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

S

Sichuan University

Status

Completed

Conditions

Drug Exposure
Congenital Malformation
Pregnancy

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

564,760 patients

Sex

Female

Ages

14 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • None

Trial design

564,760 participants in 1 patient group

drug exposure
Description:
chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs
Treatment:
Drug: chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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