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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04517981
Other study ID # wcqyyzaywqgwyf
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date July 1, 2022

Study information

Verified date August 2020
Source Shanghai Mental Health Center, Jingan District
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Description:

Research objectives

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. 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date July 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

-

Exclusion Criteria:

-

Study Design


Intervention

Behavioral:
Psychological intervention
Choose according to the wishes of the enrolled subjects and the results of the evaluation
Other:
Comprehensive intervention
Choose according to the wishes of the enrolled subjects and the results of the evaluation

Locations

Country Name City State
China Jing'an District Mental Health Center Shanghai Jing'an District

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Mental Health Center, Jingan District

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fate Progression of high-risk pregnant women with perinatal depression in the third trimester 2019.9.1-2022.2.1
Primary Influencing factors Influencing factors of disease progression 2019.9.1-2022.2.1
Primary Impact of intervention The influence of different intervention methods on the course of the disease 2019.9.1-2022.2.1
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