跳至主要内容
临床试验/NCT03330951
NCT03330951已完成不适用

Glycemic Control and Iron Status in Diabetic Pregnancies - a Study of New Markers

Helse Stavanger HF1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
Glycemic Control markers in pregnancy

研究概览

简要总结

This is an observational study at the Obstetrical outpatient clinic at Stavanger University Hospital. The main goal is to compare the current marker of glycemic control (glycated hemoglobin A1c, HbA1c) with glycated albumin in pregnancies with pregestational diabetes mellitus.

Women with diabetes are at increased risk for adverse pregnancy outcomes. With improved glycemic control, the risk decreases. Glycated albumin is suggested to be a better marker for monitoring glycemic control in pregnancies because it reflects blood glucose for a shorter period than HbA1c (3 versus 8-12 weeks). Other studies have shown that HbA1c increases in pregnancy because of iron deficiency. The investigators want to investigate HbA1c, glycated albumin and iron status in diabetic pregnancies. The investigators will compare HbA1c and glycated albumin throughout pregnancy with the patient's own blood glucose measurements or data from CGM (continuous blood glucose monitoring). Blood samples for HbA1c and glycated albumin will be taken 6 times during pregnancy (week 12, 20, 24, 28, 32, 36).

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • pregestational diabetes mellitus
  • singleton pregnancy
  • follow-up at Stavanger University Hospital in pregnancy

排除标准

  • gestational diabetes
  • twin pregnancies

结局指标

主要结局

Glycemic Control markers in pregnancy

时间窗: throughout pregnancy, gestational week 12-36.

Compare HbA1c and glycated albumin to blood sugar measurements

次要结局

  • Iron status in diabetic pregnancy,(throughout pregnancy, gestational week 12-36.)
  • Preeclampsia(From gestational week 20 to 1 week after delivery.)
  • Admission to neonatal intensive care unit(At delivery.)
  • Induction of labour(At delivery.)
  • Birth weight(At delivery.)
  • Preterm delivery(at delivery.)
  • APGAR(At delivery.)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验