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NCT Number: NCT06422130

Ningbo Maternity-Child Linked Database Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pregnant Women Children

Sex eligibility

Female

Study type

Observational

Primary location

Ningbo University

Ningbo, Zhejiang, 315000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None.

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Incidence of neonatal death

    Time frame: Within 28 days after delivery

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

Sponsors and collaborators

Lead sponsor

Ningbo University

Other

Collaborators

  • Ningbo Health Information Center

Registry information

Official study title

Ningbo Maternity-Child Linked Database Study(MATCHLESS): Using Electronic Health Records to Improve Maternal and Child Health Care and Outcomes in China

Acronym: MATCHLESS

Important dates

Study start
2016
Primary completion
2021
Study completion
2026
First posted
May 20, 2024
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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