Prevalence of Blood Pressure Complications During Cesarean Section in Pre-eclamptic Patients (HOPE)
NCT ID: NCT06588023
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
80 participants
OBSERVATIONAL
2024-09-05
2025-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lille University Hospital
Pre-eclamptic patients undergoing a cesarean section at the maternity ward of Lille University Hospital.
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).
Clermont-Ferrand University Hospital
Pre-eclamptic patients undergoing a cesarean section at the maternity ward of Clermont-Ferrand University Hospital.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient refusal.
* Patient does not understand French.
* Individual protection measures : guardianship, curatorship.
18 Years
FEMALE
No
Sponsors
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University Hospital, Lille
OTHER
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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MARTINE BONNIN
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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University Hospital, Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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M24BM0715
Identifier Type: -
Identifier Source: org_study_id
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