Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT05620056
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:
NCT05620056
Study Brief:
Protocol Section:
NCT05620056