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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05620056
• Other study ID #: DEEP
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2022
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 564760
• Est. completion date: November 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Congenital Abnormalities
• Congenital Malformation
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
China	Xiamen Health and Medical Big Data Center	Xiamen	Fujian

Sponsors (3)

Lead Sponsor	Collaborator
West China Hospital	Xiamen Health and Medical Big Data Center, Xiamen Health Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	congenital malformations	Number of births with congenital malformations	up to 42 days after delivery
Secondary	preterm birth	Number of pregnancies with preterm birth	up to 37 gestational weeks
Secondary	low birth weight	Number of live births with low birth weight	Immediately after delivery