CTRI/2024/04/064992招募中1 期
A randomised control study to evaluate the safety and efficacy of Levetiracetam in comparison to Magnesium Sulphate in the management of severe pre-eclampsia
BLDE(DU) Shri BM Patil medical College, Hospital and Resarch Center, Vijayapura4 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年4月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 4
- 主要终点
- To study the effeciacy and safety of Levetiracetam in prevention of seizures in Preeeclampsia
研究概览
简要总结
This study should help the Women who are suffering from preeclampsia to have an alternative drug Levetiracetam for prevention of convulsions
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Pregnant women with gestational age of more than or equal to 28 weeks presenting with features of severe pre-eclampsia and/ or imminent eclampsia, needing immediate delivery as per treating clinician’s decision
- •No contraindication to either of the study drugs 3.Patients giving written informed consent for investigations and the proposed intervention.
排除标准
- •1.Patients diagnosed with other causes of convulsions in pregnancy like cerebral malaria and epilepsy 2.Pregnant women with chronic hypertension without super-imposed pre-eclampsia 3.Pregnant females with fetal anomalies detected on USG 4.Pregnant women who already have deranged renal parameters.
结局指标
主要结局
To study the effeciacy and safety of Levetiracetam in prevention of seizures in Preeeclampsia
时间窗: WIthin 30 min of administeting the drug. At 24 hours of administering the drug. At delivery of the baby
次要结局
- To observe the adverse effects of Levetiracetam and Magnesium sulphate(For 5 days)
研究者
研究点 (4)
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