Peripartum Mental Health Cohort Study in Guangzhou

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Anxiety

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Xiu Qiu, PhD; Phone Number: 0086 20 38367160; Email: qxiu0161@163.com
• Study Contact Backup: Name: Dongmei Wei, MSc; Phone Number: 0086 20 38367159

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510623
      • Recruiting
      • Guangzhou Women And Children's Medical Center
      • Contact: Xiu Qiu, PhD; Email: qxiu0161@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Pregnant women before 20 weeks of gestation

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Levels of maternal inflammatory factors during pregnancy	Using women's blood samples to test the concentration of inflammatory factors, including CRP, IL-6, TNF-α, etc.	During period of 2-3 trimesters of pregnancy
Prevalence of preterm birth, small for gestational age, low birth weight	Obtained from electronic medical records.	At delivery
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

Collaborators and Investigators

• Sponsor: Guangzhou Women and Children's Medical Center
• Investigators: Principal Investigator: Xiu Qiu, PhD, Guangzhou Women And Children's Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2038

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Cohort; Risk factors; Mental health; Pregnancy outcome; Peripartum
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2018053101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No