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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy, Congenital Malformation, Drug Exposure

Intervention / Treatment
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* Drug: chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| drug exposure<br>chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs | Drug: chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs<br>* medication (i.e., chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs ) exposure through the pregnancy life course<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| congenital malformations | Number of births with congenital malformations | up to 42 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preterm birth | Number of pregnancies with preterm birth | up to 37 gestational weeks | 
| low birth weight | Number of live births with low birth weight | Immediately after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cohort study, drug exposures, congenital malformation, pregnancy, population-based