Amniotic Biomarkers for the Prediction of Postpartum Renal Function.
NCT ID: NCT02675686
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
358 participants
OBSERVATIONAL
2010-12-31
2016-12-31
Brief Summary
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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
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
* Fetus whose mother has chronic infectious diseases (HIV, hepatitis B and C) or acute infectious diseases such chorioamnionitis.
* Parental Refusal.
ALL
Yes
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Stéphane. DECRAMER, MD; PHD
Role: PRINCIPAL_INVESTIGATOR
Néphrologie pédiatrique - Hôpital des enfants
Locations
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Hopital Nord
Amiens, , France
Chu D Angers
Angers, , France
Hopital Saint Jacques
Besançon, , France
Hopital Pellegrin
Bordeaux, , France
Hopital Morvan
Brest, , France
Hopital Femme-Mere-Enfant
Bron, , France
Ch Rene Dubos Pontoise
Cergy-Pontoise, , France
Hopital Antoine Beclere (Ap Hp)
Clamart, , France
Chu Estaing
Clermont-Ferrand, , France
Hopital Du Bocage
Dijon, , France
Chu Grenoble
Grenoble, , France
Hopital Jeanne de Flandre
Lille, , France
Chu Dupuytren
Limoges, , France
Hopital de La Timone (Ap Hm)
Marseille, , France
Hopital Arnaud de Villeneuve
Montpellier, , France
Hopital D'Enfants de Brabois
Nancy, , France
Chu de Nantes
Nantes, , France
Hopital Lenval
Nice, , France
Centre Hospitalier CAREMEAU
Nîmes, , France
Hopital Robert Debre
Paris, , France
Hopital Armand Trousseau (Ap-Hp)
Paris, , France
Hopital Necker Enfants Malades (Ap Hp)
Paris, , France
CHRU De POITIERS LA MILETRIE
Poitiers, , France
Hopital Maison Blanche
Reims, , France
Hopital Sud
Rennes, , France
Hopital Charles Nicole
Rouen, , France
Hopital Nord
Saint-Priest-en-Jarez, , France
Hopital de Hautepierre
Strasbourg, , France
Maison de Sante Protestante de Bagatelle/Bordeaux
Talence, , France
Chu Purpan
Toulouse, , France
Hopital Bretonneau
Tours, , France
Countries
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References
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Klein J, Buffin-Meyer B, Boizard F, Moussaoui N, Lescat O, Breuil B, Fedou C, Feuillet G, Casemayou A, Neau E, Hindryckx A, Decatte L, Levtchenko E, Raaijmakers A, Vayssiere C, Goua V, Lucas C, Perrotin F, Cloarec S, Benachi A, Manca-Pellissier MC, Delmas HL, Bessenay L, Le Vaillant C, Allain-Launay E, Gondry J, Boudailliez B, Simon E, Prieur F, Lavocat MP, Saliou AH, De Parscau L, Bidat L, Noel C, Floch C, Bourdat-Michel G, Favre R, Weingertner AS, Oury JF, Baudouin V, Bory JP, Pietrement C, Fiorenza M, Massardier J, Kessler S, Lounis N, Auriol FC, Marcorelles P, Collardeau-Frachon S, Zurbig P, Mischak H, Magalhaes P, Batut J, Blader P, Saulnier Blache JS, Bascands JL, Schaefer F, Decramer S, Schanstra JP; BIOMAN consortium. Amniotic fluid peptides predict postnatal kidney survival in developmental kidney disease. Kidney Int. 2021 Mar;99(3):737-749. doi: 10.1016/j.kint.2020.06.043. Epub 2020 Aug 1.
Other Identifiers
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2010-A01151-38
Identifier Type: REGISTRY
Identifier Source: secondary_id
10 138 01
Identifier Type: -
Identifier Source: org_study_id