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临床试验/NCT04499066
NCT04499066招募中不适用

Peripartum Mental Health Cohort Study in Guangzhou

Guangzhou Women and Children's Medical Center1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2012年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,000
试验地点
1
主要终点
Change of prevalence of maternal prenatal depression

研究概览

简要总结

The purpose of this study is to determine the incidence,development trajectory and risk factors of the main peripartum mental health problems as well as explore its adverse outcomes.

详细描述

Peripartum mental health problems (such as anxiety and depression), affecting more than 20% of mothers, is one of the most common complications around childbirth and gradually have become global public health issues. However, little is known about the course of peripartum mental health problems and possible fluctuations, as well as related risk factors among Chinese women. In addition, there are no effective prediction and preventive strategies for postpartum depression. The Peripartum Mental Health Cohort Study in Guangzhou will collect the epidemiological, clinical information and biological specimens across pregnancy and childbirth to establish trajectory of peripartum mental health and identify the factors influencing the fluctuations and build a comprehensive prediction model of postpartum depression, as well as explore its adverse outcomes. This study would help to determine the timing of screening and target interventions to improve women's and their offspring's health.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant women with <20 weeks of gestation
  • Pregnant women intended to eventually deliver in Guangzhou Women and Children's Medical Center
  • Permanent residents or families intended to remain in Guangzhou with their child for more than 3 years

排除标准

  • Combined with heart disease, hypertension, diabetes or hyperthyroidism
  • Taking anti-depressants and other treatments for depression
  • Participants was in infection status when the biological samples were collected

结局指标

主要结局

Change of prevalence of maternal prenatal depression

时间窗: before 20th gestational week, after 33th gestational week and prior to delivery

Using Self-rating Depression Scale (SDS) to assess maternal depressive symptoms during pregnancy. SDS scores ≥53 is defined as prenatal depressive symptoms.

Change of prevalence of maternal postpartum depression in the first year after delivery

时间窗: 6 weeks, 6 months and 1 year after delivery

Using Edinburgh Postnatal Depression Scale (EPDS) to assess postpartum depressive symptoms. EPDS scores ≥13 is defined as postpartum depressive symptoms.

次要结局

  • Levels of maternal inflammatory factors during pregnancy(During period of 2-3 trimesters of pregnancy)
  • Level of maternal cortisol during pregnancy(During period of 2-3 trimesters of pregnancy)
  • Child's neurodevelopment at early childhood(At child's age of 1 year)
  • Change of prevalence of maternal anxiety during pregnancy(before 20th gestational week, after 33th gestational week and prior to delivery)
  • Prevalence of preterm birth, small for gestational age, low birth weight(At delivery)

研究者

发起方
Guangzhou Women and Children's Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiu Qiu

Director of the Born in Guangzhou Cohort Study

Guangzhou Women and Children's Medical Center

研究点 (1)

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