ChiCTR2300068825Not yet recruitingEarly Phase 1
孕期睡眠轨迹对母婴结局影响的多中心前瞻性队列研究
自筹4 sites in 1 countryStarted: July 11, 2022Last updated:
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- Locations
- 4
- Primary Endpoint
- 早产
Study Overview
Brief Summary
研究目的： （1）探索孕期睡眠的纵向变化特征及影响因素 （2）检验孕期睡眠与母婴结局之间的关联 （3）阐述孕期睡眠变化的累积效应及效应发挥的关键期 （4）提出有针对性的孕期睡眠管理策略
Study Design
- Study Type
- 观察性研究
- Primary Purpose
- 队列研究
Eligibility Criteria
- Ages
- 20 to 40 (—)
- Sex
- Female
Inclusion Criteria
- •（1）孕周≤13 周+6 天
- •（4）知情同意并自愿参与
Exclusion Criteria
- •（1）未婚、离异或丧偶者
- •（2）存在严重的躯体或精神疾病
- •（3）研究过程中发生孕（产）妇死亡、流产、死胎、死产或新生儿死亡
- •（4）正在参加其他临床研究的受试者
- •（5）研究人员认为其他原因不适合临床研究者
Arms & Interventions
根据孕期睡眠变化轨迹进行分组
Outcomes
Primary Outcomes
早产
Time Frame: 分娩后
产后抑郁症状
Time Frame: 分娩后一个月、两个月、三个月
Secondary Outcomes
- 婴儿身长(分娩后一个月、两个月、三个月)
- 婴儿体重(分娩后一个月、两个月、三个月)
Investigators
Study Sites (4)
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