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A Risk Score for Prediction of Gestational Diabetesmellitus in China Using Routinely Collected Hospital Data

A Risk Score for Prediction of Gestational Diabetesmellitus in China Using Routinely Collected Hospital Data

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07160920
Enrollment
6608
Registered
2025-09-08
Start date
2021-01-26
Completion date
2023-12-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus (GDM)

Brief summary

This project will recruit 6,608 pregnant women in the early stage of pregnancy in Beijing and across the country. Researchers (prenatal examination doctors) will collect the basic information of pregnant women and the results of early pregnancy laboratory tests through hospital systems (HIS and LIS systems). The dietary frequency and exercise information of pregnant women were collected through questionnaire surveys: A 75g oral glucose tolerance test (0GTT test) was conducted at 24-28 weeks. Follow-up was conducted until the completion of the 75gOGTT test, and the delivery outcomes were recorded. By making the subjects pay attention to their own physical conditions through the project, abnormalities can be detected early. At the same time, early prediction of gestational diabetes mellitus enables doctors and health physicians to identify high-risk groups for gestational diabetes mellitus (GDM) at an early stage and carry out early intervention, reducing GDM and related pregnancy complications, promoting the health of mothers and infants, and reducing the additional medical expenses that may be borne for GDM management and the overall medical expenditure of the country in the future.

Interventions

OTHERCollect clinical data of pregnant women

Collect clinical data of pregnant women

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 50 Years

Inclusion criteria

* All pregnant women with single pregnancies in the early stage of pregnancy who have registered in the hospital are eligible to participate in the proposed program.

Exclusion criteria

Pregnant women with a known history of type 1 or type 2 diabetes will be excluded.

Design outcomes

Primary

MeasureTime frame
apgar scoreDuring childbirth
Complications during pregnancyDuring childbirth
mode of deliveryDuring childbirth
premature rupture of membranesDuring childbirth
The length of a newbornDuring childbirth
Newborn weightDuring childbirth

Other

MeasureTime frame
Clinical Laboratory Indicators4 to 7 weeks of gestation, 24 to 28 weeks of gestation, and 37 to 38 weeks of gestation
height of pregnant womenBaseline
weight of pregnant womenBaseline
BMI of pregnant womenBaseline
Ultrasound examination results such as fetal biparietal diameter, head circumference, abdominal circumference and femoral length (unit: mm).From 28 weeks of gestation until delivery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026