Treatment approaches for pre eclampsia in low resource settinga
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Primary outcomes- Maternal morbidity–Respiratory depression (<16 respirations per minute)–Respiratory arrest–Pneumonia–Cardiac arrest–Coagulopathy–Renal or liver failure–Pulmonary edema–Cerebral HemorrhageToxicity–Need for calcium gluconate–Stopped or reduced treatment due to toxicity–Stopped or reduced treatment due to side effectsSide Effects–Nausea or vomitting–Flushing of the skin–Drowsiness–Confusion–Muscle weakness–Pain and AbscesssUse of maternal healthcare resources–Number of days in hospital–Admission to intensive care unit (ICU)–Ventilation–Dialysis–Staff timeUse of neonatal resources–Days in special care baby unit–Ventilation
研究概览
简要总结
Magnesium sulphate is the drug of choice for prevention and treating convulsions in severe pre eclampsia and eclampsia1, 2 and though it has been demonstrated to be a safe and effective drug, concerns about the safety of the drug remain. Magnesium sulfate is administered parenterally by IM or IV routes. The IV regimen achieves more stable serum levels of magnesium but requires the use of an infusion pump for safe delivery and has a greater potential for inadvertent overdose. The IM regimen, the standard of care in most hospitals in India, while being potentially more safe, requires repeated painful IM injections. These limitations in administration hinder the widespread use of magnesium sulfate despite its demonstrated benefits.Thus there is urgent need to develop a system of care that avoids overdose and is acceptable to both patients and providers. A safe and simple system for IV administration3 of magnesium sulfate will facilitate the expansion of use into clinical environments where resources do not currently exist to treat with magnesium sulfate prior to delivery or transfer of care. This new technology may also facilitate the broader use magnesium sulfate particularly for women with less severe pre eclampsia who may benefit from prophylactic treatment
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •Exhibit systolic blood pressure > 140mm Hg OR a diastolic pressure > 100 mm Hg Exhibit proteinuria > 1+;Have not given birth, or be 24h or less postpartumExhibit urine output >100 ml or more during the previous 4h or greater than 25 mL/h.Agree to comply with study proceduresBe > 18 years of age Give informed consent for study participation.
排除标准
- •Eclamptic or seizing at the time of enrollmentReceived magnesium sulfate therapy 24h prior to study enrollment.
结局指标
主要结局
Primary outcomes- Maternal morbidity–Respiratory depression (<16 respirations per minute)–Respiratory arrest–Pneumonia–Cardiac arrest–Coagulopathy–Renal or liver failure–Pulmonary edema–Cerebral HemorrhageToxicity–Need for calcium gluconate–Stopped or reduced treatment due to toxicity–Stopped or reduced treatment due to side effectsSide Effects–Nausea or vomitting–Flushing of the skin–Drowsiness–Confusion–Muscle weakness–Pain and AbscesssUse of maternal healthcare resources–Number of days in hospital–Admission to intensive care unit (ICU)–Ventilation–Dialysis–Staff timeUse of neonatal resources–Days in special care baby unit–Ventilation
次要结局
- NA