Pregnant WomenMATCHLESSNCT06422130
Ningbo Maternity-Child Linked Database Study
An observational study of Pregnant Women and Children, run by Ningbo University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnant Women, Children
- What is being tested?
- Pregnant women and their offspring without intervention
- How many people
- 325,596 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2016to 31 Dec 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- 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.
Who may be able to join
- Pregnant women and their offspring who registered at the Ningbo maternal and child health electronic monitoring information management system.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this 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
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
- Being tested
- Pregnant women and their offspring without intervention
- Keywords
- Population-based healthcare database, Longitudinal study, Ambispective Cohort, Pregnant women and offspring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant women and their offspring without interventionOther
Pregnant women and their offspring with those exposures of interest determined in specific research based on the database
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women and their offspring | Not described Receives: Other: Pregnant women and their offspring without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 52 weeks
Incidence of neonatal death
Deaths among live births during the first 28 completed days of life.
Measured: Within 28 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Oct 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 325,596 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Ningbo University
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Health Information Center
- Responsible party
- Principal investigator, Liya Liu, Ningbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422130
- Sponsor's protocol ID
- NBU-2023-240
- Acronym
- MATCHLESS
- Status last verified
- May 2025
- First submitted
- 8 May 2024
- Last updated
- 25 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41443491
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ningbo Maternity-Child Linked Database Study(MATCHLESS): Using Electronic Health Records to Improve Maternal and Child Health Care and Outcomes in China
- ClinicalTrials.gov ID
- NCT06422130
- Acronym / sponsor ID
- MATCHLESS / NBU-2023-240
- Conditions
- Pregnant Women, Children
- Keywords
- Population-based healthcare database, Longitudinal study, Ambispective Cohort, Pregnant women and offspring
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 325,596 participants (actual)
- Lead sponsor
- Ningbo UniversityUniversity, hospital or other
- Collaborators
- Ningbo Health Information Center
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women and their offspring | – | Other: Pregnant women and their offspring without intervention |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Pregnant women and their offspring who registered at the Ningbo maternal and child health electronic monitoring information management system.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnant women and their offspring without interventionPregnant women and their offspring with those exposures of interest determined in specific research based on the database | Other | Pregnant women and their offspring |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Incidence of neonatal death
Time frame: Within 28 days after delivery
Deaths among live births during the first 28 completed days of life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Derived from this study: PubMed 41443491Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women and Children, run by Ningbo University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of preterm birth (time frame: Up to 42 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06422130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.