A Population-based Study of Drug Exposures and Adverse Pregnancy Outcomes in China (DEEP)

NCT ID: NCT05620056

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 564760 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2022-11-01

Brief Summary

The DEEP cohort is the first population-based cohort of pregnant population in China that longitudinally documents drug uses throughout the pregnancy life course and adverse pregnancy outcomes.

Detailed Description

The DEEP cohort is the first population-based cohort of pregnant population in China that longitudinally documents drug uses throughout the pregnancy life course and adverse pregnancy outcomes. The main goal of the study aims to monitor and evaluate the safety of drug use through the pregnancy life course in the Chinese setting. The DEEP cohort is developed primarily based on the population-based data platforms in Xiamen, a municipal city of 5 million population in southeast China. Based on these data platforms, a pregnancy-centered registry was developed that documented health care services and outcomes in the maternal and other departments. For identifying drug uses, a drug prescription database was specifically developed by using electronic healthcare records documented in the platforms across the primary, secondary and tertiary hospitals. By linking the pregnancy registry and prescription database through a unique identifier, the DEEP cohort was developed. All the pregnant women and their offspring in Xiamen are provided with health care and followed up according to standard protocols in the region, including antenatal care, delivery care, postpartum follow-up and childhood follow-ups. The primary adverse outcomes - congenital malformations - are collected using a standardized Case Report Form.

Conditions

Pregnancy; Congenital Malformation; Drug Exposure

Study Design

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

Study Groups

drug exposure

chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs

chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs

Intervention Type: DRUG

medication (i.e., chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs ) exposure through the pregnancy life course

Interventions

chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs

medication (i.e., chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs ) exposure through the pregnancy life course

Intervention Type: DRUG

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 Commission

UNKNOWN

Sponsor Role: collaborator

Xiamen Health and Medical Big Data Center

UNKNOWN

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sun Xin

Director of Chinese Evidence-based Medicine Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xin Sun

Role: STUDY_CHAIR

Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China

Locations

Xiamen Health and Medical Big Data Center

Xiamen, Fujian, China

Countries

China

Other Identifiers

DEEP

Identifier Type: -

Identifier Source: org_study_id