Active — Not RecruitingNot Applicable

Evaluation of Fetal Bladder Emptying During the 11-14 Weeks' Ultrasound Examination as a Negative Predictive Marker for Chromosomal Abnormalities

Turkey (Türkiye)270 participantsStarted 2025-08-28

Plain-language summary

Template-Based Brief Summary (Sağlık Profesyonelleri İçin) Study Title: The Negative Predictive Value of First-Trimester Fetal Bladder "Rapid Emptying" (≤40 minutes and post-void ≤2 mm) for Major Chromosomal Aneuploidies: A Prospective Diagnostic Accuracy Study. Purpose: To evaluate whether the dynamic phenotype of rapid bladder emptying at 11-14 weeks reduces the likelihood of major chromosomal abnormalities (particularly Trisomy 21) compared to fetuses without this phenotype. Design: Single-center, prospective observational cohort. Population: 270 singleton pregnancies between 11+0 and 14+0 weeks. Procedures: Real-time sagittal ultrasound observation for 40 minutes. Documentation of bladder emptying time and post-void longitudinal bladder diameter. Concurrent measurement of CRL, NT, ductus venosus waveform. Gold standard confirmation with cfDNA or invasive karyotyping in high-risk cases. Primary Endpoint: Negative predictive value (NPV), ROC-AUC, sensitivity/specificity for aneuploidy detection. Secondary Endpoints: Rate of invasive testing, performance in combined models with cfDNA and biophysical markers, Net Reclassification Index. Duration: 5 months (08/2025 - 01/2026). Potential Impact: If validated, the rapid emptying phenotype may serve as a low-risk marker, reduce unnecessary invasive procedures, and refine first-trimester screening algorithms.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Negative Predictive Value (NPV) of Rapid Fetal Bladder Emptying for Detecting Major Chromosomal Aneuploidy

Timeframe: From enrollment at 11 + 0 to 14 + 0 gestational weeks until definitive genetic result or delivery, whichever comes first (≈ 26 weeks).

Trial details

NCT IDNCT07165743

SponsorHaseki Training and Research Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-31

View on ClinicalTrials.gov More Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening Accuracy trials