Podocyturia as Predictive Factor for Pre-eclampsia (PEPOD1)

Prospective Study : Podocyturia as Predictive Factor for Pre-eclampsia

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.

Study Overview

• Status: Completed
• Conditions: Pre-Eclampsia
• Intervention / Treatment: Other: Podocyturia quantification

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; 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	Other: Podocyturia quantification; Podocyturia quantification at first planned prenatal care visit before 16 weeks of gestation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of pre-eclampsia	Occurrence of pre-eclampsia during pregnancy	At childbirth (around 8 months)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2019
• Primary Completion (ACTUAL): December 7, 2021
• Study Completion (ACTUAL): December 7, 2021

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): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: 69HCL17_0516

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