Skip to main content
OpenTrials
Completed

NCT Number: NCT02675686

Amniotic Biomarkers for the Prediction of Postpartum Renal Function.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nephropathy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Nord, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Renal function (according to Schwartz formula)

    Time frame: month 24

    Renal function (according to Schwartz formula)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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.

Acronym: BIOMAN

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Feb 5, 2016
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.