Amniotic Biomarkers for the Prediction of Postpartum Renal Function.

Completed

• Conditions: Nephropathy

• Registration Number: NCT02675686
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2015-07-10
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-05
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Renal function (according to Schwartz formula)	month 24	Renal function (according to Schwartz formula)

Trial Locations

Locations (30)

Hopital Saint Jacques; 🇫🇷 Besancon, France

Hopital Femme-Mere-Enfant; 🇫🇷 Bron, France

Hopital Antoine Beclere (Ap Hp); 🇫🇷 Clamart, France

Chu Estaing; 🇫🇷 Clermont Ferrand, France

Chu Grenoble; 🇫🇷 Grenoble, France

Hopital Nord; 🇫🇷 St-priest-en-jarez, France

Chu D Angers; 🇫🇷 Angers, France

Hopital Pellegrin; 🇫🇷 Bordeaux, France

Hopital Morvan; 🇫🇷 Brest, France

Ch Rene Dubos Pontoise; 🇫🇷 Cergy Pontoise, France

Hopital Du Bocage; 🇫🇷 Dijon, France

Hopital Jeanne de Flandre; 🇫🇷 Lille, France

Hopital D'Enfants de Brabois; 🇫🇷 Nancy, France

Hopital de La Timone (Ap Hm); 🇫🇷 Marseille, France

Hopital Bretonneau; 🇫🇷 Tours, France

Chu Dupuytren; 🇫🇷 Limoges, France

Hopital Arnaud de Villeneuve; 🇫🇷 Montpellier, France

Chu de Nantes; 🇫🇷 Nantes, France

Hopital Lenval; 🇫🇷 Nice, France

Centre Hospitalier CAREMEAU; 🇫🇷 Nimes, France

Hopital Robert Debre; 🇫🇷 Paris, France

Hopital Armand Trousseau (Ap-Hp); 🇫🇷 Paris, France

CHRU De POITIERS LA MILETRIE; 🇫🇷 Poitiers, France

Hopital Sud; 🇫🇷 Rennes, France

Hopital Charles Nicole; 🇫🇷 Rouen, France

Maison de Sante Protestante de Bagatelle/Bordeaux; 🇫🇷 Talence, France

Hopital Necker Enfants Malades (Ap Hp); 🇫🇷 Paris, France

Hopital Maison Blanche; 🇫🇷 Reims, France

Hopital de Hautepierre; 🇫🇷 Strasbourg, France

Chu Purpan; 🇫🇷 Toulouse, France