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

Completed

• Conditions: Pregnancy; Drug Exposure; Congenital Malformation
• Interventions: Drug: chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs

• Registration Number: NCT05620056
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2021-12-31
• Status Verified: 2022-11
• Study Completion: 2022-11-01
• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-10
• Last Update Submitted: 2022-11-10
• Study First Posted: 2022-11-17
• Last Update Posted: 2022-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 564760

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
drug exposure	chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs	chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs

Primary Outcome Measures

Name	Time	Method
congenital malformations	up to 42 days after delivery	Number of births with congenital malformations

Secondary Outcome Measures

Name	Time	Method
preterm birth	up to 37 gestational weeks	Number of pregnancies with preterm birth
low birth weight	Immediately after delivery	Number of live births with low birth weight

Trial Locations

Locations (1)

Xiamen Health and Medical Big Data Center; 🇨🇳 Xiamen, Fujian, China