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临床试验/NCT03726008
NCT03726008终止不适用

The Effect of a Perinatal Health Promotion Program on the Different Levels of Gestational Hyperglycemic Women's Bio-psycho-social Features and Child Growth

Kaohsiung Medical University Chung-Ho Memorial Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年1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
120
试验地点
2
主要终点
Changes of biological indicator

研究概览

简要总结

Taiwan National Health Insurance system was launched in 1995 and the diagnosis and treatment for gestational diabetes mellitus were reimbursed. However, controversy regarding treatment and prevention programs for the other different levels of gestational hyperglycemia continues. Moreover, long-term follow-up studies for the impact of different levels of gestational hyperglycemia on women's perinatal consequences were not found. Thus, the purpose of the study, is to explore the effect of a perinatal health promotion program on three different levels of gestational hyperglycemic women's bio-psycho-social features and their offspring's development.

详细描述

The investigators will recruit 120 women with three different levels of gestational hyperglycemia and assign them to either experimental group (a total of 60 women of gestational hyperglycemia) or control group (a total of 60 women of gestational hyperglycemia). Data will be collected at the women's six-month gestation, hospitalization for childbirth, and six weeks, six months, and one year postpartum. The three-year study findings can demonstrate the consequences and risk factors for women with three different levels of gestational hyperglycemia to suffer from type 2 diabetes mellitus. In addition, the results can be taken as an evidence-based intervention for the perinatal health promotion program in preventing the gestational hyperglycemic women to suffer from type 2 diabetes mellitus and in decreasing the impact of gestational hyperglycemia on the development of the gestational hyperglycemic women's offspring.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • The woman who
  • Is 20 years old or above.
  • Has a positive test for gestational diabetes mellifluous with the 75% oral glucose tolerance test during 24~28 gestation.
  • Has junior high or above educational level.
  • Can speak Mandarin Chinese.
  • Is Taiwanese residence.
  • Plans to give a childbirth at the medical center.

排除标准

  • The woman who
  • Is immigrant.

结局指标

主要结局

Changes of biological indicator

时间窗: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.

Fasting blood glucose test

次要结局

  • Changes of newborn body length(about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.)
  • Changes of maternal height(women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.)
  • Changes of newborn body weight(about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.)
  • Changes of newborn Apgar score(about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.)
  • Changes of maternal body weight(women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.)
  • Changes of newborn head circumference(about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.)
  • Changes of depression(women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.)
  • Changes of diabetes management self-efficacy Scale(women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.)
  • Changes of health status(women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.)
  • Basic information of maternal(women's six-month gestational age)
  • Health information of newborn(about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.)
  • Changes of blood pressure(women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.)
  • Changes of postpartum stress(about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.)
  • Changes of body mass index(women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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