Perinatal DepressionNCT04517981
Cohort Study on the Outcome and Influencing Factors of Perinatal Depression
An observational study of Perinatal Depression and Prognosis, run by Shanghai Mental Health Center, Jingan District at 1 site in China.
Trial summary
1. Research and follow-up of the course and outcome of high-risk pregnant women with perinatal depression in the third trimester; 2. Factors affecting the outcome of the disease; 3. Recurrence of PND in pregnancy again; 4. The influence of different intervention methods on the course of the disease. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Perinatal Depression, Prognosis
- What is being tested?
- Psychological intervention and Comprehensive intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Jul 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. Pregnant women in the third trimester (after 32 weeks of gestation); 2. Shanghai resident pregnant women (for follow-up after delivery); 3. Be able to complete perinatal care and infant health checkups in the research hospital; 4. Decide to give birth in the research hospital; 5. Willing to participate in this research and sign an informed consent form;
Who may be able to join
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Jing'an District Mental Health Center
Shanghai, Jing'an District, 200436
About this study
Official title: A Cohort Study on the Outcome and Influencing Factors of High-risk Pregnant Women With Perinatal Depression in the Third Trimester
- Research and follow-up of the course and outcome of high-risk pregnant women with perinatal depression in the third trimester;
- Factors affecting the outcome of the disease;
- Recurrence of PND in pregnancy again;
- The influence of different intervention methods on the course of the disease.
Read the detailed description
Research objectives
- Research and follow-up of the course and outcome of high-risk pregnant women with perinatal depression in the third trimester;
- Factors affecting the outcome of the disease;
- Recurrence of PND in pregnancy again;
- The influence of different intervention methods on the course of the disease. Research process: 1. The pregnant women who were filed at Xinhua Hospital and Tongji Hospital and were receiving perinatal care from July 2019 to December 2019 were evaluated in the third trimester of pregnancy using the General Situation Questionnaire, SSRS, PHQ-9, and GAD-7. Those with PHQ-9 score ≥ 5 or GAD ≥ 5 were classified as having symptoms of depression and anxiety, and those who were screened positive were included in the study cohort; 42 days postpartum, 3 months postpartum, 6 months postpartum, 12 months postpartum, 18 months postpartum , 24 months postpartum, use PHQ-9, GAD-7 scale, 6 quality of life questionnaires, and SSRS to evaluate the cohort. If the PHQ-9 score is greater than or equal to 5 or the GAD is greater than or equal to 5, the psychiatrist will perform a clinical examination based on DSM-IV to make a clinical diagnosis; the outcome of the cohort and the incidence and influencing factors; 2 . During the follow-up process, the cohort developed high-risk pregnant women with depression, anxiety symptoms and other perinatal depressive disorders during the follow-up process. Based on the WeChat platform, integrated general hospitals, psychological counseling centers, social families and other service resources were carried out throughout the prenatal and first delivery period. Intervention methods such as community intervention for perinatal depression that focus on the comprehensive "physiology, psychology, and society" of the whole process after the first childbirth. Pregnant women diagnosed with PND will be evaluated by a psychiatrist to determine the treatment plan, and follow-up will continue.
- Conditions
- Perinatal Depression, Prognosis
- Being tested
- Psychological intervention, Comprehensive intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological interventionBehavioural
Choose according to the wishes of the enrolled subjects and the results of the evaluation
Comprehensive interventionOther
Choose according to the wishes of the enrolled subjects and the results of the evaluation
| Study group | Role | What they receive |
|---|---|---|
| Drug intervention | Antidepressant Receives: Behavioral: Psychological intervention; Other: Comprehensive intervention | |
| Psychological intervention | Cognitive behavior therapy, sand table therapy | |
| Comprehensive intervention | Psychological intervention, community intervention combined with drug intervention Receives: Behavioral: Psychological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fate
Progression of high-risk pregnant women with perinatal depression in the third trimester
Measured: 2019.9.1-2022.2.1
Influencing factors
Influencing factors of disease progression
Measured: 2019.9.1-2022.2.1
Impact of intervention
The influence of different intervention methods on the course of the disease
Measured: 2019.9.1-2022.2.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Sep 2019
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center, Jingan District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiping Hu, Shanghai Mental Health Center, Jingan District
- Investigators
- huhaiping hp hu, Principal investigator, Superior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517981
- Sponsor's protocol ID
- wcqyyzaywqgwyf
- Status last verified
- Aug 2020
- First submitted
- 14 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on the Outcome and Influencing Factors of High-risk Pregnant Women With Perinatal Depression in the Third Trimester
- ClinicalTrials.gov ID
- NCT04517981
- Acronym / sponsor ID
- wcqyyzaywqgwyf
- Conditions
- Perinatal Depression, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Mental Health Center, Jingan DistrictUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Research and follow-up of the course and outcome of high-risk pregnant women with perinatal depression in the third trimester;
- Factors affecting the outcome of the disease;
- Recurrence of PND in pregnancy again;
- The influence of different intervention methods on the course of the disease.
