Peripartum Mental Health Cohort Study in Guangzhou

Recruiting

• Conditions: Depression; Anxiety

• Registration Number: NCT04499066
• Lead Sponsor: Guangzhou Women and Children's Medical Center

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.

Study Timeline

• Study Start: 2012-02-01
• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-30
• Study First Posted: 2020-08-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2025-12-31
• Study Completion: 2038-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of prevalence of maternal prenatal depression	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	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.

Secondary Outcome Measures

Name	Time	Method
Levels of maternal inflammatory factors during pregnancy	During period of 2-3 trimesters of pregnancy	Using women's blood samples to test the concentration of inflammatory factors, including CRP, IL-6, TNF-α, etc.
Level of maternal cortisol during pregnancy	During period of 2-3 trimesters of pregnancy	Using women's blood samples to test the concentration of cortisol.
Child's neurodevelopment at early childhood	At child's age of 1 year	Assessed by using the Gesell Developmental Schedules, which includes adaptive, gross motor, fine motor, language, and social function domains. Higher score in each domain is considered a better outcome, while no more than 85 is defined as suspected development delay.
Change of prevalence of maternal anxiety during pregnancy	before 20th gestational week, after 33th gestational week and prior to delivery	Using Self-rating Anxiety Scale (SAS) to assess maternal anxiety during pregnancy. SAS scores ≥50 is defined as anxiety.
Prevalence of preterm birth, small for gestational age, low birth weight	At delivery	Obtained from electronic medical records.

Trial Locations

Locations (1)

Guangzhou Women and Children's Medical Center; 🇨🇳 Guangzhou, Guangdong, China