MedTrace Logo

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

NCT07165743 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 270

Last updated 2025-09-10

No results posted yet for this study

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.

Conditions

  • Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening Accuracy

Interventions

DIAGNOSTIC_TEST

40-Minute Real-Time First-Trimester Ultrasonography

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.

Sponsors & Collaborators

  • Haseki Training and Research Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-28
Primary Completion
2025-10-31
Completion
2026-01-30

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07165743 on ClinicalTrials.gov