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临床试验/NCT05392231
NCT05392231已完成不适用

Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers Glycated Albumin and Insulin-regulated Aminopeptidase in Women With Gestational Diabetes Mellitus

Haseki Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2022年2月10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
109
试验地点
1
主要终点
Early prediction of gestational diabetes

研究概览

简要总结

The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM).

详细描述

The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM).In this prospective observational study including 109 pregnant women, the fetal pancreas size and maternal serum biomarkers GA and IRAP were measured at the gestational age of 20-22 weeks and later at the gestational age of 24-28 weeks, in 19 participants of them, GDM was confirmed with the 75-g oral glucose tolerance test (OGTT) and the fetal pancreas size was measured in all the participants again.

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 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Maternal age between 18 and 42 years
  • Gestational age between 20 and 28 weeks

排除标准

  • Multiple pregnancies
  • Pregestational diabetes
  • Fetal congenital malformations
  • Placental and amniotic fluid abnormalities
  • Preeclampsia
  • Severe systemic disease
  • Long-term systemic drug usage

结局指标

主要结局

Early prediction of gestational diabetes

时间窗: Two months

Early prediction of gestational diabetes by the fetal pancreas measurement with ultrasound and maternal serum biomarkers glycated albumin and insulin-regulated aminopeptidase measured with ELISA

次要结局

未报告次要终点

研究者

发起方
Haseki Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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