Prevalence of Blood Pressure Complications During Cesarean Section in Pre-eclamptic Patients (HOPE)

University Hospital, Clermont-Ferrand

Status: Not yet enrolling

Conditions: Pre-Eclampsia, Severe; Pre-eclampsia

Treatments: Other: Observational study to evaluate professional practices

Study type: Observational

Funder types: Other

Identifiers

NCT06588023

M24BM0715

Details and patient eligibility

About

Preeclampsia (PE) is an obstetric placental vascular pathology with a prevalence of 2 to 5% of pregnant women. It is defined by learned societies by the association of high blood pressure (BP≥140/90mmHg) and proteinuria > 0.3g/day. The last French Maternal Mortality Report 2024 places cardiovascular complications among the main causes of maternal death. PE has an increasing number of deaths in 2016-2018 and significant preventability (66%).

Cesarean sections in pre-eclamptic patients are difficult procedures and, do not benefit from any specific recommendations. Cesarean section is promptly performed under regional anesthesia by spinal anesthesia or spinal anesthesia with combined epidural, techniques that cause maternal arterial hypotension with consequences for the baby.

These hypertensive patients, often on antihypertensives, challenge the anesthesiologist to manage the hemodynamic balance between the risk of arterial hypotension generated by the anesthesia corrected by vasoactive amines and the risk of major hypertension secondary to their management. The major risk in these patients with low platelet counts is hemorrhagic stroke.

Our study is an observational, bi-centric study between the maternity wards of the Clermont Ferrand and Lille University Hospitals.

It consists of collecting data prospectively on all pre-eclamptic patients undergoing a non-urgent cesarean section.

The objective is to observe the management of hemodynamics and calculate the prevalence of complications such as maternal hypotension and/or hypertension through the implementation of non-invasive monitoring (ClearSight).

Patients meeting the inclusion and non-inclusion criteria may be included in the study by an investigator after having given a non-opposition agreement after having received clear and fair information about the study.

In any case, the care of patients participating in the study will not be modified in any way compared to the usual practices of the services.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre-eclamptic patient according to the criteria defined by SFAR 2020.
• Indication of organised or semi-urgent cesarean section (Green or Orange code).
• Adult patient, benefiting from a social security system.
• Oral non-opposition to participation in the study.

Exclusion criteria

• Urgent Cesarean (Red code).
• Patient refusal.
• Patient does not understand French.
• Individual protection measures : guardianship, curatorship.

Trial design

80 participants in 2 patient groups

Lille University Hospital

Description:

Pre-eclamptic patients undergoing a cesarean section at the maternity ward of Lille University Hospital.

Treatment:

Other: Observational study to evaluate professional practices

Clermont-Ferrand University Hospital

Description:

Pre-eclamptic patients undergoing a cesarean section at the maternity ward of Clermont-Ferrand University Hospital.

Treatment:

Other: Observational study to evaluate professional practices