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Balloon catheter vs. dilators: which works better for Same-Day cervical prep?

NCT ID NCT06799052

Disease control Sponsor: Boston Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study compares two ways to soften and open the cervix before a second-trimester abortion procedure called dilation and evacuation (D&E). One method uses a small balloon catheter placed through the cervix for a few hours; the other uses synthetic rods that swell as they absorb moisture. The goal is to see if the balloon method works as well as the dilators, focusing on how long the procedure takes, pain, and satisfaction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcervical single-balloon catheter (Foley catheter) and synthetic osmotic dilators (Dilapan-S)
What this could lead to
If the balloon catheter works as well as osmotic dilators, it could offer a simpler, more comfortable option for cervical preparation before a second-trimester abortion.
What could go wrong
This is a small, early-stage trial with only 32 participants, so results may not apply to everyone. The balloon method might not prepare the cervix as effectively, leading to longer or more complicated procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Pain, Procedural Patient Satisfaction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abortion, second trimester Procedural complication Procedural pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

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