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Mental Disorders During PregnancyACWPMHSSNCT04185207

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

An observational study of Mental Disorders During Pregnancy and Mental Disorder in the Puerperium - Baby Delivered, run by Ministry of Science and Technology of the People´s Republic of China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 59 years, women onlyHealthy volunteers can take part
How many people
5,000 participants
Where
No sites listed yet
Study dates
Dec 2019to Nov 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: pregnant women;

Who may be able to join

  • 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;

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

E GONG contact

008602389011101

858307510@qq.com

About this study

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.

Being tested
no intervention
Keywords
Mental health, Socioeconomic status
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no interventionOther

    There is no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (5)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2019
  2. Study startDec 2019 (estimated)
  3. Primary completionNov 2021 (estimated)
  4. Study completionNov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04185207
Sponsor's protocol ID
Q20191025
Acronym
ACWPMHSS
Status last verified
Dec 2019
First submitted
29 Oct 2019
Last updated
11 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Disorders During Pregnancy and Mental Disorder in the Puerperium - Baby Delivered, run by Ministry of Science and Technology of the People´s Republic of China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact E GONG (008602389011101, 858307510@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Income level of perinatal women (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04185207, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.

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