Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves (Antenatal)

Toulouse University Hospital

Status: Enrolling

Conditions: Posterior Urethral Valves

Study type: Observational

Funder types: Other

Identifiers

NCT03116217

16/8805

2016-A01914-47 (Other Identifier)

Details and patient eligibility

About

Validate the use of fetal urine peptidome-analysis and explore amniotic fluid markers for the stratification of fetuses with Posterior Urethral Valve for post-natal renal function.

Full description

The ANTENATAL project requires the use of fetal urine as well as post-natal urine, post-natal serum and, possibly, amniotic liquid. We will take an additional tube during the takings collected for routine management of the disease.

The analysis of samples will be carried out in Toulouse at the Institute of Metabolic and Cardiovascular Diseases or with fee-for-service suppliers.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male singleton fetus with megabladder associated with urinary tract anomalies with or without dysplastic or hyperechogenic parenchyma detected in a first ultrasound;
• megabladder confirmed in a second ultrasound;
• collection of fetal urine taken during the routine management of the disease for the dosage of ß2-microglobulin;
• written informed consent.

Exclusion criteria

• refusal to participate in the study;
• person protected by law.