Patients Hospitalized for Pre-eclampsiaPreCarVascNCT06059937
Evaluation of Cardiovascular Risk After Preeclampsia in General Practitioners and Patients
An observational study of Patients Hospitalized for Pre-eclampsia, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Pre-eclampsia is a disease characterized by placental damage leading to a cascade of complications during pregnancy. It is initially manifested by high blood pressure and the presence of albumin in the urine. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patients Hospitalized for Pre-eclampsia
- What is being tested?
- Patient with pre-eclampsia
- How many people
- 155 participants
- Where
- 1 siteFrance
- Study dates
- 26 Feb 2024to 11 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients ≥ 18 years of age who were hospitalized for preeclampsia
Who may be able to join
- Patients ≥ 18 years hospitalized for preeclampsia at the Nancy regional maternity hospital
Who cannot join
- Fetal death in utero;
- Adult Person subject to a legal protection measure (guardianship, curatorship, safeguard of justice);
- Person deprived of liberty by a judicial or administrative decision;
- Person subject to psychiatric care under constraint by virtue of articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Trial locations and contacts
1 site in 1 country.
About this study
Pre-eclampsia is a disease characterized by placental damage leading to a cascade of complications during pregnancy. It is initially manifested by high blood pressure and the presence of albumin in the urine. It can lead to emergency hospitalization in severe cases and cause major complications or even death in the mother and the fetus.
Several studies observing the outcome of patients with pre-eclampsia have shown an increased long-term cardiovascular risk in these patients, justifying regular medical follow-up with the treating physician and specialists, mainly cardiologists.
The main objective of this research is to describe the cardiovascular risk assessment actions implemented by the treating general practitioner in the year following pre-eclampsia (blood pressure measurement in the office, self-measurement of blood pressure, ABPM, cardiological consultation, biological monitoring of blood (creatininemia, LDL, fasting glycemia) or urine (albuminurie/creatininurie ratio), and screening and management of possible smoking).
- Conditions
- Patients Hospitalized for Pre-eclampsia
- Being tested
- Patient with pre-eclampsia
- Keywords
- pre-eclampsia, cardiovascular risk
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient with pre-eclampsiaOther
Cardiovascular risk assessment by the general practitioner in the year following pre-eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Performing a blood pressure measurement by the general practitioner
Description: Describe the cardiovascular risk assessment actions implemented by the general practitioner in the year following pre-eclampsia within the following specific monitoring tools such as blood pressure measurement in the office. Composite outcome with 2, 3, 4, 5 and 6
Measured: Up to one year following pre eclampsia
Performing a self-measurement of blood pressure
Description: Describe the cardiovascular risk assessment actions implemented by the general practitioner in the year following pre-eclampsia within the following specific monitoring tools such as self-measurement of blood pressure. Composite outcome with 2, 3, 4, 5 and 6
Measured: Up to one year following pre eclampsia
Performing a cardiological consultation
Description: Describe the cardiovascular risk assessment actions implemented by the general practitioner in the year following pre-eclampsia within the following specific monitoring tools such as cardiological consultation. Composite outcome with 2, 3, 4, 5 and 6
Measured: Up to one year following pre eclampsia
Performing a ambulatory measurement of blood pressure
Description: Describe the cardiovascular risk assessment actions implemented by the general practitioner in the year following pre-eclampsia within the following specific monitoring tools such as ambulatory measurement of blood pressure. Composite outcome with 2, 3, 4, 5 and 6
Measured: Up to one year following pre eclampsia
Performing a biological monitoring of blood (creatinine, LDL cholesterol, fasting glucose, albuminuria creatinuria ratio)
Description: Describe the cardiovascular risk assessment actions implemented by the general practitioner in the year following pre-eclampsia within the following specific monitoring tools such as biological monitoring of blood (creatinine, LDL, fasting glucose) or urine (Albuminuria/creatininuria ratio). Composite outcome with 2, 3, 4, 5 and 6.
Measured: Up to one year following pre eclampsia
Screening and management of possible smoking
Description: Describe the cardiovascular risk assessment actions implemented by the general practitioner in the year following pre-eclampsia within the following specific monitoring tools such as screening and management of possible smoking. Composite outcome with 1, 2, 3, 4 and 5
Measured: Up to one year following pre eclampsia
Secondary outcomes (13)
Cardiovascular risk assessment by the general practitioner
Patient's cardiovascular risk evaluation by the general practitioner (low, medium, high or very high).
