University Hospital, Clermont-Ferrand
Clermont-Ferrand, 63000, France
Location contact
GUILLAUME FERRAND
CONTACT
MARTINE BONNIN
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NCT Number: NCT06588023
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.
Trial opening soon.
Get Notified18 year and older
Female
Observational
Clermont-Ferrand, 63000, France
GUILLAUME FERRAND
CONTACT
MARTINE BONNIN
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: During the entire cesarean procedure including anesthesia.
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: During the entire cesarean procedure including anesthesia.
Defined by the time-weighted average intraoperative PAS below a threshold of 110mmHg or above a threshold of 170mmHg. This measurement is commonly called TWA (Time Weighted Average), corresponding to the area between the chosen PAS threshold and the measured PAS curve, divided by the total measurement time.
Time frame: During the entire cesarean procedure including anesthesia.
Time frame: During the entire cesarean procedure including anesthesia.
Time frame: During the entire cesarean procedure including anesthesia.
Time frame: During the entire cesarean procedure including anesthesia.
Time frame: During the entire cesarean procedure including anesthesia.
Time frame: During the entire cesarean procedure including anesthesia.
Time frame: During the entire cesarean procedure including anesthesia.
Contact information is provided by the study sponsor or research team.
BONNIN
CONTACT
GUILLAUME FERRAND
CONTACT
University Hospital, Clermont-Ferrand
Other
Prevalence of Blood Pressure Complications During Cesarean Section in Pre-eclamptic Patients
Acronym: HOPE
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