Cervical Preparation for Same-Day Dilation & Evacuation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16+
SponsorBoston Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Transcervical single-balloon catheter
DeviceA 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.
Synthetic osmotic dilators
DeviceDilators will be maintained in the cervix between 3-4 hours, during which each dilator rod will swell several times its initial dried diameter.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Transcervical single-balloon catheter groupExperimental treatment 1 intervention
Group B: Osmotic dilators groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dilation & Evacuation (D&E) Operative time
the total duration in D\&E operative time measured in minutes. Operative start time will be marked as the time that the speculum is inserted for the first time. Operative end time will be marked as the time that the speculum is removed at the end of the case.
Time frame
at end of procedure about 20 minutesSecondary outcomes
1
Participant preoperative pain
Participant pain will be assessed via a 100 point visual analog scale immediately post-cervical preparation and at every hour interval until their D\&E. Higher scores are associated with more pain.
Time frame
every hour until procedure, on average 3 hours2
Participant satisfaction
Participant satisfaction will be assessed with a 5-point Likert scale from very dissatisfied to very satisfied.
Time frame
after dilation, on average 3 hours3
Cervical dilation
Cervical dilation will be measured in millimeters at the beginning of the procedure by the surgeon.
Time frame
beginning of procedure, on average 3 hours4
Number of participants with adequate cervical dilation
Abstracted from the operative record, dilation will be considered adequate if no manual dilation is needed.
Time frame
beginning of procedure, on average 3 hoursSponsors and contacts
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Source ClinicalTrials.gov