- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06422130
Ningbo Maternity-Child Linked Database Study (MATCHLESS)
Ningbo Maternity-Child Linked Database Study(MATCHLESS): Using Electronic Health Records to Improve Maternal and Child Health Care and Outcomes in China
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Zhejiang
-
Ningbo, Zhejiang, China, 315000
- Ningbo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant women and their offspring who registered at the Ningbo maternal and child health electronic monitoring information management system.
Exclusion Criteria:
- None.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pregnant women and their offspring
|
Pregnant women and their offspring with those exposures of interest determined in specific research based on the database
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of preterm birth
Time Frame: Up to 42 weeks
|
Regular contractions accompanied by cervical change at less than 37 weeks' gestation. Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O60. |
Up to 42 weeks
|
Incidence of pre-eclampsia
Time Frame: Up to 42 weeks
|
New onset hypertension (>140 mm Hg systolic or >90 mm Hg diastolic) after 20 weeks of pregnancy and the coexistence of one or both of the following new-onset conditions: proteinuria (urine protein:creatinine ratio ≥30 mg/mmol, or albumin: creatinine ratio ≥8 mg/mmol, or ≥1 g/L [2+] on dipstick testing), other maternal organ dysfunction, including features such as renal or liver involvement, neurological or haematological complications, or uteroplacental dysfunction (such as fetal growth restriction, abnormal umbilical artery Doppler waveform analysis, or stillbirth). Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O14. |
Up to 42 weeks
|
Incidence of eclampsia
Time Frame: Up to 42 weeks
|
The occurrence of new-onset, generalized, tonic-clonic seizures or coma in a patient with preeclampsia or gestational hypertension. Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O15. |
Up to 42 weeks
|
Incidence of gestational diabetes mellitus
Time Frame: Up to 42 weeks
|
Impaired Glucose Tolerance (IGT) with onset or first recognition during pregnancy. Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O24.4. |
Up to 42 weeks
|
Incidence of low birth weight
Time Frame: Up to 42 weeks
|
Weight at birth of < 2500 g. Or, at least one of the following diagnoses in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : P07.0, P07.1. |
Up to 42 weeks
|
Incidence of small for gestational age
Time Frame: Up to 42 weeks
|
Less than the tenth birth weight centile using INTERGROWTH-21st. Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : P05. |
Up to 42 weeks
|
Incidence of autism
Time Frame: Up to 10 years
|
The following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : F84.
|
Up to 10 years
|
Incidence of birth defects
Time Frame: Up to 10 years
|
Birth defects such as congenital malformations of the nervous system, congenital malformations of eye, ear, face and neck, congenital malformations of the circulatory system, congenital malformations of the respiratory system, or other birth defects. Or, at least one of the following diagnoses in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : Q00-Q99. |
Up to 10 years
|
Incidence of postpartum hemorrhage
Time Frame: Within 24 hours after delivery
|
Blood loss exceeding 500 mL following vaginal birth and 1000 mL following cesarean. Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O72. |
Within 24 hours after delivery
|
Incidence of stillbirth
Time Frame: Up to 42 weeks
|
Death of a fetus that has reached a birth weight of 500 g, or if birth weight is unavailable, gestational age of 22 weeks or crown-to-heel length of 25 cm. Or, at least one of the following diagnoses in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : Z37.1, Z37.3, Z37.4, Z37.7. |
Up to 42 weeks
|
Incidence of ruptured uterus
Time Frame: Up to 42 weeks
|
Uterine rupture is confirmed by laparotomy. Or, at least one of the following diagnoses in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O71.0, O71.1, O34.5, O62.4. |
Up to 42 weeks
|
Incidence of maternal death
Time Frame: Up to 52 weeks
|
Death of women while pregnant or within 42 days of termination of pregnancy irrespective of the site and size of pregnancy but related to or aggravated by the pregnancy or its management but not from accidental or incidental causes.
|
Up to 52 weeks
|
Incidence of neonatal death
Time Frame: Within 28 days after delivery
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Deaths among live births during the first 28 completed days of life.
|
Within 28 days after delivery
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NBU-2023-240
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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