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临床试验/NCT04278664
NCT04278664终止不适用

Effect of Telemedicine on Outcomes in Pregnant Women With Type 1 Diabetes Mellitus

Ana Braescu0 个研究点目标入组 5 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
5
主要终点
HbA1c, maternal glycemic control

研究概览

简要总结

Hypothesize that co-managing pregnant type 1 diabetics with telemedicine will have at least equivalent outcomes to those managed with standard care. Comparison of outcomes between pregnant type 1 diabetics being co-managed with telemedicine compared to those receiving conventional care will help identify unanswered clinical questions and areas for improvement in regard to standards of care for pregnant type 1 diabetics. The data generated from this analysis will help determine whether telemedicine can be an effective additional means of care for pregnant type 1 diabetic patients.

详细描述

Few studies have researched the use of telemedicine in the management of type 1 diabetes during pregnancy. These studies are additionally limited due to the number of patients as well as several secondary outcomes reported. Therefore, this study will enroll 100 participants to reach a power of 81.8% with HbA1c as a primary outcome and secondary outcomes related to diabetic management such as frequency of hypoglycemia, antenatal hospital stay (percentage requiring admission, length of stay), miscarriage, cesarean section rates, induction of labor, fetal birth weight, gestational age at birth or preterm birth (<34 weeks, <37 weeks), frequency of neonatal hypoglycemia, shoulder dystocia, neonatal death, major and minor anomalies, and neonatal intensive care admission.

研究设计

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

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

  • type 1 diabetics who are at or less than 16 weeks in their pregnancy
  • 18 years of age or more
  • Voluntary participation

排除标准

  • <18 years of age
  • Not Type I diabetic

结局指标

主要结局

HbA1c, maternal glycemic control

时间窗: first trimester in pregnancy through 6 weeks postpartum

maternal glycemic control during pregnancy as measured by HbA1c

次要结局

未报告次要终点

研究者

发起方
Ana Braescu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ana Braescu

Research Coordinator

Pediatrix

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