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

Mental Disorders During Pregnancy Clinical Trial

— ACWPMHSS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04185207
• Other study ID #: Q20191025
• Status: Not yet recruiting
• Start date: December 2019
• Est. completion date: November 2021

Study information

• Verified date: December 2019
• Source: Ministry of Science and Technology of the People´s Republic of China
• Contact: E GONG
• Phone: 008602389011101
• Email: 858307510[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 59 Years

Eligibility

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;

Related Conditions & MeSH terms

• Disease
• Mental Disorder in the Puerperium - Baby Delivered
• Mental Disorders
• Mental Disorders During Pregnancy
• Psychotic Disorders

Intervention

Other:
• no intervention
There is no intervention.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Science and Technology of the People´s Republic of China	Gansu Provincial Maternity and Child-Care Hospital

References & Publications (3)

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. — View 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. — View 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. A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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