Clinical trial NCT05620056: A Population-based Study of Drug Exposures and Adverse Pregnancy Outcomes in China (DEEP)
Official title: A Population-based Study of Drug Exposures and Adverse Pregnancy Outcomes in China (DEEP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Congenital Malformation
Drug Exposure
Keywords: Cohort study
drug exposures
congenital malformation
pregnancy
population-based
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Xiamen Health Commission
name: Xiamen Health and Medical Big Data Center
First posted: 2022-11-17
Enrollment: 564760
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From January 2013, all pregnant women who registered at the Maternal and Child Health Management in Xiamen was included in this cohort.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: congenital malformations
timeFrame: up to 42 days after delivery
Secondary outcomes:
measure: preterm birth
timeFrame: up to 37 gestational weeks
measure: low birth weight
timeFrame: Immediately after delivery
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiamen Health and Medical Big Data Center
state: Fujian
Study officials:
affiliation: Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China
name: Xin Sun
role: STUDY_CHAIR
References: