Peripartum Mental Health Cohort Study in Guangzhou

Depression Clinical Trial

Official title:

Peripartum Mental Health Cohort Study in Guangzhou

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04499066
• Other study ID #: 2018053101
• Status: Recruiting
• Start date: February 1, 2012
• Est. completion date: December 31, 2038

Study information

• Verified date: September 2023
• Source: Guangzhou Women and Children's Medical Center
• Contact: Xiu Qiu, PhD
• Phone: 0086 20 38367160
• Email: qxiu0161[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2038
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression

Locations

Country	Name	City	State
China	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of prevalence of maternal prenatal depression	Using Self-rating Depression Scale (SDS) to assess maternal depressive symptoms during pregnancy. SDS scores =53 is defined as prenatal depressive symptoms.	before 20th gestational week, after 33th gestational week and prior to delivery
Primary	Change of prevalence of maternal postpartum depression in the first year after delivery	Using Edinburgh Postnatal Depression Scale (EPDS) to assess postpartum depressive symptoms. EPDS scores =13 is defined as postpartum depressive symptoms.	6 weeks, 6 months and 1 year after delivery
Secondary	Change of prevalence of maternal anxiety during pregnancy	Using Self-rating Anxiety Scale (SAS) to assess maternal anxiety during pregnancy. SAS scores =50 is defined as anxiety.	before 20th gestational week, after 33th gestational week and prior to delivery
Secondary	Level of maternal cortisol during pregnancy	Using women's blood samples to test the concentration of cortisol.	During period of 2-3 trimesters of pregnancy
Secondary	Levels of maternal inflammatory factors during pregnancy	Using women's blood samples to test the concentration of inflammatory factors, including CRP, IL-6, TNF-a, etc.	During period of 2-3 trimesters of pregnancy
Secondary	Prevalence of preterm birth, small for gestational age, low birth weight	Obtained from electronic medical records.	At delivery
Secondary	Child's neurodevelopment at early childhood	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.	At child's age of 1 year