临床试验/NCT06373432

NCT06373432已完成不适用

Intrapartum Glucose Monitoring of GDM: A Randomized Controlled Trial

Icahn School of Medicine at Mount Sinai2 个研究点分布在 1 个国家目标入组 100 人开始时间: 2024年5月1日最近更新: 2025年7月2日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Icahn School of Medicine at Mount Sinai
入组人数: 100
试验地点: 2
主要终点: Neonatal Hypoglycemia

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. The study will be a randomized controlled trial placing patients with Gestational Diabetes Mellitus (GDM) in "frequent" vs "infrequent" glucose monitoring intrapartum and assessing neonatal glucose levels at birth.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Double (Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•All female patients of reproductive age who have the diagnosis GDM
•Patient with singleton gestation presenting in labor or for induction

排除标准

•Patients below the age of 18
•Multiple gestation pregnancy
•Patients undergoing scheduled c-section

结局指标

主要结局

Neonatal Hypoglycemia

时间窗: end of study at 6 months

Glucose values of neonate measured in mg/dL

次要结局

未报告次要终点

研究者

发起方

Icahn School of Medicine at Mount Sinai

申办方类型

Other

责任方

Principal Investigator

主要研究者

Thomas Owens

Principal Investigator

Icahn School of Medicine at Mount Sinai

研究点 (2)

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