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Clinical Trials/NCT03316391
NCT03316391
Completed
Not Applicable

Prospective Study : Association Between Pococyturia and Pre-eclampsia Severity

Hospices Civils de Lyon2 sites in 1 country14 target enrollmentMay 22, 2019
ConditionsPre-Eclampsia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-Eclampsia
Sponsor
Hospices Civils de Lyon
Enrollment
14
Locations
2
Primary Endpoint
Severity of pre-eclampsia
Status
Completed
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 22, 2019
End Date
March 2, 2021
Last Updated
9 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (2)

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