Gestational Diabetes Mellitus (GDM)NCT07160920
A Risk Score for Prediction of Gestational Diabetesmellitus in China Using Routinely Collected Hospital Data
An observational study of Gestational Diabetes Mellitus (GDM), run by Peking Union Medical College Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Collect clinical data of pregnant women
- How many people
- 6,608 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 to 50 years
- Women only
- Adult
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
Who may be able to join
- 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.
Who cannot join
- Pregnant women with a known history of type 1 or type 2 diabetes will be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
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)
- Being tested
- Collect clinical data of pregnant women
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect clinical data of pregnant womenOther
Collect clinical data of pregnant women
| Study group | Role | What they receive |
|---|---|---|
| pregnant woman | Not described Receives: Other: Collect clinical data of pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications during pregnancy
Measured: During childbirth
mode of delivery
Measured: During childbirth
premature rupture of membranes
Measured: During childbirth
The length of a newborn
Measured: During childbirth
Newborn weight
Measured: During childbirth
apgar score
Measured: During childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start26 Jan 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6,608 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160920
- Sponsor's protocol ID
- JS-2763
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Risk Score for Prediction of Gestational Diabetesmellitus in China Using Routinely Collected Hospital Data
- ClinicalTrials.gov ID
- NCT07160920
- Acronym / sponsor ID
- JS-2763
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,608 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Sep 2025 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant woman | – | Other: Collect clinical data of pregnant women |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnant women with a known history of type 1 or type 2 diabetes will be excluded.
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 |
|---|---|---|
| Collect clinical data of pregnant womenCollect clinical data of pregnant women | Other | pregnant woman |
Primary outcome
Complications during pregnancy
Time frame: During childbirth
mode of delivery
Time frame: During childbirth
premature rupture of membranes
Time frame: During childbirth
The length of a newborn
Time frame: During childbirth
Newborn weight
Time frame: During childbirth
apgar score
Time frame: During childbirth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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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 Gestational Diabetes Mellitus (GDM), run by Peking Union Medical College Hospital 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: finished, as of the sponsor's last update on 8 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complications during pregnancy (time frame: During childbirth). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.