Association Between Pococyturia and Pre-eclampsia Severity

NCT03316391 | Completed

• 1 other identifier: 69HCL17_0517
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Pre-eclampsia

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

Other: Dosage of urinary podocyturia

Interventions

Dosage of urinary podocyturia OTHER

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

Pre-eclampsia

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Service de gynécologie-obstétrique

Pierre-Bénite, Rhône, 69495, France

Location

Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France

Bron, 69677, France

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 20, 2017
• Study Start: May 22, 2019
• Primary Completion: March 2, 2021
• Study Completion: March 2, 2021
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)