Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT07160920
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2025-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Risk Score for Prediction of Gestational Diabetesmellitus in China Using Routinely Collected Hospital Data
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6608}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-31', 'studyFirstSubmitDate': '2025-07-03', 'studyFirstSubmitQcDate': '2025-08-31', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Ultrasound examination results such as fetal biparietal diameter, head circumference, abdominal circumference and femoral length (unit: mm).', 'timeFrame': 'From 28 weeks of gestation until delivery'}, {'measure': 'Clinical Laboratory Indicators', 'timeFrame': '4 to 7 weeks of gestation, 24 to 28 weeks of gestation, and 37 to 38 weeks of gestation'}, {'measure': 'height of pregnant women', 'timeFrame': 'Baseline'}, {'measure': 'weight of pregnant women', 'timeFrame': 'Baseline'}, {'measure': 'BMI of pregnant women', 'timeFrame': 'Baseline'}], 'primaryOutcomes': [{'measure': 'Complications during pregnancy', 'timeFrame': 'During childbirth'}, {'measure': 'mode of delivery', 'timeFrame': 'During childbirth'}, {'measure': 'premature rupture of membranes', 'timeFrame': 'During childbirth'}, {'measure': 'The length of a newborn', 'timeFrame': 'During childbirth'}, {'measure': 'Newborn weight', 'timeFrame': 'During childbirth'}, {'measure': 'apgar score', 'timeFrame': 'During childbirth'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestational Diabetes Mellitus (GDM)']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\nPregnant women with a known history of type 1 or type 2 diabetes will be excluded.'}, 'identificationModule': {'nctId': 'NCT07160920', 'briefTitle': 'A Risk Score for Prediction of Gestational Diabetesmellitus in China Using Routinely Collected Hospital Data', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Risk Score for Prediction of Gestational Diabetesmellitus in China Using Routinely Collected Hospital Data', 'orgStudyIdInfo': {'id': 'JS-2763'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pregnant woman', 'interventionNames': ['Other: Collect clinical data of pregnant women']}], 'interventions': [{'name': 'Collect clinical data of pregnant women', 'type': 'OTHER', 'description': 'Collect clinical data of pregnant women', 'armGroupLabels': ['pregnant woman']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}