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Completed

NCT Number: NCT07160920

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

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.

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Key information

Age range

21 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collect clinical data of pregnant women

Other

Collect clinical data of pregnant women

Primary outcomes

  1. Complications during pregnancy

    Time frame: During childbirth

  2. mode of delivery

    Time frame: During childbirth

  3. premature rupture of membranes

    Time frame: During childbirth

  4. The length of a newborn

    Time frame: During childbirth

  5. Newborn weight

    Time frame: During childbirth

  6. apgar score

    Time frame: During childbirth

Other outcomes

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

    Time frame: From 28 weeks of gestation until delivery

  2. Clinical Laboratory Indicators

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

  3. height of pregnant women

    Time frame: Baseline

  4. weight of pregnant women

    Time frame: Baseline

  5. BMI of pregnant women

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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