Effects of Monitoring Blood Pressure in High-risk Pregnant Women Using a Wearable Device
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Offspring weight change
研究概览
简要总结
In this study, at least 400 women with high-risk of pregnancy hypertension will use a wearable device to monitor the blood pressure during gestational age from 12 weeks to 28weeks. The observed outcomes including maternal and offspring. Participants were from three hospital including Shanghai Xinhua Hospital, Jiaxing Maternal and Child Health Hospital and Peking University Third Hospital. Pregnant women were randomly divided into control group (routine delivery examination group) and intervention group (routine delivery examination group + use of wearable blood pressure monitoring device group), 200 cases each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with a single pregnancy before 12 weeks of pregnancy
- •The presence of any of the following risk factors: age > 30 years, a history of eclampsia, a family history of eclampsia, obesity (BMI ≥ 30 Kg/m2), and a history of gestational hyperglycemia (pregestational type 1 and type 2 diabetes; gestational manifest diabetes and gestational diabetes requiring insulin treatment), preexisting chronic hypertension, kidney disease, and autoimmune diseases such as systemic lupus erythematosus and antiphospholipid syndrome.
- •Signed the informed consent can be continuously followed up.
- •Permanent population living in the study area.
- •All subjects received routine antenatal examination and treatment.
排除标准
- •Termination of pregnancy before 20 weeks
- •Withdraw from the study
- •Lost visitors
结局指标
主要结局
Offspring weight change
时间窗: up to 24 months
The offspring would be followed up from birth to 2 years of age at 42days, 3, 6, 12, 18 and 24 months of birth. Birth weights and weights would be measure in kilograms. The primary outcome the growth curve of the follow-up weights.
次要结局
- Maternal complications(28 weeks)
- Offspring neurodevelopment(up to 24 months)
- Offspring perinatal outcomes(up to 24 months)
- Offspring outcomes(up to 24 months)
- Maternal blood pressure change(16 weeks)