Podocyturia as Predictive Factor for Pre-eclampsia

Completed

• Conditions: Pre-Eclampsia
• Interventions: Other: Podocyturia quantification

• Registration Number: NCT03316430
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-20
• Study Start: 2019-05-15
• Primary Completion: 2021-12-07
• Study Completion: 2021-12-07
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1000

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Podocyturia quantification	Patients coming before 16 weeks of gestation at their first planned prenatal visit at the Hôpital Femme Mère Enfant, who planned to deliver at the Hôpital Femme Mère Enfant

Primary Outcome Measures

Name	Time	Method
Occurrence of pre-eclampsia	At childbirth (around 8 months)	Occurrence of pre-eclampsia during pregnancy

Trial Locations

Locations (1)

Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France; 🇫🇷 Bron, France