Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT05202002
Status:
UNKNOWN
Last Update Posted:
2022-02-04
First Post:
2022-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Decrease Type II Diabetes in Gestational Diabetes Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], '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': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006943', 'term': 'Hyperglycemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-22', 'studyFirstSubmitDate': '2022-01-08', 'studyFirstSubmitQcDate': '2022-01-08', 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of type II Diabetes Mellitus (DM) diagnosis, as diagnosed by the 75gm oral glucose tolerance test (OGTT)', 'timeFrame': 'A phone call at 6 weeks postpartum.', 'description': 'Participants are requested to perform 75gm oral glucose tolerance test (OGTT) postpartum, as a screening test for type I diabetes mellitus. We will record the results and compare between groups'}], 'secondaryOutcomes': [{'measure': 'Rate of OGTT performance', 'timeFrame': 'A phone call at 6 weeks postpartum.', 'description': 'Determination the actual performance of the test'}, {'measure': 'Rate of impaired glucose tolerance (IGT)', 'timeFrame': 'A phone call at 6 weeks postpartum.', 'description': 'Similar to primary outcome'}, {'measure': 'Rate of exclusive breastfeeding', 'timeFrame': 'A phone call at 6 weeks postpartum.', 'description': 'Participants will be asked by a phone cell, about feeding habits, including exclusive, partial and no breastfeeding of the infant'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestational Diabetes', 'Diabetes Mellitus, Type 2', 'Breastfeeding', 'Diabetes Mellitus, Type 1', 'Impaired Glucose Tolerance']}, 'referencesModule': {'references': [{'pmid': '22011407', 'type': 'RESULT', 'citation': 'Gunderson EP, Hedderson MM, Chiang V, Crites Y, Walton D, Azevedo RA, Fox G, Elmasian C, Young S, Salvador N, Lum M, Quesenberry CP, Lo JC, Sternfeld B, Ferrara A, Selby JV. Lactation intensity and postpartum maternal glucose tolerance and insulin resistance in women with recent GDM: the SWIFT cohort. Diabetes Care. 2012 Jan;35(1):50-6. doi: 10.2337/dc11-1409. Epub 2011 Oct 19.'}, {'pmid': '28244064', 'type': 'RESULT', 'citation': 'McFadden A, Gavine A, Renfrew MJ, Wade A, Buchanan P, Taylor JL, Veitch E, Rennie AM, Crowther SA, Neiman S, MacGillivray S. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2017 Feb 28;2(2):CD001141. doi: 10.1002/14651858.CD001141.pub5.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the study is to examine the impact of an educational video on the rate of breastfeeding in mothers who had gestational diabetes mellitus, and the rate of type-II diabetes mellitus diagnosed postpartum.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant individuals aged over 18 years old\n* Diagnosed with Gestational Diabetes Mellitus (GDM) by 100gm oral glucose tolerance test (OGTT) done between week 24-28 of gestation, or by other criteria (50gm glucose challenge test (GCT) \\>200 mg/dl22 or having one abnormal value in OGTT )\n* Having pregestational diabetes (DM-I or DM-II)\n* Can read and understand Hebrew\n\nExclusion Criteria:\n\n* Delivery of a non-viable fetus'}, 'identificationModule': {'nctId': 'NCT05202002', 'briefTitle': 'Decrease Type II Diabetes in Gestational Diabetes Population', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'Decreasing the Incidence of Post-partum Type II Diabetes Mellitus in Gestational Diabetes Population- Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CMC-20-0041-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Educational video', 'description': 'Participants will receive an online video clip, explaining the benefits of breastfeeding.', 'interventionNames': ['Behavioral: Video clip']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Participants will not receive the video clip', 'interventionNames': ['Behavioral: No video clip']}], 'interventions': [{'name': 'Video clip', 'type': 'BEHAVIORAL', 'otherNames': ['Intervention group'], 'description': 'After obtaining written informed consent, participants received a sealed envelope containing a preprinted paper referral to an online website, with a unique identifier.\n\nAfter entering the online website, participants will be asked to enter the unique identifier they have received into a text box. Only those whose identifiers were predetermined to be associated with the intervention group will receive the intervention.\n\nThe intervention is twenty minutes long educational video clip, in which a brief discussion was presented, by an obstetrician, pediatrician, dietitian, and a breastfeeding consultant, each presenting the benefits of breastfeeding for mother and newborn.', 'armGroupLabels': ['Educational video']}, {'name': 'No video clip', 'type': 'BEHAVIORAL', 'otherNames': ['Control group'], 'description': 'Participants in this group will receive a unique identifier that belongs to the control group, thus no video clip will be displayed.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3436212', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Dana Koos, MD', 'role': 'CONTACT', 'email': 'danako@clalit.org.il', 'phone': '+97248250785'}], 'facility': 'Carmel MC', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Nadav Cohen, MD', 'role': 'CONTACT', 'email': 'nadavmed88@gmail.com', 'phone': '+97248250336'}], 'overallOfficials': [{'name': 'Nadav Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carmel MC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nadav Cohen', 'investigatorAffiliation': 'Carmel Medical Center'}}}}