Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 12:35 PM
Study NCT ID:
NCT05596812
Status:
UNKNOWN
Last Update Posted:
2022-10-27
First Post:
2022-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2022-10-24', 'lastUpdatePostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the novel risk stratification screening tool', 'timeFrame': '2 years', 'description': 'number of patients screened, recruited, consented and randomized as documented in the study recruitment log'}], 'secondaryOutcomes': [{'measure': 'Performance of the GDM risk stratification tool', 'timeFrame': '2 years', 'description': 'With regards to identification of women with GDM who maintain euglycemia on lifestyle modification alone in the "Low-risk GDM" group. Sensitivity, specificity, and accuracy will be calculated.'}, {'measure': 'Glycemic control - blood glucose (units)', 'timeFrame': 'approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)', 'description': 'mean Fasting Plasma Glucose (FPG) and Post-Prandial Glucose (PPG) in mg/dL'}, {'measure': 'Glycemic control - blood glucose (percent above target)', 'timeFrame': 'approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)', 'description': 'percent above target Fasting Plasma Glucose (FPG) and Post-Prandial Glucose (PPG)'}, {'measure': 'Gestational weight gain', 'timeFrame': 'approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)', 'description': 'in kilograms (kg)'}, {'measure': 'Development of hypertensive disorders of pregnancy', 'timeFrame': 'approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)', 'description': 'documented as recorded from patient charts (Yes/No)'}, {'measure': 'Delivery outcomes - gestational age at delivery', 'timeFrame': 'recorded at time of delivery', 'description': 'measured in weeks'}, {'measure': 'Delivery outcomes - mode of delivery', 'timeFrame': 'recorded at time of delivery', 'description': 'vaginal/caesarean/spontaneous/instrumental/forceps/vacuum/combined'}, {'measure': 'Neonatal outcomes - size for gestational age', 'timeFrame': 'recorded at time of delivery', 'description': 'measured in grams'}, {'measure': 'Neonatal outcomes - Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score', 'timeFrame': 'recorded at delivery (at 1 minute and 5 minutes of age)', 'description': 'Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score is based on a total score of 1 to 10; The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. A score of 7 or above on the test is considered in good health. A lower score does not mean that the baby is unhealthy, but that the baby may need some immediate medical care, such as suctioning of the airways or oxygen to help him or her breathe better.'}, {'measure': 'Health service outcomes - health resource utilization', 'timeFrame': '2 years', 'description': 'total number of care encounters (categorized by department - endocrine, obstetric)'}, {'measure': 'Health service outcomes - Short-form Patient Satisfaction Questionnaire (PSQ-18)', 'timeFrame': '2 years; administered to each participant at 6-weeks postpartum', 'description': 'Short-form Patient Satisfaction Questionnaire (PSQ-18); responses to items are measured on a 5-point Likert scale (1 = Strongly Agree, 5 = Strongly Disagree). Minimum score is 18, maximum score is 90. Higher scores indicate satisfaction with medical care.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestational Diabetes Mellitus in Pregnancy']}, 'descriptionModule': {'briefSummary': 'This study is a randomized controlled trial to study the effect of the use of a risk stratification screening tool for high- and low-risk gestational diabetes mellitus (GDM), and the implementation of a new low-impact care pathway for women with low-risk GDM. The study will measure how well the screening tool and new care pathway are used, and the effect of the new low-impact care pathway on glycemic control, perinatal outcomes (large for gestational age, rate of labor induction, mode of delivery, obstetric anal sphincter injury, neonatal hypoglycemia, neonatal anthropometry) and health resource utilization in women with GDM that are at low-risk of dietary therapy failure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women able to understand and sign the study consent form\n* singleton pregnancy\n* planning to give birth to at St. Michael's Hospital\n* diagnosed with GDM between 24-32 weeks' gestation based on a positive GCT or GTT result as defined by the Canadian Diabetes Association Clinical Practice Guidelines\n\nExclusion Criteria:\n\n* Women with preexisting diabetes (Type 1 or 2 diabetes)\n* multiple gestation, or a diagnosis of GDM before 24 weeks' or after 32 weeks' gestation\n* not continuing care at St. Michael's Hospital after the DIP clinic visit"}, 'identificationModule': {'nctId': 'NCT05596812', 'briefTitle': 'A Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'A Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus', 'orgStudyIdInfo': {'id': '22-065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (Risk Stratification Pathway)', 'description': 'Those randomized to Intervention (Risk Stratification Pathway) will have their demographic and clinical data entered into the risk stratification screening calculator, and will be assigned to either "Low Risk" (Novel (Low Impact) Care Pathway) or "High Risk" (Routine Care Pathway) groups.\n\nWomen in the Routine Care Pathway group will be followed in the DIP clinic according to routine care protocols and will provide bi-weekly glucometer data.\n\nWomen in the Novel (Low Impact) Care Pathway group will be followed in the New Care Pathway, which will include continuation of lifestyle and dietary modification, continuation of capillary self blood glucose monitoring, and routine prenatal care.', 'interventionNames': ['Other: New Care Pathway']}, {'type': 'NO_INTERVENTION', 'label': 'Control (Routine Care)', 'description': 'Those randomized to Control (Routine Care) will continue in-person and virtual visits as per routine care protocols. This group will also provide bi-weekly glucometer data.'}], 'interventions': [{'name': 'New Care Pathway', 'type': 'OTHER', 'description': 'The New Care Pathway will include continuation of lifestyle and dietary modification, self-blood glucose monitoring, and routine prenatal care.', 'armGroupLabels': ['Intervention (Risk Stratification Pathway)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Howard Berger, MD', 'role': 'CONTACT', 'email': 'Howard.Berger@unityhealth.to', 'phone': '416 864 6060', 'phoneExt': '2395'}, {'name': 'Klaudia Szczech', 'role': 'CONTACT', 'email': 'Klaudia.Szczech@unityhealth.to', 'phone': '416 867 7460', 'phoneExt': '49092'}], 'facility': "St. Michael's Hospital (Unity Health Toronto)", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Howard Berger, MD', 'role': 'CONTACT', 'email': 'Howard.Berger@unityhealth.to', 'phone': '416 864 6060', 'phoneExt': '2395'}, {'name': 'Klaudia Szczech', 'role': 'CONTACT', 'email': 'klaudia.szczech@unityhealth.to', 'phone': '416 867 7460', 'phoneExt': '49092'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}