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Completed

NCT Number: NCT03316391

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.

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Key information

Conditions

Pre-eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Service de gynécologie-obstétrique, Pierre-Bénite, Rhône, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dosage of urinary podocyturia

Other

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

Primary outcomes

  1. Severity of pre-eclampsia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Prospective Study : Association Between Pococyturia and Pre-eclampsia Severity

Acronym: PEPOD2

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 20, 2017
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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