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临床试验/NCT03412552
NCT03412552已完成不适用

Risk Analysis of Intensive Care Management on Maternal and Fetal Outcome of Severe Preeclampsia and Eclampsia

Cairo University1 个研究点 分布在 1 个国家目标入组 1,238 人开始时间: 2015年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1,238
试验地点
1
主要终点
control of blood pressure

研究概览

简要总结

Laboratory monitoring of patients included serial measurement of complete blood cell count, liver function tests, coagulation profile, and renal function tests.

ICU management during conduction of the research study included the following:

Control of convulsions using magensium sulphate. Control of blood pressure Diastolic blood pressure above 110 mmHg, nifedipine was administered.A plasma volume expansion with saline was used in all women to maintain sufficient intravascular volume. Delivery was performed immediately after hemodynamic stabilization and clinical control of general condition .

详细描述

Laboratory monitoring of patients included serial measurement of complete blood cell count, liver function tests, coagulation profile, and renal function tests.

ICU management included the following:

Control of convulsions by Loading dose of magensium sulphate (4-6g I.V), given over 20 minutes in 100 ml of dextrose then Maintenance dose (4-6g) magensium sulphate in 500 cc dextrose given over 8 hours using continuous IV drip.Control of blood pressure if Diastolic blood pressure above 110 mmHg, nifedipine was administered. Delivery was performed immediately after hemodynamic stabilization and clinical control of general condition .Termination of gestation decision was based on the the presence of maternal complications, fetal distress.After delivery the patient is retrurned to ICU under clinical and careful observation of the following:Heart rate, blood pressure,every 15 min,Temperature and respiratory rate ,evey 4 hours. Duration of admission in the ICU was assessed

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women with severe preeclampsia or eclampsia or HELLP syndrome admitted to ICU

排除标准

  • Non eclamptic causes of fits, including hysterical causes and epilepsy

研究组 & 干预措施

severe preeclampsia without HELLP syndrome

severe preeclampsia if they met one or more of the following criteria of The American College of Obstetricians and Gynecologists (10): systolic blood pressure >160 mm/ Hg or diastolic blood pressure >110 mm/Hg, headache, epigastric or right-upper-quadrant pain, visual disturbances,pulmonary edema, and proteinuria (urinary protein level >5 g/24 h).Women with severe preeclampsia selected for analysis also met all of the following laboratory criteria: platelet count ≥150,000/ mm3, serum lactate dehydrogenase <600 IU /dL, serum total bilirubin <1.2 mg/dL and serum aspartate aminotransferase <70IU/L

干预措施: MgSO4 (Drug)

eclampsia without HELLP syndrome

Eclampsia was defined as tonic-clonic seizures occurring in patient diagnosed by preeclampsia patient. Any causes for convulsion other than eclampsia were excluded

干预措施: MgSO4 (Drug)

eclampsia with HELLP syndrome

Eclampsia was defined as tonic-clonic seizures occurring in patient diagnosed by preeclampsia patient. Any causes for convulsion other than eclampsia were excluded.HELLP syndrome was defined by the clinical presentation of PET in association with thrombocytopenia (<150.000 cells/ul), hemolysis and elevated liver enzmes (elevated transaminases and lactic dyhydrogenases activities)

干预措施: MgSO4 (Drug)

HELLP syndrome without eclampsia

HELLP syndrome was defined by the clinical presentation of PET in association with thrombocytopenia (<150.000 cells/ul), hemolysis and elevated liver enzmes (elevated transaminases and lactic dyhydrogenases activities)

干预措施: MgSO4 (Drug)

结局指标

主要结局

control of blood pressure

时间窗: 24 hours after delivery

keeping blood pressure at or below 140/90

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Maged

professor

Cairo University

研究点 (1)

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