Amniotic Biomarkers for the Prediction of Postpartum Renal Function. (BIOMAN)

Toulouse University Hospital

Status: Completed

Conditions: Nephropathy

Study type: Observational

Funder types: Other

Identifiers

NCT02675686

2010-A01151-38 (Registry Identifier)

10 138 01

Details and patient eligibility

About

The discovery of antenatal bilateral renal anomaly poses an essential question: can we predict postnatal renal function? Ultrasound is insufficiently precise to predict postnatal renal function evolution.

The objective of this study is to estimate the specificity and sensitivity of amniotic fluid biomarkers to predict postnatal renal function in fetuses with bilateral developmental nephropathies.

Both fetuses with bilateral renal anomalies and control (healthy) fetuses will be included.

For this study amniotic fluid will only be collected according to routine clinical practice and only excess amniotic fluid sample will be used for the study.

The potentially identified biomarkers will not change routine management of the pregnancies in the study.

Enrollment: 358 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All fetuses with a bilateral abnormal renal development (structure modification of the parenchyma with or without urinary tract abnormalities associated)

The following sonographic criteria are used:

• Fetal kidney size <2.5ep or <2 standard deviation (SD) defining renal hypoplasia or renal size> 97.5ep or> 2 SD defining nephromegaly
• And / or hyperechogenicity (more echogenic than the liver kidney)
• And / or cysts
• And / or abnormal cortico-medullary differentiation (decrease or lack thereof)
• And / or bilateral cortical thinning
• And / or the possibility of an initial unilateral renal disease in the case of a pathology on which kidney damage is usually to become bilateral during evolution

Exclusion criteria

• Foetuses with severe malformations that can change the amniotic or urine proteome: complex heart disease, digestive stenosis, fetal immobility.
• Fetus whose mother has chronic infectious diseases (HIV, hepatitis B and C) or acute infectious diseases such chorioamnionitis.
• Parental Refusal.