Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588023
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Prevalence of Blood Pressure Complications During Cesarean Section in Pre-eclamptic Patients HOPE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prevalence of Blood Pressure Complications During Cesarean Section in Pre-eclamptic Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOPE
Brief 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 BP14090mmHg and proteinuria ampgt 03gday 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 andor 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
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None