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临床试验/NCT04199676
NCT04199676招募中不适用

Immediate Postpartum Glucose Tolerance Testing Among Gestational Diabetics: A Comparison to the Gold Standard

MemorialCare Health System1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Accuracy of immediate glucose tolerance testing

研究概览

简要总结

The objective of this study is to compare the accuracy of a 2hr glucose tolerance test administered during the postpartum hospitalization with the standard of care glucose tolerance testing (administered at 6 weeks postpartum). The primary hypothesis is that the glucose tolerance test administered in the postpartum period will be accurate and will improve compliance with postpartum testing for gestational diabetics.

详细描述

Gestational diabetes affects approximately 5-10% of pregnancies and its prevalence continues to increase as rates of obesity and metabolic disease increase in reproductive age women. Women diagnosed with gestational diabetes carry an increased risk of developing type 2 diabetes later in life, even if their glucose tolerance initially normalizes following delivery.

The gold standard assessment of glucose tolerance postpartum is a two hour glucose tolerance test (GTT) that is completed between six and twelve weeks' postpartum. Unfortunately, the compliance rate with this test is low, ranging from 30 - 50% by most reports. As a result, a large number of women with glucose intolerance are missed due to noncompliance with postpartum testing, thereby forfeiting the opportunity for diagnosis, treatment and prevention of longterm health consequences. The postpartum hospital stay provides a unique opportunity to increase compliance with glucose tolerance testing due to an increased rate of patient capture. However, it is unknown if administration of a glucose tolerance test in the immediate postpartum period would adequately identify women with persistent glucose intolerance.

The current study aims to provide data towards the accuracy of an immediate postpartum GTT in a population of women with gestational diabetes and provide follow-up data on women with abnormal testing.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 or recently postpartum (postpartum day 0 or 1)
  • ≥ 18 years of age
  • Gestational age ≥34 weeks
  • A1 or A2 gestational diabetes

排除标准

  • Medical exclusion from completing glucose tolerance testing
  • Steroid administration within 10 days prior to enrollment
  • Chronic steroid use

结局指标

主要结局

Accuracy of immediate glucose tolerance testing

时间窗: 6-12 weeks postpartum

Diagnostic accuracy between immediate postpartum glucose tolerance testing and gold standard testing

次要结局

  • Transition to primary care(12 weeks postpartum)
  • Compliance with standard glucose tolerance testing(12 weeks postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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