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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
564,760

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
Last Updated

November 17, 2022

Status Verified

November 1, 2022

Enrollment Period

9 years

First QC Date

November 3, 2022

Last Update Submit

November 10, 2022

Conditions

PregnancyCongenital MalformationDrug Exposure

Keywords

Cohort studydrug exposurescongenital malformationpregnancypopulation-based

Outcome Measures

Primary Outcomes (1)

  • congenital malformations

    Number of births with congenital malformations

    up to 42 days after delivery

Secondary Outcomes (2)

  • preterm birth

    up to 37 gestational weeks

  • low birth weight

    Immediately after delivery

Study Arms (1)

drug exposure

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

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

Interventions

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

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

drug exposure

Eligibility Criteria

Age14 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll pregnant women registered at the Maternal and Child Health Management Platform were enrolled.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiamen Health and Medical Big Data Center

Xiamen, Fujian, 361008, China

Location

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

  • Xin Sun

    Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Chinese Evidence-based Medicine Center

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 17, 2022

Study Start

January 1, 2013

Primary Completion

December 31, 2021

Study Completion

November 1, 2022

Last Updated

November 17, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP

Locations

CN(1)