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

NCT ID: NCT05056701

Last Updated: 2024-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-30

Study Completion Date

2037-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Preeclampsia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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patient with preeclampsia

Patient meeting the preeclampsia criteria or one of its complications (eclampsia, HELLP syndrome) according to the ISSHP 2018 definitions within the last 5 years

Group Type EXPERIMENTAL

annual follow-up during 10 years

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier le Mans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Angers

Angers, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Du Mans

Le Mans, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christelle JADEAU

Role: CONTACT

+33 2 44 71 07 81

Facility Contacts

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Jean-François AUGUSTO

Role: primary

02 41 35 36 37

Giorgina PICCOLI

Role: primary

02 43 43 43 43

Other Identifiers

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CHM-2020/S8/10

Identifier Type: -

Identifier Source: org_study_id

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