dilator rod will swell several times its initial dried diameter.
Primary outcome measures
- Dilation & Evacuation (D&E) Operative time [Time frame: at end of procedure about 20 minutes]
Secondary outcome measures (5)
- Participant preoperative pain [Time frame: every hour until procedure, on average 3 hours]
- Participant satisfaction [Time frame: after dilation, on average 3 hours]
- Cervical dilation [Time frame: beginning of procedure, on average 3 hours]
- Number of participants with adequate cervical dilation [Time frame: beginning of procedure, on average 3 hours]
- Number of participants with surgery completed in the same day [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Between 16 weeks 0 days - 18 weeks 6 days gestational age who are pursuing termination, based on reliable gestational age (defined as ultrasonography performed by a clinical provider, or a certain last menstrual period)
- Able to provide informed consent
- English- or Spanish-speaking
- Singleton intrauterine pregnancy
Exclusion criteria
- Allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators
- Fetal demise or known fetal anomaly
- BMI >45
- Incarceration or other inability to give informed consent
- Decide to undergo cervical preparation overnight prior to next-day D\&E
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Boston Medical Center — Boston
Identifiers
NCT: NCT06799052 · H-45533