Amniotic Biomarkers for the Prediction of Postpartum Renal Function.

Amniotic Fluid Biomarker Research for Prediction of Postnatal Renal Function in Fetus With a Bilateral Abnormal Renal Development: National, Multicenter, Prospective and Non-interventional Study.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02675686

Acronym

BIOMAN

Enrollment

358

Registered

2016-02-05

Start date

2010-12-31

Completion date

2016-12-31

Last updated

2024-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephropathy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Renal function (according to Schwartz formula)	month 24	Renal function (according to Schwartz formula)

Countries

France

Outcome results