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Not yet recruiting NCT06588023

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

— Observational Pre-eclampsia Pre-Eclampsia, Severe

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational study to evaluate professional practices.
Who it may be relevant to
Registry conditions: Pre-eclampsia, Pre-Eclampsia, Severe. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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).

Primary outcome measures

  • Hemodynamic events. [Time frame: During the entire cesarean procedure including anesthesia.]
Secondary outcome measures (5)
  • Duration of maternal hypotensive or hypertensive episodes. [Time frame: During the entire cesarean procedure including anesthesia.]
  • Number of maternal hypotensive and/or hypertensive episodes. [Time frame: During the entire cesarean procedure including anesthesia.]
  • Occurrence of major adverse events. [Time frame: During the entire cesarean procedure including anesthesia.]
  • Nature and dose of local anesthetic administered [Time frame: During the entire cesarean procedure including anesthesia.]
  • Nature and management of antihypertensive drugs during cesarean section. [Time frame: During the entire cesarean procedure including anesthesia.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • University Hospital, Clermont-Ferrand — Clermont-Ferrand

Identifiers

NCT: NCT06588023 · M24BM0715

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