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临床试验/NCT02838875
NCT02838875Unknown3 期

To Examine if the Mother's Glucose Levels and Glucose Levels in the Blood Can Predict Cord Hypoglycemia in Newborns at Risk.

Tel-Aviv Sourasky Medical Center0 个研究点目标入组 1,000 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
3 期
入组人数
1,000
主要终点
Cord blood glucose levels as a predictor to newborns Hypoglycemia

研究概览

简要总结

Background Neonatal hypoglycemia is one of the most common metabolic disorders in neonatology. Maintaining stable levels of glucose in the transition from fetal life to life after birth is very important. Yet, except for the recognizing of at-risk populations, there are not many individual measures which can help and predict which newborns (from at-risk populations) will develop hypoglycemia and which will not.

OBJECTIVE our objective is to try to characterize by the mother's glucose levels at birth and by umbilical cord glucose levels who would be at increased risk of hypoglycemia in the hours after birth in the population that is at increased risk of this complication in advance.

详细描述

Background Neonatal hypoglycemia is one of the most common metabolic disorders in neonatology. Maintaining stable levels of glucose in the transition from fetal life to life after birth is very important. Yet, except for the recognizing of at-risk populations, there are not many individual measures which can help and predict which newborns (from at-risk populations) will develop hypoglycemia and which will not.

OBJECTIVE our objective is to try to characterize by the mother's glucose levels at birth and by umbilical cord glucose levels who would be at increased risk of hypoglycemia in the hours after birth in the population that is at increased risk of this complication in advance.

PATIENTS & METHODS All women who arrived to the delivery room at Lis hospital and which the newborn is about to undergo glucose levels follow-up after birth regardless the study, because his affiliation to the at-risk population including: delivery below 37th week, maternal diabetes during pregnancy and newborns in weight under percentile 10 or above percentile 90 by Dolberg graphs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Single pregnancy
  • Vaginal or cesarean birth.
  • Births where there is an indication of neonatal hypoglycemia follow-up - one or more of the following:
  • Delivery week below 37 full weeks.
  • Maternal diabetes during pregnancy (gestational diabetes or pre-gestational).
  • Newborn under percentile 10 by Dolberg graph.
  • Newborn above percentile 90 by Dolberg graph.

排除标准

  • Multiple Pregnancy
  • pregnancies in which there is no indication for routine monitoring of glucose levels after birth

结局指标

主要结局

Cord blood glucose levels as a predictor to newborns Hypoglycemia

时间窗: 2 weeks

Taking blood samples as a predictor to number of Hypoglycemic children.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

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