Study on the Relationship Between Chinese Women's Perinatal Mental Health and Socioeconomic Status (ACWPMHSS)

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.

Study Overview

• Status: Unknown
• Conditions: Mental Disorders During Pregnancy; Mental Disorder in the Puerperium - Baby Delivered
• Intervention / Treatment: Other: no intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

pregnant women;

Description

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;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Income level of perinatal women	A questionnaire investigation on the income in 5 participating hospitals will be conducted. The minimum value is 0 and the maximum value is over than 10000 RMB. It is used to investigate income level.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy stress	This will be measured with Pregnancy Stress Rating Scale. The response options for each item indicate the level of prenatal stress ranging from 0-no stress to 3-severe stress. The results are the average score of all items, and higher scores indicate the higher level, with 0 for no stress, 0.01-1.00 for mild stress, 1.01-2.00 for moderate stress and 2.01-3.00 for severe stress.	1 year
Pregnancy anxiety	This will be measured with the scale of Generalized Anxiety Disorder-7, GAD-7. GAD-7 consisted of seven questions where each question is rated on a scale (0 - 3), three being the maximum. Each subject had a total summed score across all the seven dimensions which range between 0 and 21, a higher score indicates a higher level of anxiety, with 0-4 for no anxiety, 5-9 for mild anxiety, 10-14 for moderate anxiety and 15-21 for severe anxiety.	1 year
Pregnancy depression	This will be measured with the scale of Patient Health Questionnaire-9（PHQ-9）. There are 9 questions in the scale where each question is rated on a scale (0-3), with a high sensitivity and speciality while reaching a cutoff score of 10. Responses are summed to obtain a total score that can range from 0 to 27; scores of 5, 10, 15, and 20 serve as cutoff scores that indicate mild, moderate, moderately severe, and severe depression.	1 year
Pregnancy somatic symptoms	Screening for somatization disorders and assessing the severity of somatic symptoms with the scale of Patient Health Questionnaire-15（PHQ-15）. There are 15 items in the scale where each item is rated on a scale 0(none)-2(massive). Responses are summed to obtain a total score that range from 0 to 30, with 0-4 for no symptom, 5-9 for mild symptom, 10-14 for moderate symptom and 15-30 for severe symptom.	1 year
Quality of life in pregnancy	Perinatal women's quality of life will be measured with the three-level version of European Quality of life five-dimensional scale(EQ-5D-3L). Higher scores mean a worse outcome.	1 year

Collaborators and Investigators

• Sponsor: Ministry of Science and Technology of the People´s Republic of China
• Collaborators: Gansu Provincial Maternity and Child-Care Hospital
• Investigators: Study Director: Jianlin ZHAO, First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2019
• Primary Completion (ANTICIPATED): November 1, 2021
• Study Completion (ANTICIPATED): November 1, 2021

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: December 1, 2019
• First Posted (ACTUAL): December 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Mental health; Socioeconomic status
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Disease; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: Q20191025

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