CClinicalTrials.gg
Status unknownNCT04185207ACWPMHSSUpdated Dec 11, 2019

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

An observational study in Mental Disorders During Pregnancy and Mental Disorder in the Puerperium - Baby Delivered, sponsored by Ministry of Science and Technology of the People´s Republic of China. Status unknown. Open to female participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-11.

Sponsored by Ministry of Science and Technology of the People´s Republic of China · Observational

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years to 59 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

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

Keywords

  • Mental health
  • Socioeconomic status
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In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 200 across 480 observational studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Ministry of Science and Technology of the People´s Republic of China is the lead sponsor of 21 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

pregnant women;

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

Exclusion Criteria:

  • Unmarried women; Multiple-pregnancy; Clinical diagnosis of mental disorders before;
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Patient registry
No

Interventions

  • Otherno intervention

    There is no intervention.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

  3. 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.

    Time frame: 1 year

  4. 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.

    Time frame: 1 year

  5. 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.

    Time frame: 1 year

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Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 25446660 ↗
  • 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. PubMed 30068411 ↗
  • 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. PubMed 28299820 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04185207
Lead sponsor
Ministry of Science and Technology of the People´s Republic of China
Collaborators
Gansu Provincial Maternal and Child Health Care Hospital
Responsible party
Hongbo Qi (Director of Obstetric, First Affiliated Hospital of Chongqing Medical University) — Principal investigator
First posted
Dec 4, 2019
Start date
Dec 2019 (estimated)
Primary completion
Nov 2021 (estimated)
Completion
Nov 2021 (estimated)
Last update
Dec 11, 2019

Study contacts

E GONG
Contact
858307510@qq.com
008602389011101
Jianlin ZHAO
study director · First Affiliated Hospital of Chongqing Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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