NCT04517981

Brief Summary

  1. 1.Research and follow-up of the course and outcome of high-risk pregnant women with perinatal depression in the third trimester;
  2. 2.Factors affecting the outcome of the disease;
  3. 3.Recurrence of PND in pregnancy again;
  4. 4.The influence of different intervention methods on the course of the disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

2.4 years

First QC Date

August 14, 2020

Last Update Submit

August 14, 2020

Conditions

Perinatal DepressionPrognosis

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

Drug intervention

Antidepressant

Behavioral: Psychological interventionOther: Comprehensive intervention

Psychological intervention

Cognitive behavior therapy, sand table therapy

Comprehensive intervention

Psychological intervention, community intervention combined with drug intervention

Behavioral: Psychological intervention

Interventions

Psychological interventionBEHAVIORAL

Choose according to the wishes of the enrolled subjects and the results of the evaluation

Comprehensive interventionDrug intervention
Comprehensive interventionOTHER

Choose according to the wishes of the enrolled subjects and the results of the evaluation

Drug intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jing'an District Mental Health Center

Shanghai, Jing'an District, 200436, China

Location

MeSH Terms

Interventions

Psychosocial Intervention

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • huhaiping hp hu

    Superior

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ward Director

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 19, 2020

Study Start

September 1, 2019

Primary Completion

February 1, 2022

Study Completion

July 1, 2022

Last Updated

August 19, 2020

Record last verified: 2020-08

Locations

CN(1)