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Balloon or dilators? new study seeks better way to prepare for abortion procedure

NCT ID NCT07200115

Symptom relief Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two FDA-cleared devices used to soften and open the cervix before a dilation and evacuation (D&E) procedure in the second trimester. One device is a balloon catheter, the other is a set of absorbent rods (osmotic dilators). The goal is to see which method works better and makes the procedure faster and easier. About 50 pregnant people between 19 and 23 weeks will take part.

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 50 people

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

Started

Dec 2025

Expected to finish

Sep 2028

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

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Dilatation, Pathologic

As listed by the trial registrant

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

Cervical preparation prior to dilation and evacuation

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Yale Family Planning Clinic

    RECRUITING

    New Haven, Connecticut, 06519, United States

    Contact Email: •••••@•••••