Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2026-01-02 @ 5:40 AM
Study NCT ID:
NCT03301792
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-19
First Post:
2017-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Group Versus Traditional Prenatal Care for Diabetes
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': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 117}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2017-09-15', 'studyFirstSubmitQcDate': '2017-10-03', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Diabetes Group Care on maternal glycemic control', 'timeFrame': 'Initial study visit (22-34 weeks) through one year postpartum', 'description': 'Determine the effect of Diabetes Group care on maternal glycemic control by randomizing women to Diabetes group care or traditional care and compare 1) Mean fasting blood glucose, 2) Mean 1-hour post-prandial blood glucose, and 3) Hemoglobin A1c at delivery, 4-12 weeks postpartum, six months postpartum, one year postpartum'}, {'measure': 'Effect of Diabetes Group Care on postpartum weight retention', 'timeFrame': 'Pre-pregnancy weight (up to 6 months prior to initial visit) through one year postpartum', 'description': 'Determine the impact of Diabetes Group care on postpartum weight retention in pounds based on postpartum weight retention at one year. Average weight retention will be compared at 4-12 weeks, six months postpartum, and one year postpartum.'}], 'secondaryOutcomes': [{'measure': 'Completion of self-care activities', 'timeFrame': '37-39 weeks gestation', 'description': 'Determine the effect of Diabetes Group care on maternal diabetes self-care activities by using the Diabetes Self-care Activities Scale (a measure of the number of days during the prior week in which the subject followed diet, exercise, blood sugar testing, and medication adherence recommendations)'}, {'measure': 'Effect of Diabetes Group Care on number of blood glucose values', 'timeFrame': 'Initial study visit (22-34 weeks) through 39 weeks gestation', 'description': 'Determine the effect of Diabetes Group care by measuring the percentage of recommended blood glucose values entered on logs since initial study visit'}, {'measure': 'Maternal Antepartum Compliance', 'timeFrame': 'Initial study visit (22-34weeks) through 4-12 weeks postpartum', 'description': 'Determine the effect of Diabetes Group Care on maternal antepartum compliance by assessing the number of prenatal appointments attended'}, {'measure': 'Maternal Antepartum Physical Activity/Eating Behavior', 'timeFrame': 'Initial study visit (22-34weeks) through one year postpartum', 'description': 'Determine the effect of Diabetes Group Care on maternal antepartum physical activity/eating behavior using a physical activity/eating behavior questionnaire'}, {'measure': 'Maternal Antepartum Weight Gain', 'timeFrame': 'Initial study visit (22-34weeks) through delivery', 'description': 'Determine the effect of Diabetes Group Care on maternal antepartum weight gain in pounds'}, {'measure': 'Maternal Intrapartum Mode of Delivery', 'timeFrame': 'Delivery through 4-12 weeks postpartum', 'description': 'Determine the effect of Diabetes Group Care on maternal intrapartum mode of delivery by assessing whether infant was delivered spontaneously, using vacuum, forceps, or cesarean.'}, {'measure': 'Maternal Intrapartum Hypertensive Disease of Pregnancy', 'timeFrame': 'Delivery through 4-12 weeks postpartum', 'description': 'Determine the effect of Diabetes Group Care on maternal intrapartum hypertensive disorders of pregnancy by assessing whether they develop gestational hypertension, preeclampsia, or eclampsia.'}, {'measure': 'Maternal Postpartum Readmission', 'timeFrame': '4-12 weeks postpartum', 'description': 'Determine the effect of Diabetes Group Care on maternal postpartum readmission by assessing number of maternal hospital readmissions within 6 weeks postpartum.'}, {'measure': 'Maternal Postpartum Visit Attendance', 'timeFrame': '4-12 weeks postpartum', 'description': 'Determine the effect of Diabetes Group Care on maternal postpartum visit attendance by assessing whether she attends a postpartum visit between 4-12 weeks postpartum.'}, {'measure': 'Maternal Postpartum Glucose Testing', 'timeFrame': '4-12 weeks postpartum', 'description': 'Determine the effect of Diabetes Group Care on maternal postpartum glucose testing'}, {'measure': 'Maternal Postpartum Breastfeeding', 'timeFrame': '4-12 weeks postpartum, six months postpartum, one year postpartum', 'description': 'Determine the effect of Diabetes Group Care on maternal postpartum breastfeeding using a breastfeeding scale questionnaire'}, {'measure': 'Maternal Postpartum Contraception', 'timeFrame': '4-12 weeks postpartum, six months postpartum, one year postpartum', 'description': 'Determine the effect of Diabetes Group Care on maternal postpartum contraception choices by assessing use of short acting reversible contraception, long acting reversible, and sterilization.'