NCT05620056

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 564,760 (actual)
• Sponsor: West China Hospital · Academic / Other
• Sex: Female
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2013-01-01
• Primary completion: 2021-12-31
• Completion: 2022-11-01
• First posted: 2022-11-17
• Last updated: 2022-11-17

Locations

1 site across 1 country: China