ACTIVE NOT RECRUITING
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.
Gender: FEMALE
Ages: 18 Years - 45 Years
Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening Accuracy
