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临床试验/NCT05478070
NCT05478070Unknown不适用

The Use of Continuous Glucose Monitors in the Care of Pregnant and Postpartum Women to Limit Frequency of Staff Exposure and Preserve Staff Personal Protective Equipment

Ohio State University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Neonatal outcomes

研究概览

简要总结

Diabetes mellitus (DM) affects roughly 8% of pregnancies and is associated with significant perinatal and maternal morbidity. Current obstetric practice is complicated by the emergence of the SARS-COV-2 pandemic, resulting in morbidity and mortality secondary to complications of COVID-19. Care coordination among the teams caring for women admitted for antepartum, intrapartum, and postpartum care with suspected or confirmed COVID-19 is required to conserve PPE and minimize staff exposure. The investigators propose a pilot proof of concept randomized study to evaluate the utility of Dexcom-G6 continuous glucose monitors for assessment of glycemic control in pregnant and postpartum women with insulin-requiring diabetes mellitus during hospitalizations, as a proof of concept in the efforts to reduce the number of point of care glucose tests needed, reduce staff exposure, and conserve PPE use.

研究设计

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

入排标准

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

入选标准

  • Women aged 18-50 years with a viable singleton or twin intrauterine pregnancy between 8 0/7 and 41 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
  • Diagnosis of pre-gestational or gestational diabetes mellitus A2, admitted to the hospital for labor or other antepartum admissions (besides DKA or glucoregulation)
  • Able to understand the study, and having understood, provide written informed consent in English
  • Infants who survive to hospital discharge who are born to women enrolled in the study

排除标准

  • Participation in another trial that may influence the primary outcome, without prior approval
  • Higher order pregnancy
  • History of severe skin allergy to adhesive products or CGM
  • DKA, admission for glucoregulation
  • COVID-19 PUI or confirmed positive

结局指标

主要结局

Neonatal outcomes

时间窗: 1 year

Outcomes pertaining to overall neonatal health based on incidence of neonatal diseases upon birth as determined by a physical exam of the neonate

Maternal outcomes

时间窗: 1 year

Outcomes pertaining to overall maternal health based on glucose control as determined by HbA1c

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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