Status:
ACTIVE_NOT_RECRUITING
Evaluation of Fetal Bladder Emptying During the 11-14 Weeks' Ultrasound Examination as a Negative Predictive Marker for Chromosomal Abnormalities
Lead Sponsor:
Haseki Training and Research Hospital
Conditions:
Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening Accuracy
Eligibility:
FEMALE
18-45 years
Brief 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 Ch...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT07165743
Start Date
August 28 2025
End Date
January 30 2026
Last Update
September 10 2025
Active Locations (1)
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1
SBÜ Haseki Training and Research Hospital - Perinatology Department
Istanbul, Istanbul (Sultangazi District), Turkey (Türkiye), 34265