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

NCT05056701 | Recruiting

• 1 other identifier: CHM-2020/S8/10
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Preeclampsia

Keywords

chronic kidney disease (CKD); preeclampsia

Outcome Measures

Primary Outcomes (1)

• prevalence of the Chronic Kidney Disease (CKD)

  prevalence of the CKD is measured by the the rate of new CKD Diagnoses (according to the standard definitions)

  until 10 years

Study Arms (1)

patient with preeclampsia

EXPERIMENTAL

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

Other: annual follow-up during 10 years

Interventions

annual follow-up during 10 years OTHER

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

patient with preeclampsia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (2)

Chu Angers

Angers, 49000, France

NOT YET RECRUITING

Centre Hospitalier Du Mans

Le Mans, 72000, France

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christelle JADEAU

CONTACT

+33 2 44 71 07 81; cjadeau@ch-lemans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 24, 2021
• Study Start: May 30, 2022
• Primary Completion (Estimated): May 30, 2037
• Study Completion (Estimated): May 30, 2037
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)