JiAngSu Maternal and INfant HEalth Database (JASMINE)

October 11, 2024 updated by: Yang Zhao

JiAngSu Maternal and INfant HEalth Database(JASMINE): Using Electronic Health Records to Improve Maternal and Child Health Care and Outcomes in China

With the implementation of China's universal two-child policy and a notable rise in adverse pregnancy outcomes, leveraging electronic health records (EHR) has become crucial for enhancing maternal health. Given the mature construction of the information platform and the well-established maternal and child health service system in Jiangsu Province, this study used the Jiangsu Health Information Platform to carry out the research on the JiAngSu Maternal and INfant hEalth database (JASMINE), which involved over 1.5 million mother-child pairs in Jiangsu Province.

JASMINE enables longitudinal follow-up of pregnant women and their offspring, facilitating the exploration of early-life exposures and their long-term outcomes through comprehensive data linkage. This longitudinal approach helps to clarify the relationship and etiological significance of risk factors associated with adverse pregnancy outcomes.It also permits the exploration of the health trajectory of women and children throughout their lives.

From January 2020 to December 2023, JASMINE has recorded extensive maternal and child health data, including socio-demographics, healthcare services, medications, and clinical outcomes.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 has been approved approved by the Institutional Review Board of Nanjing Medical University.

Ultimately, this research aims to identify key predictors of adverse pregnancy outcomes and inform public health policies to improve maternal and child health in Jiangsu Province. Future directions will include developing targeted interventions based on study findings to enhance health outcomes for mothers and infants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1570360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women and their offspring who registered at the Jiangsu maternal and child health information platform.

Description

Inclusion Criteria:

  • Pregnant women and their offspring who registered at the Jiangsu maternal and child health information platform.

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Pregnant women and their offspring

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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 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 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 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 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 neonatal death
Time Frame: Within 28 days after delivery
Deaths among live births during the first 28 completed days of life
Within 28 days after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yang Zhao

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ningbo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NMU-2024-808

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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