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

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ClinicalTrials.gov Identifier: NCT05056701
Recruitment Status : Recruiting
First Posted : September 24, 2021
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier le Mans

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.


Condition or disease Intervention/treatment Phase
Preeclampsia Other: annual follow-up during 10 years Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prediction of Chronic Kidney Disease Following Pre-eclampsia: Diagnosis and Early Care
Actual Study Start Date : August 5, 2021
Estimated Primary Completion Date : August 5, 2036
Estimated Study Completion Date : August 5, 2036

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: patient with preeclampsia
Patient meeting preeclampsia criteria according to International Society for the Study of Hypertension in Pregnancy (ISSHP) 2018 definitions
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 :
  1. prevalence of the Chronic Kidney Disease (CKD) [ Time Frame: until 10 years ]
    prevalence of the CKD is measured by the the rate of new CKD Diagnoses (according to the standard definitions)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05056701


Contacts
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Contact: Christelle JADEAU 02 44 71 07 81 cjadeau@ch-lemans.fr

Locations
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France
Chu Angers Not yet recruiting
Angers, France, 49000
Contact: Jean-François AUGUSTO    02 41 35 36 37    JFAugusto@chu-angers.fr   
Centre Hospitalier Du Mans Recruiting
Le MANS, France, 72000
Contact: Giorgina PICCOLI    02 43 43 43 43    gpiccoli@ch-lemans.fr   
Sponsors and Collaborators
Centre Hospitalier le Mans
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Responsible Party: Centre Hospitalier le Mans
ClinicalTrials.gov Identifier: NCT05056701    
Other Study ID Numbers: CHM-2020/S8/10
First Posted: September 24, 2021    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier le Mans:
chronic kidney disease (CKD)
preeclampsia
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Pre-Eclampsia
Eclampsia
Urologic Diseases
Renal Insufficiency
Hypertension, Pregnancy-Induced
Pregnancy Complications