NCT06588023

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pre-eclampsia
• Pre-Eclampsia, Severe

Interventions

Type	Name	Description
OTHER	Observational study to evaluate professional practices	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).

Timeline

• Start date: 2024-09-05
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: France