Clinical trial NCT06588023: Prevalence of Blood Pressure Complications During Cesarean Section in Pre-eclamptic Patients (HOPE)
Official title: Prevalence of Blood Pressure Complications During Cesarean Section in Pre-eclamptic Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pre-eclampsia
Pre-Eclampsia, Severe
Keywords: cesarean section
Blood pressure complications
pre-eclampsia
hypertension
hypotension
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
First posted: 2024-09-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre-eclamptic patients undergoing cesarean section in the maternity wards of the Clermont-Ferrand and Lille university hospitals

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 (BP≥140/90mmHg) and proteinuria \&amp;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: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Urgent Cesarean (Red code).
* Patient refusal.
* Patient does not understand French.
* Individual protection measures : guardianship, curatorship.

Primary outcomes:
measure: Hemodynamic events.
timeFrame: During the entire cesarean procedure including anesthesia.
Secondary outcomes:
measure: Duration of maternal hypotensive or hypertensive episodes.
timeFrame: During the entire cesarean procedure including anesthesia.
measure: Number of maternal hypotensive and/or hypertensive episodes.
timeFrame: During the entire cesarean procedure including anesthesia.
measure: Occurrence of major adverse events.
timeFrame: During the entire cesarean procedure including anesthesia.
measure: Nature and dose of local anesthetic administered
timeFrame: During the entire cesarean procedure including anesthesia.
measure: Nature and management of antihypertensive drugs during cesarean section.
timeFrame: During the entire cesarean procedure including anesthesia.
Other outcomes:
measure: Maximum dosages and cumulative doses of Noradrenaline during cesarean section.
timeFrame: During the entire cesarean procedure including anesthesia.
measure: Total vascular filling volume.
timeFrame: During the entire cesarean procedure including anesthesia.
measure: Total diuresis.
timeFrame: During the entire cesarean procedure including anesthesia.
Locations:
city: Clermont-ferrand
country: France
facility: University Hospital, Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: MARTINE BONNIN
role: PRINCIPAL_INVESTIGATOR
References: