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临床试验/CTRI/2025/03/082251
CTRI/2025/03/082251招募中不适用

Traditional (24 hours) versus Abbreviated (6 hours) post partum magnesium sulphate therapy in patients with pre eclampsia with severe features: A Randomized Controlled Trial

ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年3月17日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Effectiveness of MgSo4

研究概览

简要总结

This study is a randomized, double blind, parallel group, active control trial comparing the benefits of MgSO4 infusion for traditional 24 hours postpartum versus abbreviated 6 hours postpartum in patients with pre eclampsia with severe features. The primary objective of the study is To assess MgSO4 infusion for 24 hours postpartum is as effective as 6 hours postpartum in patients with preeclampsia with severe features. The secondary objectives being to assess total time of magnesium sulphate infusion prior to birth, occurrence of seizures postpartum number of seizures in post partum period and  time and duration of postpartum convulsion, postpartum bleeding, respiratory distress, time to onset of ambulation post partum and breastfeeding start time, use of postpartum antihypertensives, maternal death. Study population will be All Pregnant women diagnosed with pre-eclampsia with severe features at more than 20 weeks gestation willing to participate in study will be included in study. Patients refusing to give consent , patient with prior history of eclampsia before delivery, diagnosed with HELLP syndrome, known case of epilepsy, pre eclampsia with additional pathology such as renal failure, acute pulmonary edema, decompensated diabetes mellitus, autoimmune diseases, or hypertensive encephalopathy are excluded from the study. The expected outcome would be Abbreviated (6 hours) post partum magnesium sulphate therapy in patients with pre eclampsia with severe features is as effective as Traditional (24 hours) post partum magnesium sulphate therapy. Study population will be evaluated for 24 hours postpartum and total duration of study will be 2 years.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant women diagnosed with pre-eclampsia with severe features at more than 20 weeks gestation Severe pre-eclampsia diagnosed when A patient have arterial pressures of 140/90 mmHg or higher at least twice separated by 4 hours with or without proteinuria equal to or greater than 0.3gms and have one or more of the following clinical criteria Severe hypertension (160/110 mmHg), if Neurological symptoms, epigastric pain, or Laboratory abnormalities Increase in creatinine, Thrombocytopenia, Elevation of liver enzymes, When the woman was known to have chronic hypertension and have one of the aforementioned criteria plus the presence of proteinuria equal to or greater than 0.3 gm, it is considered pre eclampsia with severe features.

排除标准

  • Eclampsia before delivery,
  • HELLP syndrome,
  • Pre-eclampsia with additional pathology such as Renal failure, Acute pulmonary edema, Decompensated diabetes mellitus, Autoimmune diseases, or Hypertensive encephalopathy.

结局指标

主要结局

Effectiveness of MgSo4

时间窗: 6 hrs Vs 24 hrs

次要结局

  • OBJECTIVES: To assess(a) Total time of magnesium sulphate infusion prior to birth)

研究者

发起方
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR SHAHANA SHERIN PP

ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR

研究点 (1)

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