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临床试验/NCT03028259
NCT03028259已完成不适用

Does Plasma Glucose Variability in Obese Diabetic Pregnancies Influence Maternal or Neonatal Outcomes?

St. Louis University0 个研究点目标入组 161 人开始时间: 2014年6月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
161
主要终点
glucose levels

研究概览

简要总结

A retrospective data review of 243 pregnant women (≤32 wks gestational age), dtat collected prior to 5/18/2014, with GDM, or T2DM, and their infants (until discharge from the hospital, typically up to 1 week after deliver) will be conducted. These women are of any age and all ethnic backgrounds delivering at St. Mary's Health Center.

详细描述

Maternal glucose control is considered to be a major determinant of neonatal outcome in pregnancies complicated by diabetes. Studies have examined the link between neonatal mortality and morbidity using specific mean preprandial or postprandial plasma glucose levels, however, have not taken into account the daily wide excursions that occur in maternal glucose levels. Limited data are available on glucose variability (GV) in pregnancy and affect on maternal or neonatal outcomes. A recent study amongst diabetics showed that glucose variability between two data points, a morning fasting blood glucose and an afternoon blood glucose, increased the rate of adverse neonatal outcomes1. Glycosylated hemoglobin (A1c), which has been considered the "gold standard" for diabetes control since the Diabetes Control and Complication Trial (DCCT)2, lacks the specificity to predict pregnancy outcomes. Through review of data, we propose to examine other methods of evaluating daily maternal glucose variations to determine the correlation to maternal and neonatal outcomes.

The objective of this study is to determine the effect of glucose variability and/ or other elements on maternal and neonatal outcomes in the obese diabetic patient. We hypothesize that glucose variability will be a stronger indicator of neonatal outcome than A1c or any single given blood glucose value. Glucose variability, including the magnitude of hyperglycemia or the incidence of acute maternal hypo- or hyperglycemic events, will be explored. We hypothesise that obese pregnant women with higher magnitude of glucose fluctuations have more maternal and fetal co morbidities.

研究设计

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

入排标准

年龄范围
14 Years 至 55 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with diabetes in pregnancy of any age, any ethnic background who deliver at St. Mary's Health Center, 1/1/2000 to 5/18/2014.

排除标准

  • Data collected ager 5/18/2014

结局指标

主要结局

glucose levels

时间窗: 1 year

the effect of glucose variability on maternal and neonatal outcomes in the obese diabetic patient.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Vricella, MD

PI

St. Louis University

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