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NCT07864142
First-Trimester Screening of Open Neural Tube Defects Using Biometrics and Maternal Serum Markers
Conditions: Neural Tube Defects (NTDs)
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: University Hospital, Strasbourg, France
Location: Service de Gynécologie et Obstétrique - CHU de Strasbourg - France Strasbourg
Summary
Open neural tube defects are congenital malformations associated with significant morbidity. Early detection during the first trimester remains a key challenge.
This retrospective monocentric study aims to evaluate the diagnostic performance of fetal biometrics (biparietal diameter and abdominal transverse diameter ratios) and maternal serum markers (beta-hCG and PAPP-A) for early screening of open neural tube defects. The study will assess the predictive value of these parameters individually and in combination to define optimal screening thresholds applicable in routine clinical practice
Eligibility Criteria
Inclusion Criteria:
* Adult pregnant woman (≥18 years)
* First-trimester ultrasound performed at Strasbourg University Hospitals between 01/01/2011 and 31/12/2023
* No written opposition to reuse of medical data for research purposes
Exclusion Criteria:
* Written opposition to reuse of medical data for research purposes
* Multiple pregnancy
* Presence of fetal growth abnormality, morphological or genetic anomaly during pregnancy
* Crown-rump length \84 mm at screening ultrasound
* Missing data
* Fetus with closed dysraphism
Source: ClinicalTrials.gov (NCT07864142). StuddyBuddy aggregates publicly available trial information.