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NCT Number: NCT04499066

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Personal Satisfaction Psychological Well-Being

Sex eligibility

Female

Study type

Observational

Primary location

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

Location status: Recruiting

Location contact

Xiu Qiu, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Change of prevalence of maternal prenatal depression

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Change of prevalence of maternal anxiety during pregnancy

    Time frame: 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.

  2. Level of maternal cortisol during pregnancy

    Time frame: During period of 2-3 trimesters of pregnancy

    Using women's blood samples to test the concentration of cortisol.

  3. Levels of maternal inflammatory factors during pregnancy

    Time frame: 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.

  4. Prevalence of preterm birth, small for gestational age, low birth weight

    Time frame: At delivery

    Obtained from electronic medical records.

  5. Child's neurodevelopment at early childhood

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dongmei Wei, MSc

CONTACT

0086 20 38367159

Xiu Qiu, PhD

CONTACT

[email protected]

0086 20 38367160

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2025
Study completion
2038
First posted
Aug 5, 2020
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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