Proteomic Analysis of Amniotic Fluid to Predict Postnatal Renal Function in Fetuses With Renal and Urinary Tract Malformations
University Hospital, Toulouse
78 participants
Jul 18, 2025
INTERVENTIONAL
Conditions
Summary
The aim of this project is to validate a previously established amniotic fluid 98 peptide signature predictive of post-natal outcome in fetuses with congenital anomalies of the kidney and the urinary tract (CAKUT) in a "real" clinical context. It includes the feasibility of collecting, transporting and analyzing the amniotic fluid peptidome from clinical centers all over France and of providing the result in a clinically accepted time-frame. Therefore, this multicenter study will not only allow to determine the added value of such new prenatal test but also to ensure the feasibility of its introduction in the management of CAKUT pregnancies.
Eligibility
Inclusion Criteria3
- All fetuses with bilateral renal development anomalies with structural changes in the parenchyma, with or without associated urinary tract anomalies;
- Signed informed consent of the mother
- Non-opposition of the father.
Exclusion Criteria4
- Unilateral abnormality of renal development
- Any pregnancy for which amniocentesis may represent a risk for the fetus or the mother
- Twin pregnancies
- Pregnant woman protected by law (guardianship, curatorship)
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Interventions
This intervention consists of analyzing the amniotic fluid proteome using capillary electrophoresis coupled with mass spectrometry (CE-MS). The goal is to evaluate a predefined 98-peptide signature that predicts postnatal kidney function in fetuses with bilateral congenital anomalies of the kidney and urinary tract. Unlike standard prenatal assessments based on ultrasound and fetal biochemistry, this method provides a molecular-based prognostic tool to improve decision-making regarding pregnancy management and neonatal care
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06912490