Measured: Up to 5 years following pre eclampsia
Cardiovascular risk assessment by the patient
Patient's cardiovascular risk evaluation by the patient (low, medium, high or very high).
Measured: Up to 5 years following pre eclampsia
Knowledge of pre-eclampsia status
Knowledge of the pre-eclampsia status of the patient by the general practitioner.
Measured: Up to 5 years following pre eclampsia
Pre eclampsia information mode
How general practitioner is informed about pre-eclampsia
Measured: Up to 5 years following pre eclampsia
Performing a blood pressure measurement
Actions implemented by the general practiotioner within the following specific tools as reported by the patient such as blood pressure measurement in the office.
Measured: Up to one year following pre eclampsia
Performing a self-measurement of blood pressure
Actions implemented by the general practiotioner within the following specific tools as reported by the patient.such as self-measurement of blood pressure.
Measured: Up to one year following pre eclampsia
Performing a cardiological consultation
Actions implemented by the general practiotioner within the following specific tools as reported by the patient such as cardiological consultation.
Measured: Up to one year following pre eclampsia
Performing a ambulatory measurement of blood pressure
Actions implemented by the general practiotioner within the following specific tools as reported by the patient such as ambulatory measurement of blood pressure.
Measured: Up to one year following pre eclampsia
Performing a biological monitoring of blood (creatinine, LDL cholesterol, fasting glucose, albuminuria creatinuria ratio)
Actions implemented by the general practiotioner within the following specific tools as reported by the patient such as biological monitoring of blood (creatinine, LDL, fasting glucose) or urine (Albuminuria/creatininuria ratio).
Measured: Up to one year following pre eclampsia
Screening and management of possible smoking
Actions implemented by the general practiotioner within the following specific tools as reported by the patient such as screening and management of possible smoking.
Measured: Up to one year following pre eclampsia
Rate of hypertension following pre-eclampsia
Composite endpoint of hypertension, stroke and/or coronary accident with 17;18
Measured: Up to 5 years following pre eclampsia
Rate of stroke following pre-eclampsia
Composite endpoint of hypertension, stroke and/or coronary accident with 16;18
Measured: Up to 5 years following pre eclampsia
Rate of coronary accident following pre-eclampsia
Composite endpoint of hypertension, stroke and/or coronary accident with 16;17
Measured: Up to 5 years following pre eclampsia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start26 Feb 2024
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Hospitalized for Pre-eclampsiaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Marc BOIVIN, Central Hospital, Nancy, France
- Investigators
- Nicolas GIRERD, MD-PhD, Study chair, CHRU de NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059937
- Sponsor's protocol ID
- 2023-A00933-42
- Acronym
- PreCarVasc
- Status last verified
- Apr 2025
- First submitted
- 20 Jun 2023
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiovascular Risk After Preeclampsia in General Practitioners and Patients
- ClinicalTrials.gov ID
- NCT06059937
- Acronym / sponsor ID
- PreCarVasc / 2023-A00933-42
- Conditions
- Patients Hospitalized for Pre-eclampsia
- Keywords
- pre-eclampsia, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 29 Sep 2023 (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 is a disease characterized by placental damage leading to a cascade of complications during pregnancy. It is initially manifested by high blood pressure and the presence of albumin in the urine. It can lead to emergency hospitalization in severe cases and cause major complications or even death in the mother and the fetus.
Several studies observing the outcome of patients with pre-eclampsia have shown an increased long-term cardiovascular risk in these patients, justifying regular medical follow-up with the treating physician and specialists, mainly cardiologists.
The main objective of this research is to describe the cardiovascular risk assessment actions implemented by the treating general practitioner in the year following pre-eclampsia (blood pressure measurement in the office, self-measurement of blood pressure, ABPM, cardiological consultation, biological monitoring of blood (creatininemia, LDL, fasting glycemia) or urine (albuminurie/creatininurie ratio), and screening and management of possible smoking).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥ 18 years of age who were hospitalized for preeclampsia
Key inclusion criteria (1 listed)
- Patients ≥ 18 years hospitalized for preeclampsia at the Nancy regional maternity hospital
Key exclusion criteria (4 listed)
- Fetal death in utero;
- Adult Person subject to a legal protection measure (guardianship, curatorship, safeguard of justice);
- Person deprived of liberty by a judicial or administrative decision;
- Person subject to psychiatric care under constraint by virtue of articles L. 3212-1 and L. 3213-1 of the Public Health Code.
