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Bladder emptying test may spare pregnant women invasive needles

NCT ID NCT07165743

Diagnosis Sponsor: Haseki Training and Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at whether a simple ultrasound observation of the fetal bladder emptying within 40 minutes can help rule out major chromosome issues like Down syndrome. Researchers will monitor 270 pregnant women between 11-14 weeks. If the bladder empties quickly and is very small afterward, it may be a reassuring sign, potentially reducing the need for more invasive tests.

What this could mean

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

What this could lead to
If successful, this could offer a low-risk ultrasound marker to reassure many pregnant women and reduce unnecessary invasive procedures.
What could go wrong
This is a small, single-center observational study. The marker may not be accurate enough to replace current screening, and results may not apply to all populations.

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.

Participants

About 270 people

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

Started

Aug 2025

Expected to finish

Jan 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.

Who is studied

Prospective cohort of 270 consecutive healthy pregnant women with singleton fetuses, attending first-trimester screening (11 - 14 GA) at a tertiary perinatology center in Istanbul, Türkiye.

Ages

18 to 45 years

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: * Singleton, viable pregnancy between 11 + 0 and 14 + 0 gestational weeks (GA) * Maternal age 18 - 45 years at enrollment * Able to provide written informed consent Exclusion Criteria: * Multiple gestation (twins, higher order) * Major fetal structural anomaly detected at index scan * Known serious maternal comorbidity (e.g., insulin-dependent diabetes, uncontrolled hypertension, renal or autoimmune disease) * Participation in another interventional research study during the current pregnancy

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Conditions

The condition(s) this trial relates to.

Down syndrome Trisomy 13 Syndrome Trisomy 18 Syndrome

As listed by the trial registrant

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

Chromosomal aneuploidies (E.G., trisomy 21, trisomy 18, trisomy 13); prenatal screening accuracy

Contacts and locations

Locations

  • SBÜ Haseki Training and Research Hospital - Perinatology Department

    Istanbul, Istanbul (Sultangazi District), 34265, Turkey (Türkiye)