Prevalence of Blood Pressure Complications During Cesarean Section in Pre-eclamptic Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Hemodynamic events.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-eclamptic patient according to the criteria defined by SFAR
- •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.
排除标准
- •Urgent Cesarean (Red code).
- •Patient refusal.
- •Patient does not understand French.
- •Individual protection measures : guardianship, curatorship.
结局指标
主要结局
Hemodynamic events.
时间窗: 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.
次要结局
- Duration of maternal hypotensive or hypertensive episodes.(During the entire cesarean procedure including anesthesia.)
- Number of maternal hypotensive and/or hypertensive episodes.(During the entire cesarean procedure including anesthesia.)
- Occurrence of major adverse events.(During the entire cesarean procedure including anesthesia.)
- Nature and dose of local anesthetic administered(During the entire cesarean procedure including anesthesia.)
- Nature and management of antihypertensive drugs during cesarean section.(During the entire cesarean procedure including anesthesia.)