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 |
|---|---|---|
| Patient with pre-eclampsiaCardiovascular risk assessment by the general practitioner in the year following pre-eclampsia | Other | – |
Primary outcome
Performing a blood pressure measurement by the general practitioner
Time frame: Up to one year following pre eclampsia
Description: Describe the cardiovascular risk assessment actions implemented by the general practitioner in the year following pre-eclampsia within the following specific monitoring tools such as blood pressure measurement in the office. Composite outcome with 2, 3, 4, 5 and 6
Performing a self-measurement of blood pressure
Time frame: Up to one year following pre eclampsia
Description: Describe the cardiovascular risk assessment actions implemented by the general practitioner in the year following pre-eclampsia within the following specific monitoring tools such as self-measurement of blood pressure. Composite outcome with 2, 3, 4, 5 and 6
Performing a cardiological consultation
Time frame: Up to one year following pre eclampsia
Description: Describe the cardiovascular risk assessment actions implemented by the general practitioner in the year following pre-eclampsia within the following specific monitoring tools such as cardiological consultation. Composite outcome with 2, 3, 4, 5 and 6
Performing a ambulatory measurement of blood pressure
Time frame: Up to one year following pre eclampsia
Description: Describe the cardiovascular risk assessment actions implemented by the general practitioner in the year following pre-eclampsia within the following specific monitoring tools such as ambulatory measurement of blood pressure. Composite outcome with 2, 3, 4, 5 and 6
Performing a biological monitoring of blood (creatinine, LDL cholesterol, fasting glucose, albuminuria creatinuria ratio)
Time frame: Up to one year following pre eclampsia
Description: Describe the cardiovascular risk assessment actions implemented by the general practitioner in the year following pre-eclampsia within the following specific monitoring tools such as biological monitoring of blood (creatinine, LDL, fasting glucose) or urine (Albuminuria/creatininuria ratio). Composite outcome with 2, 3, 4, 5 and 6.
Screening and management of possible smoking
Time frame: Up to one year following pre eclampsia
Description: Describe the cardiovascular risk assessment actions implemented by the general practitioner in the year following pre-eclampsia within the following specific monitoring tools such as screening and management of possible smoking. Composite outcome with 1, 2, 3, 4 and 5
13 secondary outcomes
Cardiovascular risk assessment by the general practitioner
Time frame: Up to 5 years following pre eclampsia
Cardiovascular risk assessment by the patient
Time frame: Up to 5 years following pre eclampsia
Knowledge of pre-eclampsia status
Time frame: Up to 5 years following pre eclampsia
Pre eclampsia information mode
Time frame: Up to 5 years following pre eclampsia
Performing a blood pressure measurement
Time frame: Up to one year following pre eclampsia
Performing a self-measurement of blood pressure
Time frame: Up to one year following pre eclampsia
Performing a cardiological consultation
Time frame: Up to one year following pre eclampsia
Performing a ambulatory measurement of blood pressure
Time frame: Up to one year following pre eclampsia
Performing a biological monitoring of blood (creatinine, LDL cholesterol, fasting glucose, albuminuria creatinuria ratio)
Time frame: Up to one year following pre eclampsia
Screening and management of possible smoking
Time frame: Up to one year following pre eclampsia
Rate of hypertension following pre-eclampsia
Time frame: Up to 5 years following pre eclampsia
Rate of stroke following pre-eclampsia
Time frame: Up to 5 years following pre eclampsia
Rate of coronary accident following pre-eclampsia
Time frame: Up to 5 years following pre eclampsia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
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. This study is not recruiting at the moment.
Nicolas GIRERD, MD-PhD study chair
CHRU de NANCY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Hospitalized for Pre-eclampsia, run by Central Hospital, Nancy, France at 1 site 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 1 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: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performing a blood pressure measurement by the general practitioner (time frame: Up to one year following pre eclampsia). The study lists 6 primary outcomes in all. 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 2 May 2025.