## Protocol Section
### Identification Module
**NCT ID:** NCT06422130

**Acronym:** MATCHLESS

**Brief Title:** 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

#### Organization Study ID Info
**ID:** NBU-2023-240
#### Organization
**Class:** OTHER
**Full Name:** Ningbo University
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2021-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2016-10-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Ningbo Health Information Center

#### Lead Sponsor

**Class:** OTHER

**Name:** Ningbo University

#### Responsible Party

**Investigator Affiliation:** Ningbo University

**Investigator Full Name:** Liya Liu

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Pregnant Women

- Children

**Keywords:**

- Population-based healthcare database

- Longitudinal study

- Ambispective Cohort

- Pregnant women and offspring

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 325596

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 10 Years

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Pregnant women and their offspring without intervention

**Label:** Pregnant women and their offspring

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pregnant women and their offspring

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

**Name:** Pregnant women and their offspring without intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Incidence of preterm birth

**Time Frame:** Up to 42 weeks

**Description:** 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.

**Measure:** Incidence of pre-eclampsia

**Time Frame:** Up to 42 weeks

**Description:** 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.

**Measure:** Incidence of eclampsia

**Time Frame:** Up to 42 weeks

**Description:** 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.

**Measure:** Incidence of gestational diabetes mellitus

**Time Frame:** Up to 42 weeks

**Description:** 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.

**Measure:** Incidence of low birth weight

**Time Frame:** Up to 42 weeks

**Description:** 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.

**Measure:** Incidence of small for gestational age

**Time Frame:** Up to 42 weeks

**Description:** The following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : F84.

**Measure:** Incidence of autism

**Time Frame:** Up to 10 years

**Description:** 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.

**Measure:** Incidence of birth defects

**Time Frame:** Up to 10 years

**Description:** 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.

**Measure:** Incidence of postpartum hemorrhage

**Time Frame:** Within 24 hours after delivery

**Description:** 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.

**Measure:** Incidence of stillbirth

**Time Frame:** Up to 42 weeks

**Description:** 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.

**Measure:** Incidence of ruptured uterus

**Time Frame:** Up to 42 weeks

**Description:** 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.

**Measure:** Incidence of maternal death

**Time Frame:** Up to 52 weeks

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

**Measure:** Incidence of neonatal death

**Time Frame:** Within 28 days after delivery

### Eligibility Module

**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.

**Gender Based:** True

**Gender Description:** All pregnant women and their offspring registered at the Ningbo maternal and child health electronic monitoring information management system were enrolled.

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ningbo

**Country:** China

**Facility:** Ningbo University

**State:** Zhejiang

**Zip:** 315000

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
