Clinical trial NCT04185207: Study on the Relationship Between Chinese Women's Perinatal Mental Health and Socioeconomic Status
Official title: Study on the Relationship Between Chinese Women's Perinatal Mental Health and Socioeconomic Status
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Disorders During Pregnancy
Mental Disorder in the Puerperium - Baby Delivered
Keywords: Mental health
Socioeconomic status
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
Collaborators: name: Gansu Provincial Maternal and Child Health Care Hospital
First posted: 2019-12-04
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women;

Brief summary: The objective of this study is to explore the relationship between perinatal women's mental health and socioeconomic status, observe the perinal outcomes of different income level, and make mental health reference value for them. Questionaires will be used to investigate women's income and mental health status in 4 periods, including the first, second, third trimester and postpartum 42 days. After delivery, birth outcomes will be collected from participating hospitals' clinical case system. All data will be analysed with statistical software.

Detailed description: The objective of this study is to explore the relationship between perinatal women's mental health and socioeconomic status, observe the perinal outcomes of different income level, and make mental health reference value for them. Several hospitals from 5 provinces located in the est, west, south, north and middle of China will participate in the study which plans to include 5000 pregnant women. Questionaire will be used to investigate women's income and mental health status in 4 periods, including the first, second, third trimester and postpartum 42 days. After delivery, birth outcomes will be collected from participating hospitals' clinical case system. All data will be analysed with statistical software.

Eligibility criteria: Inclusion Criteria:

* Must be able to read and understand informed consent; Age 18-59; Singleton in 12-14 gestational weeks; Plan to give bith in participating hospital; Must be able to comply with study regulations;

Exclusion Criteria:

* Unmarried women; Multiple-pregnancy; Clinical diagnosis of mental disorders before;

Primary outcomes:
measure: Income level of perinatal women
timeFrame: 1 year
Secondary outcomes:
measure: Pregnancy stress
timeFrame: 1 year
measure: Pregnancy anxiety
timeFrame: 1 year
measure: Pregnancy depression
timeFrame: 1 year
measure: Pregnancy somatic symptoms
timeFrame: 1 year
measure: Quality of life in pregnancy
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Jianlin ZHAO
role: STUDY_DIRECTOR
References:
citation: Mei-Dan E, Ray JG, Vigod SN. Perinatal outcomes among women with bipolar disorder: a population-based cohort study. Am J Obstet Gynecol. 2015 Mar;212(3):367.e1-8. doi: 10.1016/j.ajog.2014.10.020. Epub 2014 Oct 15.
citation: Glover V, O'Donnell KJ, O'Connor TG, Fisher J. Prenatal maternal stress, fetal programming, and mechanisms underlying later psychopathology-A global perspective. Dev Psychopathol. 2018 Aug;30(3):843-854. doi: 10.1017/S095457941800038X.
citation: Rocheleau CM, Bertke SJ, Lawson CC, Romitti PA, Desrosiers TA, Agopian AJ, Bell E, Gilboa SM; National Birth Defects Prevention Study. Factors associated with employment status before and during pregnancy: Implications for studies of pregnancy outcomes. Am J Ind Med. 2017 Apr;60(4):329-341. doi: 10.1002/ajim.22700.