Cohort Study on the Outcome and Influencing Factors of Perinatal Depression

Prognosis Clinical Trial

Official title:

A Cohort Study on the Outcome and Influencing Factors of High-risk Pregnant Women With Perinatal Depression in the Third Trimester

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04517981
• Other study ID #: wcqyyzaywqgwyf
• Status: Enrolling by invitation
• 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
• 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:

-

Related Conditions & MeSH terms

• Asphyxia Neonatorum
• Depression
• Depressive Disorder
• Perinatal Depression
• Prognosis

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