The Effect of Individualized Exercise Guidance on Pregnancy Outcome: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- macrosomia
研究概览
简要总结
A single center, randomized controlled trial was conducted to investigate whether individualized exercise guidance was more effective in improving pregnancy outcomes in normal pregnant women. What's more, the trial was also conducted to find out whether there is a mediating effect between prenatal exercise and pregnancy outcomes.
详细描述
Fetal macrosomia refers to newborns with a birth weight more than 4000 grams, which poses varying degrees of risks to the health of both mother and infant and also affects the health outcomes of future generations. Research has found that exercise can effectively reduce the incidence of macrosomia and prevent gestational diabetes mellitus, pregnancy-induced hypertension, and excessive weight gain during pregnancy. However, every pregnant woman's individual situation and exercise habits are different, and personalized guidance based on their own circumstances is necessary during pregnancy exercise. The use of intelligent devices for supervision and management is also essential. To explore the impact of personalized exercise guidance during pregnancy on macrosomia, as well as the mediating effect of weight gain during pregnancy on exercise and macrosomia, we conducted a prospective randomized controlled clinical trial. The study included pregnant women who were over 20 years old, married, singleton, in the mid-term of pregnancy, and had no contraindications for exercise during pregnancy. They were randomly divided into an individualized exercise guidance group and standard clinic prenatal care group. Both groups received routine prenatal care and did not have any special dietary recommendations. The pregnant women in the individualized exercise guidance group received regular exercise guidance from a professional teacher and were supervised and managed through a WeChat group. The main outcome indicators were the incidence of macrosomia and the total weight gain during pregnancy.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 45 years.
- •With singleton pregnancy.
- •Second trimester.
- •No contraindications to exercise during pregnancy.
- •Be able to use smart phone for chatting, read and write basic Chinese.
- •Volunteer for research.
排除标准
- •Adverse pregnancy reaction, such as abdominal pain, vaginal bleeding and so on.
结局指标
主要结局
macrosomia
时间窗: From date of enrollment until the date of delivery, assessed up to 28 weeks.
Neonatal birthweight is more than 4000 grams.
gestation weight gain（GWG）
时间窗: From date of enrollment until the date of delivery, assessed up to 28 weeks.
Weight before delivery minus weight before pregnancy.
次要结局
- postpartum weight retention（PPWR）(From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.)
- diastasis recti abdominis（RDA）(From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.)