Cohort Study on the Outcome and Influencing Factors of Perinatal Depression

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

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.

Study Overview

• Status: Unknown
• Conditions: Prognosis; Perinatal Depression
• Intervention / Treatment: Behavioral: Psychological intervention; Other: Comprehensive intervention

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Jing'an District
    • Shanghai, Jing'an District, China, 200436
      • Jing'an District Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

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;

Description

Inclusion Criteria:

-

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Drug intervention; Antidepressant	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
Psychological intervention; Cognitive behavior therapy, sand table therapy
Comprehensive intervention; Psychological intervention, community intervention combined with drug intervention	Behavioral: Psychological intervention; Choose according to the wishes of the enrolled subjects and the results of the evaluation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center, Jingan District
• Investigators: Principal Investigator: huhaiping hp hu, Superior

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Infant, Newborn, Diseases; Depression; Depressive Disorder; Asphyxia Neonatorum
• Other Study ID Numbers: wcqyyzaywqgwyf

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No