Peripartum Anesthetic Management of Patients With Preeclampsia: Prospective Cohort International Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Type of Anesthesia
研究概览
简要总结
The investigators will conduct a prospective, observational multicentral international study of perioperative management of patients with preeclampsia. The data will be collected from the maternity files and information systems of the medical centers including obstetric, anesthetic and neonatal parameters according to the attached Excel data table.
Results of the study will help to improve the management of patients with preeclampsia and will help to understand the nature and rate of complications. In addition, the study will help in comparing collected data to the data in the literature and as a result improve the safety of care and service that these patient receive in the institution.
详细描述
In recent years, there has been a growing interest in anesthetic management of parturients diagnosed with preeclampsia.
The management of patients with preeclampsia is influenced by maternal conditions that include airway changes, coagulation dysfunction and significant hemodynamic changes.
Without changing regular practice the investigators will observe and collect data about: the type of anesthesia during surgery, perioperative monitoring and management of these patients (please see study outcomes). Complications reported in the literature include significant elevated blood pressure during laryngoscopy and development of intracranial hemorrhage, spinal/epidural bleeding during neuraxial anesthesia in patients with preeclampsia, and coagulation abnormalities.
Although the number of patients diagnosed with preeclampsia is estimated at five to ten percent of the general maternity population, there is a lack of prospective studies regarding the anesthetic management, obstetric complications and neonatal outcomes. In most centers the data regarding the rate of general anesthesia for cesarean section, the difficulty in performing neuraxial anesthesia, complications related to coagulation dysfunction and other complications, is limited.
In studies published by gynecologists or neonatologists, there is a significant lack of data relevant to the daily practice of anesthesiologists.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Parturient with diagnosis of preeclampsia for Cesarean Section
排除标准
- 未提供
结局指标
主要结局
Type of Anesthesia
时间窗: Final Type of Anesthesia will be defined during the Cesarean Section (during the operation)
Final Type of Anesthesia for Cesarean Section including General or Regional Anesthesia
次要结局
- Apgar score(Will be defined at 1 and 5 minute after fetal delivery during surgery)
- Perioperative anesthetic management(Beginning from preoperative assessment by anesthesiologist to discharge from Post-Anesthesia Care Unit (PACU) / ICU (Intensive Care Unit) assessed up to 5 days)
- Postoperative pain management(From the start of surgery to the end of postoperative care in recovery unit assessed up to 5 days)
- Invasive monitoring use(During surgery)
- Anesthetic complications(Anesthetic complications of patient as result of anesthetic management during the surgery until discharge from the hospital, assessed up to 5 days)
- Admission to ICU unit(Admission to during current hospitalization and until discharge from the hospital, assessed up to 5 days)
- Use of blood products(Type and total amount of blood products that administered to patient during the surgery and during the hospitalization, assessed up to 5 days)
- Indication for surgery(Indication for Cesarean Section will be defined by obstetrician before the operation)
- Obstetric complications(Obstetric complications of patient during the surgery until discharge from the hospital, assessed up to 5 days)
- Admission to NICU(Admission to NICU unit during the surgery until maternal discharge from the hospital, assessed up to 5 days)
- Neonatal complications(Neonatal complications during the surgery until maternal discharge from the hospital, assessed up to 5 days)
研究者
Alexander Ioscovich
Director of Obstetric Anesthesia Unit
Shaare Zedek Medical Center