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

• Conditions: Mental Disorders During Pregnancy; Mental Disorder in the Puerperium - Baby Delivered

• Registration Number: NCT04185207
• Lead Sponsor: Ministry of Science and Technology of the People´s Republic of China

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.

Study Timeline

• Study First Submitted: 2019-10-29
• Status Verified: 2019-12
• Study Start: 2019-12
• Study First Submitted QC: 2019-12-01
• Study First Posted: 2019-12-04
• Last Update Submitted: 2019-12-09
• Last Update Posted: 2019-12-11
• Primary Completion: 2021-11
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Income level of perinatal women	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Pregnancy stress	1 year	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.
Pregnancy depression	1 year	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.
Pregnancy somatic symptoms	1 year	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.
Quality of life in pregnancy	1 year	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.
Pregnancy anxiety	1 year	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.