CTRI/2010/091/001285已完成2 期
abetalol vs Magnesium Sulfate for Prevention of Eclampsia Trial ( LAMPET TRIAL )Acronym : LAMPET TRIA
Govt Medical College Kozhikode0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion criteria
- •Adult females aged between 15-60 years of age with a diagnosis of severe preeclampsia who are deemed to be at sufficient risk to warrant seizure prophylaxis with MgSO4.
- •Any patient with preeclampsia (BP > 140 systolic and/or > 90 mmHg diastolic with 1+ or more proteinuria [or a 24 hour specimen with > 300 mg/day]), chronic hypertension (or superimposed preeclampsia), or gestational hypertension deemed to be at risk for eclamptic convulsions and who would routinely be treated in the participating institution with some form of anti-seizure prophylaxis during labor and delivery
排除标准
- •Exclusion Criteria:
- •Any patient for whom informed consent cannot be obtained.
- •Any patient who has received an antihypertensive medication within 6 hours prior to enrollment will not be eligible but those who have received antihypertensive medications other than beta-blockers or magnesium sulfate may still be enrolled as long as they have not been given a dose within the 6 hours prior to enrollment. If a patient has received MgSO4 or a short acting beta-blocker or calcium channel blocker more than 12 hours prior to enrollment or if they have received a long acting beta-blocker more than 24 hours before enrollment she may still be considered eligible. This stipulation will allow increased recruitment of patients especially those with chronic hypertension and those transferred from outlying institutions. We expect these patients to be a minority of the enrollment.
- •A history of bronchial asthma, emphysema, heart block, angina, cardiomyopathy or myocardial infarction.
- •Any history or signs of congestive cardiac failure, or arrhythmia with a ventricular rate of less than 60 bpm.
- •Patients with severe mental or physical disorders which, in the opinion of the investigators, might affect responsiveness to therapy or any other aspect of the study.
- •Patients who are allergic to drugs with a chemical structure similar to labetalol or magnesium sulfate.
- •Patients given magnesium sulfate, labetalol or short acting beta blockers or calcium channel blockers less than 12 hours prior to enrollment in the study.
- •Evidence of fetal distress or fetal anomalies.
- •Inability to secure intravenous access.
- •Patient's primary physician declines to enroll patient in study
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