PreCarVasc: Evaluation of Cardiovascular Risk After Preeclampsia in General Practitioners and Patients

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06059937
Collaborator
(none)
200
1
12
16.6

Study Details

Study Description

Brief 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. 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Patient with pre-eclampsia

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evaluation of Cardiovascular Risk After Preeclampsia in General Practitioners and Patients
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Performing a blood pressure measurement by the general practitioner [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

  2. Performing a self-measurement of blood pressure [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

  3. Performing a cardiological consultation [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

  4. Performing a ambulatory measurement of blood pressure [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

  5. Performing a biological monitoring of blood (creatinine, LDL cholesterol, fasting glucose, albuminuria creatinuria ratio) [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.

  6. Screening and management of possible smoking [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

Secondary Outcome Measures

  1. Cardiovascular risk assessment by the general practitioner [Up to 5 years following pre eclampsia]

    Patient's cardiovascular risk evaluation by the general practitioner (low, medium, high or very high).

  2. Cardiovascular risk assessment by the patient [Up to 5 years following pre eclampsia]

    Patient's cardiovascular risk evaluation by the patient (low, medium, high or very high).

  3. Knowledge of pre-eclampsia status [Up to 5 years following pre eclampsia]

    Knowledge of the pre-eclampsia status of the patient by the general practitioner.

  4. Pre eclampsia information mode [Up to 5 years following pre eclampsia]

    How general practitioner is informed about pre-eclampsia

  5. Performing a blood pressure measurement [Up to one year following pre eclampsia]

    Actions implemented by the general practiotioner within the following specific tools as reported by the patient such as blood pressure measurement in the office.

  6. Performing a self-measurement of blood pressure [Up to one year following pre eclampsia]

    Actions implemented by the general practiotioner within the following specific tools as reported by the patient.such as self-measurement of blood pressure.

  7. Performing a cardiological consultation [Up to one year following pre eclampsia]

    Actions implemented by the general practiotioner within the following specific tools as reported by the patient such as cardiological consultation.

  8. Performing a ambulatory measurement of blood pressure [Up to one year following pre eclampsia]

    Actions implemented by the general practiotioner within the following specific tools as reported by the patient such as ambulatory measurement of blood pressure.

  9. Performing a biological monitoring of blood (creatinine, LDL cholesterol, fasting glucose, albuminuria creatinuria ratio) [Up to one year following pre eclampsia]

    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).

  10. Screening and management of possible smoking [Up to one year following pre eclampsia]

    Actions implemented by the general practiotioner within the following specific tools as reported by the patient such as screening and management of possible smoking.

  11. Rate of hypertension following pre-eclampsia [Up to 5 years following pre eclampsia]

    Composite endpoint of hypertension, stroke and/or coronary accident with 17;18

  12. Rate of stroke following pre-eclampsia [Up to 5 years following pre eclampsia]

    Composite endpoint of hypertension, stroke and/or coronary accident with 16;18

  13. Rate of coronary accident following pre-eclampsia [Up to 5 years following pre eclampsia]

    Composite endpoint of hypertension, stroke and/or coronary accident with 16;17

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients ≥ 18 years hospitalized for preeclampsia at the Nancy regional maternity hospital
Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU de NANCY Vandoeuvre les nancy France 54500

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

  • Study Chair: Nicolas GIRERD, MD-PhD, CHRU de NANCY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jean-Marc BOIVIN, Principal investigator, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT06059937
Other Study ID Numbers:
  • 2023-A00933-42
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jean-Marc BOIVIN, Principal investigator, Central Hospital, Nancy, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2023