Association Between Pococyturia and Pre-eclampsia Severity

Pre-Eclampsia Clinical Trial

— PEPOD2  

Official title:

Prospective Study : Association Between Pococyturia and Pre-eclampsia Severity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03316391
• Other study ID #: 69HCL17_0517
• Status: Recruiting
• Start date: May 22, 2019
• Est. completion date: September 22, 2026

Study information

• Verified date: March 2024
• Source: Hospices Civils de Lyon
• Contact: Muriel DORET-DION, MD
• Phone: 04 27 85 51 70
• Email: muriel.doret-dion[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 22, 2026
• Est. primary completion date: November 22, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• women aged 18 years or more

• single pregnancy

• admission for pre-eclampsia

• patient receiving information and non-opposition to participate

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Other:
• Dosage of urinary podocyturia
Dosage of urinary podocyturia at admission, delivery and post-partum visit

Locations

Country	Name	City	State
France	Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France	Bron
France	Service de gynécologie-obstétrique	Pierre-Bénite	Rhône

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	Severity of pre-eclampsia	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.	at childbirth (maximum 10 months)