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临床试验/NCT00666133
NCT00666133已完成不适用

Treatment Approaches for Preeclampsia in Low-Resource Settings

Gynuity Health Projects4 个研究点 分布在 1 个国家目标入组 304 人开始时间: 2008年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
304
试验地点
4
主要终点
completed course of treatment

研究概览

简要总结

Preeclampsia is a condition unique to pregnancy characterized by the new onset of hypertension and proteinuria. Eclampsia, characterized by maternal seizures, is a serious complication increasing the risk of maternal and infant mortality and morbidity. Magnesium sulfate is the drug of choice for prevention and treating convulsions in severe preeclampsia and eclampsia.

Magnesium sulfate is administered parenterally by intramuscular (IM) or intravenous routes (IV). In general a loading dose of 4 to 5 grams of magnesium sulfate is administered intravenously followed by an IM injection every 4 hours or by a continuous IV infusion. 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. Although magnesium sulfate has been demonstrated as a safe and effective drug for the treatment and prevention of severe preeclampsia and eclampsia, concerns about the safety of the drug remain. The IM dosing regimen, while potentially safer, requires repeated painful IM injections. These limitations in administration hinder the widespread use of magnesium sulfate despite its demonstrated benefits.

The goal of this research is to develop a system of care that avoids overdose and facilitates the use of magnesium sulfate for the treatment of preeclampsia. To this end, a primary objective of this research is to demonstrate the safety of a simple, inexpensive flow controlled pump system (Springfusor®). This randomized study will compare the administration of magnesium sulfate by the Springfusor® controlled pump with an IM regimen, the standard of care in most hospitals in India. The study will document the efficacy and acceptability of each treatment for patients and staff and compare the cost and time elements involved in providing each method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

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

completed course of treatment

时间窗: 24 hours postpartum

次要结局

未报告次要终点

研究者

发起方
Gynuity Health Projects
申办方类型
Other

研究点 (4)

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