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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Congenital Malformation; Drug Exposure
• Intervention / Treatment: Drug: chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs

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 Type: Observational
• Enrollment (Actual): 564760

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361008
      • Xiamen Health and Medical Big Data Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 61 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
drug exposure; chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: West China Hospital
• Collaborators: Xiamen Health Commission; Xiamen Health and Medical Big Data Center
• Investigators: Study Chair: Xin Sun, Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Cohort study; pregnancy; population-based; drug exposures; congenital malformation
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: DEEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Following the policy of Xiamen Health Commission, research institutions could apply for data access by submitting a formal study protocol, subjected to approval by the Xiamen Health and Medical Big Data Center and the Chinese Evidence-based Medicine Center. Ethical review and research registration are mandatory for all studies.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No