Clinical trial NCT04499066: Peripartum Mental Health Cohort Study in Guangzhou
Official title: Peripartum Mental Health Cohort Study in Guangzhou
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depression
Anxiety
Keywords: Peripartum
Mental health
Risk factors
Pregnancy outcome
Cohort
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 3000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women before 20 weeks of gestation

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change of prevalence of maternal prenatal depression
timeFrame: before 20th gestational week, after 33th gestational week and prior to delivery
measure: Change of prevalence of maternal postpartum depression in the first year after delivery
timeFrame: 6 weeks, 6 months and 1 year after delivery
Secondary outcomes:
measure: Change of prevalence of maternal anxiety during pregnancy
timeFrame: before 20th gestational week, after 33th gestational week and prior to delivery
measure: Level of maternal cortisol during pregnancy
timeFrame: During period of 2-3 trimesters of pregnancy
measure: Levels of maternal inflammatory factors during pregnancy
timeFrame: During period of 2-3 trimesters of pregnancy
measure: Prevalence of preterm birth, small for gestational age, low birth weight
timeFrame: At delivery
measure: Child's neurodevelopment at early childhood
timeFrame: At child's age of 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
Study officials:
affiliation: Guangzhou Women and Children's Medical Center
name: Xiu Qiu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20.