Sleep Trajectories Among Pregnant Women and Its Impact on Maternal and Infant Outcomes: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Postpartum depression symptoms at 2 months after delivery
研究概览
简要总结
The goal of this observational study is to: 1) determine the prevalence of sleep disorders in pregnancy and the early postpartum; 2) identify factors associated with sleep disturbance during pregnancy and the early postpartum; 3) describe the progression of sleep quality and quantity as gestational age; 4) determine if sleep is associated with adverse perinatal outcomes. Participants were asked to wear a forehead sleep recorder for 4 consecutive days and to complete a sleep questionnaire at ten timepoints: at 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, and 9 months pregnant and at 1 month, 2 months and 3 months postpartum.
详细描述
There is a high incidence of sleep disturbances globally, especially among pregnant women. Long-term sleep disorders seriously affect the quality life of individuals, and it becomes undoubtedly an important public health problem. Studies have shown that sleep disorders during pregnancy can have short-term and long-term adverse effects on both mothers and their babies. In addition, sleep during pregnancy exhibits different characteristics at different stages. Most of the existing studies are based on the overall development trend to study sleep characteristics, ignoring potential individual differences. Based on the concept of precision medicine, this study intends to establish a cohort focusing on the sleep health of pregnant women, and carry out continuous home sleep monitoring of pregnant women from both subjective and objective perspectives. The aim of this study is, firstly, to explore the longitudinal change characteristics, potential classification and influencing factors of sleep during pregnancy; secondly, to analyze the differences in maternal and infant adverse outcomes among pregnant women with different sleep development trajectories. The final goal is to reveal the exposure window of maternal and infant adverse outcomes caused by sleep, thus improving the accuracy of outcome prediction, and promoting the development of accurate and personalized sleep management programs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestation age ≤ 13 weeks + 6 days
- •20 years old ≤ Age ≤ 40 years old
- •Singleton pregnancy
- •Give informed consent and able to participated
排除标准
- •Unmarried, divorced or widowed
- •Women who suffered severe physical or mental illness
- •Women who suffered death, abortion, stillbirth or neonatal death during the study
- •Women who are participating in other studies
- •Other reasons
结局指标
主要结局
Postpartum depression symptoms at 2 months after delivery
时间窗: 2 months after delivery
Postpartum depression symptoms at 2 months after delivery will be measured by the Edinburgh postpartum depression scale (EPDS).
Postpartum depression symptoms at 3 months after delivery
时间窗: 3 months after delivery
Postpartum depression symptoms at 3 months after delivery will be measured by the Edinburgh postpartum depression scale (EPDS).
Caesarean section
时间窗: delivery
Caesarean section refers to a baby delivered through an incision in the mother's abdomen. It will be identified according to the medical history records.
Preterm birth
时间窗: delivery
Preterm birth refers to a body born before 37 weeks of gestation. It will be identified according to the medical history records.
Postpartum depression symptoms at 1 month after delivery
时间窗: 1 month after delivery
Postpartum depression symptoms at 1 month after delivery will be measured by the Edinburgh postpartum depression scale (EPDS).
次要结局
- Infant's length(delivey)
- 1-minute Apgar score(1 minute after delivey)
- 5-minute Apgar score(5 minutes after delivey)
- Infant's weight(delivey)