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Набор скоро начнётся NCT06588023

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

— Наблюдательное Pre-eclampsia Pre-Eclampsia, Severe

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Observational study to evaluate professional practices.
Кому может быть актуально
Состояния в реестре: Pre-eclampsia, Pre-Eclampsia, Severe. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Другое 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).

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • University Hospital, Clermont-Ferrand — Clermont-Ferrand

Идентификаторы

NCT: NCT06588023 · M24BM0715

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