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临床试验/NCT01030627
NCT01030627已完成4 期

Treatment Approaches to Preeclampsia

Gynuity Health Projects2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2009年10月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
85
试验地点
2
主要终点
Completion of full course of treatment

研究概览

简要总结

This pilot study will document the efficacy and acceptability of administration of magnesium sulfate with the Springfusor pump for patients and staff at two sites where treatment or preeclampsia with magnesium sulfate is limited or not available. Currently, both sites refer patients to tertiary care facilities for further treatment.

详细描述

Women diagnosed with preeclampsia that the clinic care team deem would benefit from treatment with magnesium sulfate will be given the option of participating in the study. Those who choose to take part in the study and meet study inclusion and exclusion criteria will receive full information about the study and be required to give their written or signed informed consent.

Women agreeing to participate in the study will receive a loading dose and maintenance therapy using an IV infusion administered by the Springfusor® pump. Women will receive a 8 mL loading dose containing 4g magnesium sulfate heptahydrate (MgSO4*7H2O) 50% solution, which is approximately 2 mmoL magnesium/mL. The loading dose of 8mL with 4 g MgSO4 will be administered using the Springfusor® pump. The administration of the loading dose will be immediately followed by a maintenance infusion. The maintenance dose of 4 g (8 cc, 50% MgSO4) will be administered with the Springfusor® pump continuously over four hours. Clinical monitoring will occur once every hour during the treatment period. Clinical monitoring will occur throughout the treatment, with reflexes, urine output and respiration to be checked at least every hour (or, if more frequent, as per standard practice at the study site). The pump will be checked at each monitoring visit. Prior to discharge from the study, patients will be asked to assess their opinions about the acceptability and ease of use of the mode of administration. All requests or inquiries about termination of treatment will be recorded.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
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

Completion of full course of treatment

时间窗: 24 hours

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 (2)

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