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NCT03316430 Clinical Trial

Podocyturia as Predictive Factor for Pre-eclampsia

Pre-Eclampsia Clinical Trial

— PEPOD1  

Official title:
Prospective Study : Podocyturia as Predictive Factor for Pre-eclampsia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03316430
Other study ID # 69HCL17_0516
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2019
Est. completion date December 7, 2021

Study information
Verified date January 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Podocyn could be identified in the urine, before proteinuria, a key element in the diagnostic of pre-eclampsia. Preventive treatment using aspirin could be administrated in early pregnancy. We hypothesized that podocyturia could be an early indicator of preeclampsia. This is a prospective, non-interventional, monocentric study.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date December 7, 2021
Est. primary completion date December 7, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - women aged 18 years or more - single pregnancy - first planned prenatal visit before 16 weeks of gestation - planned delivery at Hôpital Femme Mère Enfant in Lyon, France - patient receiving information and non opposition to participate Exclusion Criteria: - multiple pregnancy - pregnancy stopped - antecedent of nephropathy - inability to understand information provided - prisoner or under administrative supervision - fetal malformation, chromosomal anomalies - preterm delivery for other reason that any hypertensive disorder of pregnancy or Intrauterine growth restriction

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Podocyturia quantification
Podocyturia quantification at first planned prenatal care visit before 16 weeks of gestation

Locations
Country Name City State
France Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of pre-eclampsia Occurrence of pre-eclampsia during pregnancy At childbirth (around 8 months)
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