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Recruiting NCT05056701

Prediction of Chronic Kidney Disease Following Pre-eclampsia: Diagnosis and Early Care

No phase Interventional Preeclampsia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: annual follow-up during 10 years.
Who it may be relevant to
Registry conditions: Preeclampsia. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Pre-eclampsia (PE) is a pregnancy-associated syndrome of variable severity, classically defined by the combination of hypertension and proteinuria in a previously non-hypertensive or proteinuric patient. These symptoms normally resolve within 2-3 months after delivery regardless of the severity of the pre-eclampsia. Regardless of its definition, preeclampsia is associated with an increased risk of obstetric events and, for the mother, an increased risk of developing chronic kidney disease (CKD), hypertension, diabetes and cardiovascular disease in the broad sense. The relationship between preeclampsia and Chronic Kidney Disease is, however, complex and not fully understood. Investigator proposes an interventional study to identify the diagnosis of Chronic Kidney Disease in patients who have developed an episode of Preeclampsia.

Interventions

  • Other annual follow-up during 10 years
    an annual follow-up is carried out systematically for a total of 10 years in order to detect the subsequent occurrence of CKD

Primary outcome measures

  • prevalence of the Chronic Kidney Disease (CKD) [Time frame: until 10 years]

Eligibility criteria

Inclusion criteria

  • Meeting the preeclampsia criteria or one of its complications (eclampsia, HELLP syndrome) according to the ISSHP 2018 definitions within the last 5 years
  • Having signed the informed consent
  • Person affiliated to social security

Exclusion criteria

  • Patient with mental disability or language barrier preventing understanding of the study or consent
  • Person deprived of liberty by judicial or administrative decision
  • Person under forced psychiatric care
  • Person subject to a legal protection measure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

France · 2 centers
  • Chu Angers — Angers
  • Centre Hospitalier Du Mans — Le Mans

Identifiers

NCT: NCT05056701 · CHM-2020/S8/10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