Clinical trial NCT06422130: Ningbo Maternity-Child Linked Database Study
Official title: Ningbo Maternity-Child Linked Database Study(MATCHLESS): Using Electronic Health Records to Improve Maternal and Child Health Care and Outcomes in China
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pregnant Women
Children
Keywords: Population-based healthcare database
Longitudinal study
Ambispective Cohort
Pregnant women and offspring
Lead sponsor: Ningbo University
Sponsor class: OTHER
Collaborators: name: Ningbo Health Information Center
First posted: 2024-05-20
Enrollment: 325596
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women and their offspring who registered at the Ningbo maternal and child health electronic monitoring information management system.

Brief summary: With the implementation of China's 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 300,000 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.


Eligibility criteria: Inclusion Criteria:

* Pregnant women and their offspring who registered at the Ningbo maternal and child health electronic monitoring information management system.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Incidence of preterm birth
timeFrame: Up to 42 weeks
measure: Incidence of pre-eclampsia
timeFrame: Up to 42 weeks
measure: Incidence of eclampsia
timeFrame: Up to 42 weeks
measure: Incidence of gestational diabetes mellitus
timeFrame: Up to 42 weeks
measure: Incidence of low birth weight
timeFrame: Up to 42 weeks
measure: Incidence of small for gestational age
timeFrame: Up to 42 weeks
measure: Incidence of autism
timeFrame: Up to 10 years
measure: Incidence of birth defects
timeFrame: Up to 10 years
measure: Incidence of postpartum hemorrhage
timeFrame: Within 24 hours after delivery
measure: Incidence of stillbirth
timeFrame: Up to 42 weeks
measure: Incidence of ruptured uterus
timeFrame: Up to 42 weeks
measure: Incidence of maternal death
timeFrame: Up to 52 weeks
measure: Incidence of neonatal death
timeFrame: Within 28 days after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo University
state: Zhejiang
Study officials:
References: