Prediction of Chronic Kidney Disease Following Pre-eclampsia: Diagnosis and Early Care (PRECEDE)
Primary Purpose
Preeclampsia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
annual follow-up during 10 years
Sponsored by
About this trial
This is an interventional prevention trial for Preeclampsia focused on measuring chronic kidney disease (CKD), preeclampsia
Eligibility Criteria
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
Sites / Locations
- Chu Angers
- Centre Hospitalier Du MansRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patient with preeclampsia
Arm Description
Patient meeting preeclampsia criteria according to International Society for the Study of Hypertension in Pregnancy (ISSHP) 2018 definitions
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05056701
First Posted
September 16, 2021
Last Updated
September 28, 2021
Sponsor
Centre Hospitalier le Mans
1. Study Identification
Unique Protocol Identification Number
NCT05056701
Brief Title
Prediction of Chronic Kidney Disease Following Pre-eclampsia: Diagnosis and Early Care
Acronym
PRECEDE
Official Title
Prediction of Chronic Kidney Disease Following Pre-eclampsia: Diagnosis and Early Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2021 (Actual)
Primary Completion Date
August 5, 2036 (Anticipated)
Study Completion Date
August 5, 2036 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier le Mans
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
chronic kidney disease (CKD), preeclampsia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient with preeclampsia
Arm Type
Experimental
Arm Description
Patient meeting preeclampsia criteria according to International Society for the Study of Hypertension in Pregnancy (ISSHP) 2018 definitions
Intervention Type
Other
Intervention Name(s)
annual follow-up during 10 years
Intervention Description
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 Measure Information:
Title
prevalence of the Chronic Kidney Disease (CKD)
Description
prevalence of the CKD is measured by the the rate of new CKD Diagnoses (according to the standard definitions)
Time Frame
until 10 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle JADEAU
Phone
02 44 71 07 81
Email
cjadeau@ch-lemans.fr
Facility Information:
Facility Name
Chu Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François AUGUSTO
Phone
02 41 35 36 37
Email
JFAugusto@chu-angers.fr
Facility Name
Centre Hospitalier Du Mans
City
Le MANS
ZIP/Postal Code
72000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgina PICCOLI
Phone
02 43 43 43 43
Email
gpiccoli@ch-lemans.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prediction of Chronic Kidney Disease Following Pre-eclampsia: Diagnosis and Early Care
We'll reach out to this number within 24 hrs