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临床试验/NCT01875107
NCT01875107撤回4 期

Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients

University of Minnesota1 个研究点 分布在 1 个国家开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Number of hospital days until euglycemia in pregnant diabetic patients receiving steroids who are pre-treated with insulin.

研究概览

简要总结

Our objective is to assess whether pre-treatment with a fixed dose of insulin, based on weight, given to pregnant patients with gestational or preexisting diabetes receiving betamethasone can provide adequate glycemic control.

Our hypothesis is that pre-treatment with a weight-based calculated insulin dose will help maintain euglycemia for pregnant patients with gestational and preexisting diabetes after steroid administration, and possibly impact length of hospital admission.

研究设计

研究类型
Interventional
分配方式
Na
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

  • Pregnant women with gestational or pre-existing diabetes admitted to the University of Minnesota
  • Must be 18 years or older
  • Must speak English, Spanish, or Somali
  • Patients must receive steroids for fetal lung maturity as part of their hospital course

排除标准

  • Pregnant women with Type 1 Diabetes, or Type 2 diabetes with evidence of end-organ disease
  • Pregnant women who need to be emergently delivered due to maternal or fetal complications of pregnancy

研究组 & 干预措施

insulin pre-treatment

Experimental

insulin pre-treatment of pregnant diabetic patients who receive betamethasone

干预措施: insulin pre-treatment (Drug)

结局指标

主要结局

Number of hospital days until euglycemia in pregnant diabetic patients receiving steroids who are pre-treated with insulin.

时间窗: number of hospital days

Pregnant diabetic patients admitted to the hospital who receive steroids for fetal lung maturity will have their blood glucose levels checked before and after receiving steroids. Blood glucose levels will be checked fasting and postprandial until the levels are consistently less than 160. This will vary for patients, but will be on average 2 to 14 days.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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