PEPOD2: Association Between Pococyturia and Pre-eclampsia Severity

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03316391

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-Eclampsia	Other: Dosage of urinary podocyturia

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Prospective Study : Association Between Pococyturia and Pre-eclampsia Severity

Actual Study Start Date :

May 22, 2019

Anticipated Primary Completion Date :

Mar 22, 2025

Anticipated Study Completion Date :

Mar 22, 2025

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France	Bron		France	69677

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT03316391

Other Study ID Numbers:

69HCL17_0517

First Posted:

Oct 20, 2017

Last Update Posted:

Mar 23, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Eclampsia

Pre-Eclampsia

Study Results

No Results Posted as of Mar 23, 2022