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临床试验/NCT05647798
NCT05647798终止不适用

Management of Intrapartum Glycemia in Gestational Diabetic Mothers: A Randomized Controlled Trial

Inova Health Care Services4 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2023年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
4
主要终点
Initial neonatal glucose post delivery

研究概览

简要总结

This is a randomized, parallel, controlled, non-inferiority trial to assess the impact of a tight versus a more liberalized intrapartum glycemic control in gestational diabetic mothers on neonatal glycemia. National guidelines for the management of intrapartum glucose in women with GDM are lacking. This is likely due to the scarcity of high-quality data on the topic.

详细描述

Gestational diabetes mellitus (GDM) remains a common pregnancy complication, affecting 6-15% of pregnancies worldwide. The incidence of GDM is expected to continue its global upward trend in light of the growing obesity epidemic and delayed childbearing. GDM is associated with adverse short- and long-term maternal and offspring outcomes. Neonatal hypoglycemia, as a result of fetal hyperinsulinemia, occurs in up to 35% of pregnancies complicated by GDM with potential long-term neurodevelopmental sequelae. In that regard, significant emphasis has been placed on the prevention of neonatal hypoglycemia through optimal maternal glycemic control. Available data are conflicting as to the contribution of intrapartum glycemia to neonatal glycemia.

Moreover, national guidelines for the management of intrapartum glucose in women with GDM are lacking. This is likely due to a lack of high-quality data on the topic. As far as we are aware, only one single center randomized controlled trial has been published on the topic. That study's findings suggest that an approach to a more liberalized intrapartum glycemic management was not associated with a higher rate of neonatal hypoglycemia compared to a tight glycemic control regimen. We propose to replicate these findings in a different population at our institution. If this more relaxed approach to intrapartum glycemic management is confirmed to be safe to women and their babies, its clinical application has the potential to decrease the inconvenience of frequent finger pricks for our patients during labor and allow more efficient allocation of resources for the nursing staff on an already labor-intensive unit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • Women 18 years or older
  • Non-anomalous singleton gestation
  • Gestational diabetes type A2 diagnosed at 24 weeks' gestation or beyond
  • Planned vaginal delivery at term at Inova Fairfax Women's Hospital

排除标准

  • Women < 18 years
  • Fetus with major congenital malformations
  • Twin or higher order gestation
  • Pre-existing diabetes mellitus
  • Exposure to antenatal or any systemic steroids 14 days or less prior to delivery
  • Preterm delivery
  • Scheduled cesarean birth
  • Intrapartum cesarean birth prior to 4-5 cm of cervical dilatation

结局指标

主要结局

Initial neonatal glucose post delivery

时间窗: first 2 hours of life

First blood sugar recorded in newborn after delivery

次要结局

  • Mean neonatal glucose within the first 24 hours post-delivery(First 24 hours after delivery)
  • Neonatal intensive care unit length of stay(Birth of newborn until discharge to home or up to 7 days, whichever occurs first)
  • Neonatal jaundice requiring phototherapy(Birth of newborn until discharge to home or up to 7 days, whichever occurs first)
  • Mother's childbirth experience score(Intrapartum)
  • Neonatal hypoglycemia requiring neonatal intensive care unit (NICU)(Birth of newborn until discharge to home or up to 7 days, whichever occurs first)
  • Neonatal hypoglycemia(Birth of newborn until discharge to home or up to 7 days, whichever occurs first)
  • Neonatal intensive care unit admission(Birth of newborn until discharge to home or up to 7 days, whichever occurs first)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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