PreeclampsiaPRECEDENCT05056701
Prediction of Chronic Kidney Disease Following Pre-eclampsia: Diagnosis and Early Care
A study testing annual follow-up during 10 years in people with Preeclampsia, run by Centre Hospitalier le Mans at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- annual follow-up during 10 years
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesFrance
- Study dates
- 30 May 2022to 30 May 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Chu Angers
Angers, 49000
Jean-François AUGUSTO, 02 41 35 36 37, JFAugusto@chu-angers.fr
- Recruiting
Centre Hospitalier Du Mans
Le Mans, 72000
Giorgina PICCOLI, 02 43 43 43 43, gpiccoli@ch-lemans.fr
About this study
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.
Read more
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
- Being tested
- annual follow-up during 10 years
- Keywords
- chronic kidney disease (CKD), preeclampsia
- Medical subject headings
- Pre-Eclampsia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
annual follow-up during 10 yearsOther
an annual follow-up is carried out systematically for a total of 10 years in order to detect the subsequent occurrence of CKD
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: annual follow-up during 10 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: until 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start30 May 2022
- Primary completion30 May 2037 (estimated)
- Study completion30 May 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056701
- Sponsor's protocol ID
- CHM-2020/S8/10
- Acronym
- PRECEDE
- Status last verified
- Aug 2024
- First submitted
- 16 Sep 2021
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Chronic Kidney Disease Following Pre-eclampsia: Diagnosis and Early Care
- ClinicalTrials.gov ID
- NCT05056701
- Acronym / sponsor ID
- PRECEDE / CHM-2020/S8/10
- Conditions
- Preeclampsia
- Keywords
- chronic kidney disease (CKD), preeclampsia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 May 2037 (estimated)
- Study completion
- 30 May 2037 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with preeclampsia | Experimental | Other: annual follow-up during 10 yearsPatient meeting the preeclampsia criteria or one of its complications (eclampsia, HELLP syndrome) according to the ISSHP 2018 definitions within the last 5 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| annual follow-up during 10 yearsan annual follow-up is carried out systematically for a total of 10 years in order to detect the subsequent occurrence of CKD | Other | patient with preeclampsia |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
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Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing annual follow-up during 10 years in people with Preeclampsia, run by Centre Hospitalier le Mans at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christelle JADEAU (+33 2 44 71 07 81, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of the Chronic Kidney Disease (CKD) (time frame: until 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.