Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422130
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-08
Brief Title:
Ningbo Maternity-Child Linked Database Study
Sponsor:
Ningbo University
Organization:
Ningbo University
Study Overview
Official Title:
Ningbo Maternity-Child Linked Database StudyMATCHLESS Using Electronic Health Records to Improve Maternal and Child Health Care and Outcomes in China
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MATCHLESS
Brief Summary:
With the implementation of Chinas two-child policy and a marked increase in adverse pregnancy outcomes leveraging electronic health records EHR to enhance maternal and child healthcare and outcomes in China has emerged as a novel strategy to tackle this pivotal demographic and health challenge Given the mature construction of the information platform and the well-established maternal and child health service system in Ningbo this study utilized the Ningbo Maternal and Child Health Electronic Monitoring Information Management System and the Ningbo Regional Health Information Platform to conduct the Ningbo maternity-child linked database study MATCHLESS which involved over 300000 mother-child pairs in China MATCHLESS not only allows for longitudinal follow-up of pregnant women and their offspring but also expands its scope from prenatal exposure to long-term outcomes through data linkage The longitudinal scope of MATCHLESS facilitates the elucidation of the relationship and etiological significance of early-life exposures and adverse pregnancy outcomes It also permits the exploration of the health trajectory of women and children over their life-course
During the past 5 years October 2016 to December 2021 a substantial amount of maternal and child health data has been recorded in MATCHLESS including socio-demographics health care services and medications as well as clinical outcome events Additionally it contains longitudinal measurements on risk factors for adverse pregnancy outcomes which provides a robust foundation for future real-world studies of dynamic predictive models This study was approved by the Ethics Review Committee of the Ningbo University Health Science Center Considering the safety privacy and confidentiality concerns surrounding the storage and processing of personal EHR data the responsibility for data storage and management is undertaken by the Health Commission of Ningbo Researchers are required to submit applications to the local health department and all studies undergo ethical review and research registration procedures to access EHR data for health research purposes
During the past 5 years October 2016 to December 2021 a substantial amount of maternal and child health data has been recorded in MATCHLESS including socio-demographics health care services and medications as well as clinical outcome events Additionally it contains longitudinal measurements on risk factors for adverse pregnancy outcomes which provides a robust foundation for future real-world studies of dynamic predictive models This study was approved by the Ethics Review Committee of the Ningbo University Health Science Center Considering the safety privacy and confidentiality concerns surrounding the storage and processing of personal EHR data the responsibility for data storage and management is undertaken by the Health Commission of Ningbo Researchers are required to submit applications to the local health department and all studies undergo ethical review and research registration procedures to access EHR data for health research purposes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None