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

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 Overview

• Status: Completed
• Conditions: Patients Hospitalized for Pre-eclampsia
• Intervention / Treatment: Other: Patient with pre-eclampsia

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• France
  • Vandoeuvre les nancy, France, 54500
    • CHRU de NANCY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients ≥ 18 years of age who were hospitalized for preeclampsia

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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.	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	Up to one year following pre eclampsia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular risk assessment by the general practitioner	Patient's cardiovascular risk evaluation by the general practitioner (low, medium, high or very high).	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).	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.	Up to 5 years following pre eclampsia
Pre eclampsia information mode	How general practitioner is informed about pre-eclampsia	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.	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.	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.	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.	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).	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.	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	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	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	Up to 5 years following pre eclampsia

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Chair: Nicolas GIRERD, MD-PhD, CHRU de NANCY

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Actual): February 11, 2025
• Study Completion (Actual): February 11, 2025

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: cardiovascular risk; pre-eclampsia
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: 2023-A00933-42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No