Xiamen Registry of Pregnant Women and Offspring (REPRESENT)

NCT ID: NCT04222621

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 761194 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2023-12-31

Brief Summary

To improve the health of women and children under the background of Healthy China 2030, the investigators developed REPRESENT by establishing a pregnancy registry in Xiamen, a sub-provincial city of over four million residents in east China, based on the Maternal and Child Health Management Platform, and then linking to three other platforms, i.e. Residents Healthcare Management Platform, Primary Healthcare Management Platform, and Electronic Healthcare Records (EHR) Platform, which had been developed since 2006. The registry documented information and events about pregnant women from registration at their first trimester to postpartum, and includes the childhood follow up records. The registry not only enables longitudinal follow up of pregnant women and their offspring, but also expands the scope of database from pre-pregnancy exposures to long-term outcomes by data linkage.

During the past 11 years (January 2008 to March 2019), the REPRESENT has accumulated data concerning more than 700 thousands pregnancies. The data volume is substantial with over 800 variables being documented, and most variables are designed as structured fields. The disease categories and codes are standardized according to the International Classification of Diseases 10th Revision (ICD-10). The whole process of data access, data extraction, data processing and data analysis was conducted through an internal-only accessible server at Xiamen Health and Medical Big Data Center. All investigators cannot access sensitive information, are required to sign data confidentiality agreement and should obtain approval by the Xiamen Health and Medical Big Data Center and the Chinese Evidence-based Medicine Center.

Conditions

Pregnant Women; Registries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pregnant women

Pregnant women without intervention

Intervention Type: OTHER

Pregnant women with those exposures of interest determined in specific research based on the registry

Interventions

Pregnant women without intervention

Pregnant women with those exposures of interest determined in specific research based on the registry

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen.

Exclusion Criteria

• None.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xiamen Health and Medical Big Data Center, Xiamen Health Commission

UNKNOWN

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sun Xin

Professor and director of Chinese Evidence-based Medicine Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xin Sun, PhD

Role: STUDY_DIRECTOR

Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University

Other Identifiers

REPRESENT

Identifier Type: -

Identifier Source: org_study_id