Detailed description
Research objectives
- Research and follow-up of the course and outcome of high-risk pregnant women with perinatal depression in the third trimester;
- Factors affecting the outcome of the disease;
- Recurrence of PND in pregnancy again;
- The influence of different intervention methods on the course of the disease. Research process: 1. The pregnant women who were filed at Xinhua Hospital and Tongji Hospital and were receiving perinatal care from July 2019 to December 2019 were evaluated in the third trimester of pregnancy using the General Situation Questionnaire, SSRS, PHQ-9, and GAD-7. Those with PHQ-9 score ≥ 5 or GAD ≥ 5 were classified as having symptoms of depression and anxiety, and those who were screened positive were included in the study cohort; 42 days postpartum, 3 months postpartum, 6 months postpartum, 12 months postpartum, 18 months postpartum , 24 months postpartum, use PHQ-9, GAD-7 scale, 6 quality of life questionnaires, and SSRS to evaluate the cohort. If the PHQ-9 score is greater than or equal to 5 or the GAD is greater than or equal to 5, the psychiatrist will perform a clinical examination based on DSM-IV to make a clinical diagnosis; the outcome of the cohort and the incidence and influencing factors; 2 . During the follow-up process, the cohort developed high-risk pregnant women with depression, anxiety symptoms and other perinatal depressive disorders during the follow-up process. Based on the WeChat platform, integrated general hospitals, psychological counseling centers, social families and other service resources were carried out throughout the prenatal and first delivery period. Intervention methods such as community intervention for perinatal depression that focus on the comprehensive "physiology, psychology, and society" of the whole process after the first childbirth. Pregnant women diagnosed with PND will be evaluated by a psychiatrist to determine the treatment plan, and follow-up will continue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drug intervention | – | Behavioral: Psychological intervention, Other: Comprehensive interventionAntidepressant |
| Psychological intervention | – | –Cognitive behavior therapy, sand table therapy |
| Comprehensive intervention | – | Behavioral: Psychological interventionPsychological intervention, community intervention combined with drug intervention |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Pregnant women in the third trimester (after 32 weeks of gestation); 2. Shanghai resident pregnant women (for follow-up after delivery); 3. Be able to complete perinatal care and infant health checkups in the research hospital; 4. Decide to give birth in the research hospital; 5. Willing to participate in this research and sign an informed consent form;
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological interventionChoose according to the wishes of the enrolled subjects and the results of the evaluation | Behavioural | Comprehensive intervention, Drug intervention |
| Comprehensive interventionChoose according to the wishes of the enrolled subjects and the results of the evaluation | Other | Drug intervention |
Primary outcome
Fate
Time frame: 2019.9.1-2022.2.1
Progression of high-risk pregnant women with perinatal depression in the third trimester
Influencing factors
Time frame: 2019.9.1-2022.2.1
Influencing factors of disease progression
Impact of intervention
Time frame: 2019.9.1-2022.2.1
The influence of different intervention methods on the course of the disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
huhaiping hp hu principal investigator
Superior
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Depression and Prognosis, run by Shanghai Mental Health Center, Jingan District at 1 site in 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 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fate (time frame: 2019.9.1-2022.2.1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2020.