An interventional study of Transcervical single-balloon catheter and Synthetic osmotic dilators in Abortion, Second Trimester, Procedural Pain and Procedural Complication, sponsored by Boston Medical Center. Recruiting at 1 site in United States. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Boston Medical Center · Not applicable, Interventional, and Treatment
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.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 32 is below the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will have cervical dilation done using a transcervical single-balloon catheter.
Device: Transcervical single-balloon catheter
Participants randomized to this arm will have cervical dilation done using osmotic dilators.
Device: Synthetic osmotic dilators
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.
Also known as: Foley catheter
Dilators will be maintained in the cervix between 3-4 hours, during which each dilator rod will swell several times its initial dried diameter.
Also known as: Dilapan-S, seaweed laminaria
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 minutes
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 hours
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 hours
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 hours
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 hours
Number of participants with surgery completed in the same day
Abstracted from the electronic medical record, whether the surgery was completed in the same day as the dilation will be recorded as yes or no.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Dec 2026, 18 months after the start.
Of 141 non-industry interventional studies with no phase under Pain, Procedural, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 18 months is above that.
Counting every sponsor, half of 141 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
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