Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT01441518
Status:
COMPLETED
Last Update Posted:
2015-07-08
First Post:
2011-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006699', 'term': 'Home Care Services'}], 'ancestors': [{'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D009739', 'term': 'Nursing Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-07', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-09-26', 'lastUpdatePostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal mortality and morbidity rates', 'timeFrame': 'participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal'}, {'measure': 'Perinatal mortality and morbidity rates', 'timeFrame': 'participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal'}], 'secondaryOutcomes': [{'measure': 'Birth weight (classified as appropriate for gestational age = AIG, small for gestational age =SGA and large for gestational age = LGA)', 'timeFrame': 'birth weight will be assessed for an expected average of 9 months from the time of randomization'}, {'measure': 'Maternal hospitalizations for any causes (home care) and prolonged hospitalization (hospital care)', 'timeFrame': 'participants will be followed for maternal hospitalizations for any causes and prolonged hospitalization up to six weeks postnatal'}, {'measure': 'Infants repeated hospitalizations', 'timeFrame': 'infants will be followed for repeated hospitalizations up to six weeks postnatal'}, {'measure': 'Infants acute care visits', 'timeFrame': 'infants will be followed for acute care visits up to six weeks postnatal'}, {'measure': 'Length of stay for delivery', 'timeFrame': 'participants will be followed for length of stay for delivery, an expected average of 9 months'}, {'measure': 'Maternal prenatal and postpartum acute care visits', 'timeFrame': 'participants will be followed for maternal prenatal and postpartum acute care visits up to six weeks postnatal'}, {'measure': 'Biophysical profile tests', 'timeFrame': 'participants will be followed for biophysical profile tests up to six weeks postnatal'}, {'measure': 'Incidence of premature infants', 'timeFrame': 'participants will be followed regarding incidence of premature infants up to six weeks postnatal'}, {'measure': 'Postpartum repeated hospitalization', 'timeFrame': 'participants will be followed for Postpartum repeated hospitalization up to six weeks postnatal'}, {'measure': 'Glucose control', 'timeFrame': 'participants will be followed for glucose control up to six weeks postnatal'}, {'measure': 'Costs', 'timeFrame': 'costs will be assessed for an expected average of 9 months from the time of randomization'}]}, 'conditionsModule': {'conditions': ['Gestational Diabetes Mellitus', 'Pregestational Diabetes Mellitus', 'Mild Gestational Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'Pregnancies complicated by diabetes and mild gestational hyperglycemia are associated with increased perinatal and maternal complications. The most serious maternal complication is the risk of developing type 2 diabetes after 10-12 years of the delivery. Perinatal complications include fetal macrosomia with consequent increased risk of obstetrical trauma and hypoxia/asphyxia, high rates of cesarean section, respiratory distress syndrome, and metabolic disorders at birth. Regardless of the diagnosis of diabetes and mild gestational hyperglycemia, the perinatal outcome is directly related to maternal metabolic control. For the tight control of blood glucose, pregnant women are treated as home care (outpatient) or hospital care. Objective: To evaluate the cost-effectiveness and safety of home versus hospital care of gestational diabetes and mild gestational hyperglycemia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were diagnosed with gestational, pre gestational diabetes mellitus or mild gestational hyperglycemia. Patients should have one of the four criteria as following:\n* Patients with positive screening for GDM presenting a TTG of 75 g and one of the values below:\n\n * fasting glucose ≥ 92;\n * 1h ≥ 180; or\n * 2h ≥ 153 will be considered gestational diabetes mellitus (GDM) and these patients will be enrolled to a run-in phase consisting of diet and exercise during 15 days. If the patients still present an abnormal glycemic profile instead of the previous treatment with diet and exercise they will be enrolled in the study and randomized to either home or hospital care; or\n* Patients with pre gestational diabetes mellitus type 1 or 2; or\n* Patients with positive screening for GDM and presenting normal TTG of 75 g and abnormal glycemic profile, fasting ≥ 85 mg k/l 10 h to 18h post prandial ≥ 130 mg k/ ( Rudge et al,1990).\n* Normal TTG and an abnormal glycemic profile will be considered as mild gestational hyperglycemia\n* Patient provided written informed consent.\n\nExclusion Criteria:\n\n* Twin pregnancy diagnosed until the date of randomization or;\n* Fetal malformation diagnosed until the date of randomization.'}, 'identificationModule': {'nctId': 'NCT01441518', 'briefTitle': 'Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia', 'organization': {'class': 'OTHER', 'fullName': 'UPECLIN HC FM Botucatu Unesp'}, 'officialTitle': 'A Prospective Randomized Trial of Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia', 'orgStudyIdInfo': {'id': 'upeclin/HC/FMB-Unesp-52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home care', 'interventionNames': ['Other: Home care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hospital care', 'interventionNames': ['Other: Hospital care']}], 'interventions': [{'name': 'Home care', 'type': 'OTHER', 'description': 'Home care, sometimes called "ambulatory care" or "outpatient", was defined as the blood-glucose self-monitored by the pregnant women at home. This project will provide glucometers to all those who are randomized to home care. The women will receive training for glucose control in pre-defined days, with the glucometer to obtain the mean glucose. According to blood-glucose levels in glycemic profile, insulin dose will be maintained or altered both in gestational diabetes as in mild gestational hyperglycemia .', 'armGroupLabels': ['Home care']}, {'name': 'Hospital care', 'type': 'OTHER', 'description': 'Hospital care, sometimes called "acute care", was defined as control of maternal diabetes made at hospitals by admission to hospital. The blood-glucose and metabolic control are done in gestational diabetes and mild gestational hyperglycemia treated conventionally.\n\nThe hospitalized patients will have their glycemic control done in the hospital. . According to blood-glucose levels in glycemic profile , insulin dose will be maintained or altered both in gestational diabetes as in mild gestational hyperglycemia.\n\nAll the women of the study will be accompanied by a team of obstetricians specializing in high-risk pregnancies; residents; dietitians; nurses and neonatologists.', 'armGroupLabels': ['Hospital care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18618-970', 'city': 'Botucatu', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Faculdade de Medicina de Botucatu, Universidade Estadual Paulista', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}], 'overallOfficials': [{'name': 'Dr Regina El Dib, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UPECLIN HC FM Botucatu Unesp'}, {'name': 'Dr Marilza Rudge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UPECLIN HC FM Botucatu Unesp'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UPECLIN HC FM Botucatu Unesp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Silvana Andrea Molina Lima', 'investigatorAffiliation': 'UPECLIN HC FM Botucatu Unesp'}}}}