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.
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.
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)
Single group
Amniotic Fluid Proteomic Analysis Using Capillary Electrophoresis-Mass Spectrometry (CE-MS)
Other interventionThis 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
Sensitivity and specificity of the test in the evaluation of renal survival (need for dialysis) and patient survival at 2 years of life.
Renal survival is defined as the absence of end-stage renal disease (ESRD) requiring dialysis by 2 years of age. Patient survival is defined as the child being alive at 2 years. Renal function is assessed through clinical follow-up, including serum creatinine measurements and estimated glomerular filtration rate (eGFR) using the Schwartz formula. Dialysis initiation is determined based on standard clinical criteria for ESRD. Survival status is confirmed through medical records and follow-up visits. This outcome aims to validate the predictive value of the 98-peptide amniotic fluid signature for postnatal kidney function in CAKUT fetuses.
Sensitivity and specificity of the test in the evaluation of postnatal renal function estimated by the Schwartz formula and his serum creatinine
Schwartz formula which is based on the patient's height (T, in cm) and his serum creatinine (Creat, in µmol/L) (T\*36.5/Creat)
Severity score result rendering time
measure of the delay to give the result to the investigator site
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