Association Between Pococyturia and Pre-eclampsia Severity (PEPOD2)

Prospective Study : Association Between Pococyturia and Pre-eclampsia Severity

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.

Study Overview

• Status: Recruiting
• Conditions: Pre-Eclampsia
• Intervention / Treatment: Other: Dosage of urinary podocyturia

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Muriel DORET-DION, MD; Phone Number: +33 04 27 85 51 70; Email: muriel.doret-dion@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69677
    • Terminated
    • Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France
  • Rhône
    • Pierre-Bénite, Rhône, France, 69495
      • Recruiting
      • Service de gynécologie-obstétrique
      • Contact: Muriel DORET DION, Pr; Phone Number: +33 04.78.86.33.17; Email: muriel.doret-dion@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in hospital for pre-eclampsia at the Hopital Femme-Mère-Enfant

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-eclampsia; Patients in hospital for pre-eclampsia at the Hopital Femme-Mère-Enfant	Other: Dosage of urinary podocyturia; Dosage of urinary podocyturia at admission, delivery and post-partum visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2019
• Primary Completion (Estimated): November 22, 2025
• Study Completion (Estimated): September 22, 2026

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: 69HCL17_0517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No