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Completed

NCT Number: NCT05620056

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.

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Key information

Age range

14 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Xiamen Health and Medical Big Data Center

Xiamen, Fujian, 361008, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs

Drug

medication (i.e., chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs ) exposure through the pregnancy life course

Primary outcomes

  1. congenital malformations

    Time frame: up to 42 days after delivery

    Number of births with congenital malformations

Secondary outcomes

  1. preterm birth

    Time frame: up to 37 gestational weeks

    Number of pregnancies with preterm birth

  2. low birth weight

    Time frame: Immediately after delivery

    Number of live births with low birth weight

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Collaborators

  • Xiamen Health Commission
  • Xiamen Health and Medical Big Data Center

Registry information

Important dates

Study start
2013
Primary completion
2021
Study completion
2022
First posted
Nov 17, 2022
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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