Evaluation of Fetal Bladder Emptying During the 11-14 Weeks' Ultrasound Examination as a Negative Predictive Marker for Chromosomal Abnormalities
NCT ID: NCT07165743
Last Updated: 2025-09-10
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
270 participants
OBSERVATIONAL
2025-08-28
2026-01-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Pregnancies in which the fetal bladder empties completely within ≤ 40 minutes
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.
Pregnancies in which the bladder does not meet the rapid-emptying criteria
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Maternal age 18 - 45 years at enrollment
* Able to provide written informed consent
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Haseki Training and Research Hospital
OTHER
Responsible Party
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Can Bilginer
Fellow at Perinatology department
Locations
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SBÜ Haseki Training and Research Hospital - Perinatology Department
Istanbul, Istanbul (Sultangazi District), Turkey (Türkiye)
Countries
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References
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Capone V, Persico N, Berrettini A, Decramer S, De Marco EA, De Palma D, Familiari A, Feitz W, Herthelius M, Kazlauskas V, Liebau M, Manzoni G, Maternik M, Mosiello G, Schanstra JP, Vande Walle J, Wuhl E, Ylinen E, Zurowska A, Schaefer F, Montini G. Definition, diagnosis and management of fetal lower urinary tract obstruction: consensus of the ERKNet CAKUT-Obstructive Uropathy Work Group. Nat Rev Urol. 2022 May;19(5):295-303. doi: 10.1038/s41585-022-00563-8. Epub 2022 Feb 8.
Arasaratnam M, Balakrishnar B, Crumbaker M, Turner S, Hayden AJ, Brooks A, Patel MI, Lau H, Woo H, Bariol S, Gurney H. Patterns of care and outcomes of men with germ cell tumors in a high-volume Australian center. Asia Pac J Clin Oncol. 2022 Apr;18(2):e23-e31. doi: 10.1111/ajco.13548. Epub 2021 Jun 21.
Muller K, Kufner K, Prange K, Bengel J. [Screening for Anxiety in People with an Intellectual Disability: German Version of the "Glasgow Anxiety Scale for People with an Intellectual Disability" (GAS-ID)]. Psychiatr Prax. 2019 Jul;46(5):274-280. doi: 10.1055/a-0843-3373. Epub 2019 Mar 19. German.
Zhu R, Lv W, Sun C, Qin C, Zhang D, Long Z. A facile strategy to fabricate high-barrier, water- and oil-repellent paper with carboxymethyl cellulose/collagen fiber/modified polyvinyl alcohol. Carbohydr Polym. 2023 Aug 15;314:120933. doi: 10.1016/j.carbpol.2023.120933. Epub 2023 Apr 20.
Savarese JJ, Tabler NG Jr. Multimodal analgesia as an alternative to the risks of opioid monotherapy in surgical pain management. J Healthc Risk Manag. 2017 Jul;37(1):24-30. doi: 10.1002/jhrm.21262.
Chasserant P, Gosgnach M. Improvement of peri-operative patient management to enable outpatient colectomy. J Visc Surg. 2016 Nov;153(5):333-337. doi: 10.1016/j.jviscsurg.2016.07.006. Epub 2016 Sep 23.
Lesieur E, Barrois M, Bourdon M, Blanc J, Loeuillet L, Delteil C, Torrents J, Bretelle F, Grange G, Tsatsaris V, Anselem O. Megacystis in the first trimester of pregnancy: Prognostic factors and perinatal outcomes. PLoS One. 2021 Sep 7;16(9):e0255890. doi: 10.1371/journal.pone.0255890. eCollection 2021.
Other Identifiers
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HasekiTRH 27.08.2025 155-2025
Identifier Type: -
Identifier Source: org_study_id
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