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

ConditionsPre-eclampsia Pre-Eclampsia, Severe

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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 \&gt; 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Urgent Cesarean (Red code).

Patient refusal.

Patient does not understand French.

Individual protection measures : guardianship, curatorship.

Trial population

Pre-eclamptic patients undergoing cesarean section in the maternity wards of the Clermont-Ferrand and Lille university hospitals

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Observational study to evaluate professional practices
Other intervention
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).

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Lille University Hospital1 intervention

Group B: Clermont-Ferrand University Hospital1 intervention

Trial outcomes

Primary outcomes

Hemodynamic events.

Prevalence of the occurrence of events such as maternal arterial hypotension and/or arterial hypertension during a cesarean section in a known pre-eclamptic patient.

Time frame