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NCT Number: NCT06059937

Evaluation of Cardiovascular Risk After Preeclampsia in General Practitioners and Patients

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).

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Key information

Conditions

Patients Hospitalized for Pre-eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHRU de NANCY

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient with pre-eclampsia

Other

Cardiovascular risk assessment by the general practitioner in the year following pre-eclampsia

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  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

Secondary outcomes

  1. Cardiovascular risk assessment by the general practitioner

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to 5 years following pre eclampsia

    How general practitioner is informed about pre-eclampsia

  5. Performing a blood pressure measurement

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to 5 years following pre eclampsia

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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: PreCarVasc

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2023
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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