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临床试验/NCT03748576
NCT03748576已完成不适用

Clinical Research on Mobile Medical Used for the Management of Pregnant Women: a Randomized Control Trail

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 640 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
640
试验地点
1
主要终点
Glycemic qualification rate in women with GDM

研究概览

简要总结

A multicenter, randomized controlled trial was conducted to investigate whether health education and life style management through WeChat group chat was: 1. more effective in improving pregnancy outcomes in normal pregnant women. 2. more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM.

详细描述

  1. Mobile technology and equipment based on Internet and communications technology have revolutionized the content and manner of social interaction and services. Mobile medical care has just started, the relevant platform and service is still immature, not standardized, poor satisfaction, low efficiency, its value and effectiveness of health management lack of clear theoretical support and data description. In this study, based on the multi-center prospective randomized controlled study, we constructed a large-scale maternal health service platform and a systematic standardized maternal health management model to carry out personalized maternal health management and mobile health services. Mobile medical effects validation, and further improve the mobile medical platform.

This study will verify the value of mobile health care for maternal health management, to establish a standardized standard mobile medical model, to further improve the level of domestic maternal health management and improve the quality of maternal and child health management. 2. Most gestational diabetes mellitus (GDM) can be well controlled by health education and life style management, expecting a better pregnancy outcome. But standard clinic prenatal care which consist of clinic visit every two weeks may not give full play to the effects of GDM management. Telemedicine shows its potential to fill this gap. A multicenter, randomized controlled trial was designed to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM. Women with GDM diagnosed by oral glucose tolerance test between 23-30+6 gestational weeks were randomized to a WeChat group chat-based blood glucose management group or routine clinic prenatal care. In PUMCH, investigators also equip CGM for m-health group allowing a more detailed BG information. The primary outcome was change of glycemic qualification rate during follow up period in both groups. The second outcome was pregnancy outcomes. Also, a case control study is designed to compare the glucose control status between rice-richen meal and wheaten-richen meal, and all other macronutrients and micronutrients are all calculated and same between two groups, which may provide more clues for type of carbohydrate recommendation for Chinese women with GDM.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged between 18 and 45 years.
  • With singleton pregnancy
  • Diagnosed or not diagnosed as GDM by 75g oral glucose tolerance test (OGTT) and insulin treatment is not required assessed by multi-disciplinary consultation.
  • Be able to use smart phone for chatting, read and write basic Chinese.
  • Volunteer for research.
  • Exclusion criteria:
  • Pregnancies with diagnosed chronic disease
  • Pregnancies with other pregnancy complications except GDM
  • Pregnancies had recent trauma and treatment of glucocorticoids

排除标准

  • 未提供

结局指标

主要结局

Glycemic qualification rate in women with GDM

时间窗: From enrollment to 42 days postpartum

Glycemic qualification rate was calculated by the number of BG within the control range /30\*100%. BG control range were fasting BG (fasting and before-sleep BG)#95 mg/dL (5.3 mmol/L) and two-hour postprandial BG (post-breakfast, post-lunch, post-dinner BG)#120 mg/dL (6.7 mmol/L)

weight gain during pregnancy

时间窗: up to 40 gestatinal weeks

Participants record their body weight twice a month. Weight gain from third-trimester and the whole pregnancy period are calculated.

次要结局

  • The incidence rate of specific pregnant outcomes in both normal pregnant women and women with GDM(at delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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