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

Preeclampsia Clinical Trial

— PRECEDE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05056701
• Other study ID #: CHM-2020/S8/10
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: August 5, 2036

Study information

• Verified date: September 2021
• Source: Centre Hospitalier le Mans
• Contact: Christelle JADEAU
• Phone: 02 44 71 07 81
• Email: cjadeau[@]ch-lemans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 5, 2036
• Est. primary completion date: August 5, 2036
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meeting the preeclampsia criteria according to the ISSHP 2018 definitions

• Having signed the informed consent

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

Related Conditions & MeSH terms

• Eclampsia
• Kidney Diseases
• Pre-Eclampsia
• Preeclampsia
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
France	Chu Angers	Angers
France	Centre Hospitalier Du Mans	Le MANS

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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