Ningbo Maternity-Child Linked Database Study

NCT06422130 | Active Not Recruiting

• 1 other identifier: NBU-2023-240
• Study Type: observational
• Target: 325,596
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnant Women; Children

Keywords

Population-based healthcare database; Longitudinal study; Ambispective Cohort; Pregnant women and offspring

Outcome Measures

Primary Outcomes (13)

• Incidence of preterm birth

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  Deaths among live births during the first 28 completed days of life.

  Within 28 days after delivery

Study Arms (1)

Pregnant women and their offspring

Other: Pregnant women and their offspring without intervention

Interventions

Pregnant women and their offspring without intervention OTHER

Pregnant women and their offspring with those exposures of interest determined in specific research based on the database

Pregnant women and their offspring

Eligibility Criteria

• Gender Eligibility Details: All pregnant women and their offspring registered at the Ningbo maternal and child health electronic monitoring information management system were enrolled.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Ningbo University: lead
• Ningbo Health Information Center: collaborator

Study Sites (1)

Ningbo University

Ningbo, Zhejiang, 315000, China

Location

Related Publications (1)

• Li N, Ye H, Zhu H, Liang M, Wang K, Zhao Y, Liu L. Association of prenatal exposure to air pollution with autism spectrum disorder: A population-based retrospective cohort study in China. Environ Res. 2026 Feb 15;291:123612. doi: 10.1016/j.envres.2025.123612. Epub 2025 Dec 22.

  PMID: 41443491 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 20, 2024
• Study Start: October 1, 2016
• Primary Completion: December 31, 2021
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

CN (1)