Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-03-22 @ 3:51 PM
Study NCT ID:
NCT02035059
Status:
COMPLETED
Last Update Posted:
2019-04-26
First Post:
2014-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictability of Gestational Diabetes Mellitus in First and Second Trimester
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D003919', 'term': 'Diabetes Insipidus'}], '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'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood Saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 820}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-25', 'studyFirstSubmitDate': '2014-01-12', 'studyFirstSubmitQcDate': '2014-01-13', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of Gestational Diabetes in second/third trimester', 'timeFrame': '24-28 weeks of gestation', 'description': 'Development of gestational diabetes in 24-28 weeks of gestation by pathological values in oral glucose tolerance test 75g'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oral Glucose Tolerance Test', 'Fibronectin', 'Adiponectin', 'Copeptin', 'Cortisol'], 'conditions': ['Pregnancy', 'Gestational Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '40817933', 'type': 'DERIVED', 'citation': 'Huhn EA, Kotzaeridi G, Fischer T, Todesco Bernasconi M, Richter AS, Kunze M, Dolzlmuller E, Jaksch-Bogensperger H, Weidinger L, Eppel D, Ochsenbein-Koelble N, Baz E, Winzeler B, Tura A, Stach H, Schafer G, van Breda SV, Vokalova L, Hoesli I, Gobl CS. The utility of early gestational OGTT and biomarkers for the development of gestational diabetes mellitus: an international prospective multicentre cohort study. Diabetologia. 2025 Nov;68(11):2511-2522. doi: 10.1007/s00125-025-06517-0. Epub 2025 Aug 16.'}, {'pmid': '37720695', 'type': 'DERIVED', 'citation': 'Huhn EA, Gobl CS, Fischer T, Todesco Bernasconi M, Kreft M, Kunze M, Vogt DR, Dolzlmuller E, Jaksch-Bogensperger H, Heldstab S, Eppel W, Husslein P, Ochsenbein Kolble N, Richter A, Baz E, Winzeler B, Hoesli I. Sensitivity, specificity, and diagnostic accuracy of WHO 2013 criteria for diagnosis of gestational diabetes mellitus in low risk early pregnancies: international, prospective, multicentre cohort study. BMJ Med. 2023 Sep 13;2(1):e000330. doi: 10.1136/bmjmed-2022-000330. eCollection 2023.'}, {'pmid': '27733413', 'type': 'DERIVED', 'citation': 'Huhn EA, Fischer T, Gobl CS, Todesco Bernasconi M, Kreft M, Kunze M, Schoetzau A, Dolzlmuller E, Eppel W, Husslein P, Ochsenbein-Koelble N, Zimmermann R, Baz E, Prompeler H, Bruder E, Hahn S, Hoesli I. Screening of gestational diabetes mellitus in early pregnancy by oral glucose tolerance test and glycosylated fibronectin: study protocol for an international, prospective, multicentre cohort trial. BMJ Open. 2016 Oct 12;6(10):e012115. doi: 10.1136/bmjopen-2016-012115.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is, if an early oral glucose tolerance test combined with maternal history, condition and multiple biomarker analysis can be used to detect gestational diabetes mellitus in the first trimester (12-14 weeks of gestation).', 'detailedDescription': "It is the investigators' aim to prospectively examine an extended form of the current 1st trimester screening test for the detection of foetal aneuploidy, in order to ascertain whether this can also be used for the detection of patients at-risk for gestational diabetes mellitus. For this purpose the investigators will include a combination of new markers in a multiplex bio-array manner in conjunction with an early oral glucose tolerance test. A nested case-control proteomic analysis will be performed in a retrospective manner at the completion of this study in order to develop more specific biomarker panels.\n\nThe primary outcome will be development of gestational diabetes mellitus in the second or third trimester.\n\nThe secondary endpoints are the delivery outcome, neonatal morbidity, neonatal mortality, maternal morbidity and costs."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant Women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy singleton pregnancies\n* Women at least 18 years old and not under guardianship\n\nExclusion Criteria:\n\n* Maternal diseases like hypertension, diabetes mellitus and chronic disease, known infection like hepatitis or human immunodeficiency virus\n* Maternal history of hypertensive diseases in previous pregnancy and now under prophylactic acetylsalicylate treatment\n* Foetal genetic, chromosomal or intervention-requiring morphologic abnormalities'}, 'identificationModule': {'nctId': 'NCT02035059', 'acronym': 'GDMPredict', 'briefTitle': 'Predictability of Gestational Diabetes Mellitus in First and Second Trimester', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Predictability of Gestational Diabetes Mellitus in First and Second Trimester, Using Novel Biomarkers, and the Development of New Biomarkers by Quantitative Proteomic Analysis', 'orgStudyIdInfo': {'id': 'EKBB195/13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with/without gestational diabetes', 'description': 'Women with/without gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': "Women's Hospital, University Basel", 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Evelyn Huhn, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Women's Hospital, University Basel"}, {'name': 'Irene Hösli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Women's Hospital, University Basel"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Zürich', 'class': 'OTHER'}, {'name': 'Cantonal Hospital of Aarau, Switzerland', 'class': 'OTHER'}, {'name': 'Vienna General Hospital', 'class': 'OTHER'}, {'name': 'Paracelsus Medical University', 'class': 'OTHER'}, {'name': 'University Hospital Freiburg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}