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

NCT07160920 | Completed

• 1 other identifier: JS-2763
• Study Type: observational
• Target: 6,608
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus (GDM)

Outcome Measures

Primary Outcomes (6)

• Complications during pregnancy

  During childbirth

• mode of delivery

  During childbirth

• premature rupture of membranes

  During childbirth

• The length of a newborn

  During childbirth

• Newborn weight

  During childbirth

• apgar score

  During childbirth

Other Outcomes (5)

• Ultrasound examination results such as fetal biparietal diameter, head circumference, abdominal circumference and femoral length (unit: mm).

  From 28 weeks of gestation until delivery

• Clinical Laboratory Indicators

  4 to 7 weeks of gestation, 24 to 28 weeks of gestation, and 37 to 38 weeks of gestation

• height of pregnant women

  Baseline

Study Arms (1)

pregnant woman

Other: Collect clinical data of pregnant women

Interventions

Collect clinical data of pregnant women OTHER

Collect clinical data of pregnant women

pregnant woman

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All pregnant women who have registered their medical records at Peking Union Medical College Hospital and have not had diabetes before pregnancy are eligible to participate in this project

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: September 8, 2025
• Study Start: January 26, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)