Clinical trial NCT04517981: Cohort Study on the Outcome and Influencing Factors of Perinatal Depression
Official title: A Cohort Study on the Outcome and Influencing Factors of High-risk Pregnant Women With Perinatal Depression in the Third Trimester
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perinatal Depression
Prognosis
Lead sponsor: Shanghai Mental Health Center, Jingan District
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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;

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
measure: Fate
timeFrame: 2019.9.1-2022.2.1
measure: Influencing factors
timeFrame: 2019.9.1-2022.2.1
measure: Impact of intervention
timeFrame: 2019.9.1-2022.2.1
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Jing'an District Mental Health Center
state: Jing'an District
Study officials:
affiliation: Superior
name: huhaiping hp hu
role: PRINCIPAL_INVESTIGATOR
References: