Survey on the Reproductive and Child-Rearing Situations of Patients With Severe Mental Disorders

Completed

• Conditions: Schizophrenia and Schizoaffective Disorder; Bipolar Disorder (BD)

• Registration Number: NCT07005245
• Lead Sponsor: Peking University

Brief Summary

Severe mental disorders represent a major public health concern, imposing substantial disease burden and adversely affecting multiple dimensions of patients' lives, while also creating intergenerational impacts on their offspring and families. Existing evidence suggests that children of affected patients demonstrate elevated vulnerability to various physical and psychological challenges during developmental stages.

Currently, China lacks systematic data regarding reproductive patterns and child-rearing practices among patients with severe mental disorders. To address this knowledge gap, investigators are conducting a multicenter epidemiological survey across ten representative cities and regions nationwide. This study aims to comprehensively examine the reproductive history, child-rearing circumstances, and family socioeconomic status of this population. The findings will establish a crucial foundation for subsequent analytical epidemiological investigations and intervention studies, while informing evidence-based mental health policy formulation.

The study population consists of registered patients (aged 18-59 years) in the national severe mental disorder management system who meet diagnostic criteria for: schizophrenia, bipolar disorder, paranoid personality disorder, schizoaffective disorder, epilepsy-induced mental disorders, or intellectual disability-associated mental disorders. Eligible participants must have documented childbirth history (including miscarriage, preterm, and term deliveries).

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-06-07
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77145

Inclusion Criteria

• Patients who meet the diagnostic criteria for schizophrenia, bipolar disorder, paranoid personality disorder, schizoaffective disorder, mental disorders caused by epilepsy, or mental disorders associated with intellectual disabilities, and are registered in the management system for severe mental disorders
• Aged 18-60 years
• Patients who had a history of childbirth (childbirth history includes miscarriage, preterm birth, and full-term birth).

Exclusion Criteria

• Do not agree to participate in the survey.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participants' fertility data	Baseline

Secondary Outcome Measures

Name	Time	Method
Somatic/psychiatric morbidity history in participants' offspring	Baseline

Trial Locations

Locations (1)

Peking University Sixth Hospital; 🇨🇳 Beijing, Haidian District, China