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NCT Number: NCT07165743

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening Accuracy Abnormalities, Multiple Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Trisomy 13 Syndrome Trisomy 18 Syndrome

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

SBÜ Haseki Training and Research Hospital - Perinatology Department

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

40-Minute Real-Time First-Trimester Ultrasonography

Diagnostic Test

A one-time midsagittal ultrasound performed between 11 +0 and 14 +0 weeks. Bladder emptying time and post-void longitudinal bladder diameter are recorded. No invasive procedures are performed.

Primary outcomes

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

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

Proportion of fetuses with the rapid-emptying phenotype (≤ 40-minute complete emptying + post-void longitudinal bladder diameter ≤ 2 mm) who are subsequently confirmed not to have a major chromosomal aneuploidy (Trisomy 21, 18, or 13) by cfDNA, invasive karyotype, or postnatal testing.

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

Negative Predictive Value of Rapid Emptying of the Fetal Bladder (≤40 Min and Post-void ≤2 mm) on Major Chromosome Aneuploidies at 11-14 Gestational Weeks: A Prospective Diagnostic Accuracy Study

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Sep 10, 2025
Registry last updated: Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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