Association Between Pococyturia and Pre-eclampsia Severity

Recruiting

• Conditions: Pre-Eclampsia
• Interventions: Other: Dosage of urinary podocyturia

• Registration Number: NCT03316391
• 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. Twenty four hours proteinuria is a key element to define pre-eclampsia severity but is delaying the result by 24 hours and constraining for the patient. A simple and rapid indicator for severe preeclampsia would help clinicians to make appropriate decision in patient management. We hypothesized that urinary podocyturia is correlated to preeclampsia severity. 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: 2019-05-22
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-11-22
• Study Completion: 2026-09-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• women aged 18 years or more
• single pregnancy
• admission for pre-eclampsia
• patient receiving information and non-opposition to participate

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Exclusion Criteria

• multiple pregnancy
• in utero fetal demise excepted if associated with pre-eclampsia
• antecedent of nephropathy
• fetal malformation, chromosomal anomalies
• inability to understand information provided
• prisoner or under administrative supervision

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-eclampsia	Dosage of urinary podocyturia	Patients in hospital for pre-eclampsia at the Hopital Femme-Mère-Enfant

Primary Outcome Measures

Name	Time	Method
Severity of pre-eclampsia	at childbirth (maximum 10 months)	Severe preeclampsia is defined by preeclampsia with at least one of the following criteria : * severe hypertension (PAS ≥ 160 mmHg et/ou PAD ≥ 110 mmHg); * Renal impairment with: oliguria \<500 ml / 24h or creatinine\> 135 μmol / L or proteinuria\> 5 g/d; * acute lung edema or persistent epigastric bar or HELLP syndrome; * eclampsia or rebellious neurological disorders (visual disturbances, polykinetic ROT, headache),; * thrombocytopenia \<100 G / L; * Retro Placental Hematoma (HRP) or fetal repercussion.

Trial Locations

Locations (2)

Service de gynécologie-obstétrique; 🇫🇷 Pierre-Bénite, Rhône, France

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