}, {'measure': 'Neonatal Birthweight', 'timeFrame': 'delivery admission', 'description': 'Determine the effect of Diabetes Group Care on neonatal birth weight in grams'}, {'measure': 'Neonatal Gestational Age', 'timeFrame': 'delivery admission', 'description': 'Determine the effect of Diabetes Group Care on neonatal gestational age at delivery'}, {'measure': 'Neonatal APGAR Scores', 'timeFrame': 'delivery admission', 'description': 'Determine the effect of Diabetes Group Care on neonatal APGAR score'}, {'measure': 'Neonatal Adiposity and body composition', 'timeFrame': 'delivery admission through one year postpartum', 'description': 'Determine the effect of Diabetes Group Care on neonatal adiposity and body composition by air displacement plethysmography within 1 week of delivery. Skin fold thickness of triceps, subscapular, ilium, and thigh at delivery, six weeks, six months, one year postpartum.'}, {'measure': 'Neonatal body measurements-Weight', 'timeFrame': 'delivery through one year postpartum', 'description': 'Determine the effect of Diabetes Group Care on neonatal weight in grams'}, {'measure': 'Neonatal body measurements-Length', 'timeFrame': 'delivery through one year postpartum', 'description': 'Determine the effect of Diabetes Group Care on neonatal length in centimeters'}, {'measure': 'Neonatal body measurements-Head Circumference', 'timeFrame': 'delivery through one year postpartum', 'description': 'Determine the effect of Diabetes Group Care on neonatal head circumference in centimeters'}, {'measure': 'Neonatal NICU Admission', 'timeFrame': 'delivery admission', 'description': 'Determine the effect of Diabetes Group Care on neonatal NICU admission'}, {'measure': 'Neonatal Hypoglycemia', 'timeFrame': 'delivery admission', 'description': 'Determine the effect of Diabetes Group Care on neonatal hypoglycemia'}, {'measure': 'Neonatal Outcomes', 'timeFrame': 'delivery admission', 'description': 'Determine the effect of Diabetes Group Care on neonatal hematocrit'}, {'measure': 'Neonatal Jaundice', 'timeFrame': 'delivery admission', 'description': 'Determine the effect of Diabetes Group Care on neonatal jaundice'}, {'measure': 'Neonatal Stillbirth Rates', 'timeFrame': 'delivery admission', 'description': 'Determine the effect of Diabetes Group Care on neonatal stillbirth rates'}, {'measure': 'Psychosocial Stress', 'timeFrame': 'Initial study visit (22-34weeks) through one year postpartum', 'description': "Determine the effect of Diabetes Group Care on psychosocial stress by comparing Cohen's Perceived Stress at study entry visit, last study visit (37-39 weeks) and 4-12 weeks postpartum, six months postpartum, one year postpartum."}, {'measure': 'Psychosocial Stress', 'timeFrame': 'Initial study visit (22-34weeks) and six months postpartum', 'description': 'Determine the effect of Diabetes Group Care on psychosocial stress by comparing life events checklist at study entry visit and six months postpartum'}, {'measure': 'Psychosocial Distress', 'timeFrame': 'Initial study visit (22-34 weeks) through 4-12 weeks postpartum', 'description': 'Determine the effects of Diabetes Group Care on psychosocial stress by comparing Pregnancy Distress questionnaire at study entry, last study visit (37-39 weeks), and 4-12 weeks postpartum'}, {'measure': 'Psychosocial Anxiety', 'timeFrame': 'Initial study visit (22-34weeks) through one year postpartum', 'description': 'Determine the effects of Diabetes Group Care on psychosocial stress by comparing GAD-7 at study entry, last study visit (37-39weeks) and 4-12 weeks postpartum, six months postpartum, one year postpartum.'}, {'measure': 'Psychosocial Depression', 'timeFrame': 'Initial study visit (22-34weeks) through 1 year postpartum', 'description': 'Determine the effects of Diabetes Group Care on depression by comparing the Edinburgh Postnatal Depression Scale at study entry, last study visit (37-39 weeks) and 4-12 weeks postpartum, six months postpartum, one year postpartum'}, {'measure': 'Psychosocial Stress and Depression', 'timeFrame': 'Delivery through postpartum', 'description': 'Determine the effects of Diabetes Group Care on stress and depression by measuring alcohol or drug use in first year postpartum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Group prenatal care', 'Diabetes'], 'conditions': ['Pregnancy', 'Gestational Diabetes', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The investigators primary objective is to conduct a randomized trial to determine the effect of diabetes group prenatal care on glycemic control and postpartum weight retention in women with type 2 diabetes and gestational diabetes.', 'detailedDescription': 'Long term, the investigator aims to test the central hypothesis that group prenatal care, compared to traditional prenatal care, will improve, 1.) glycemic control and, 2.) postpartum weight retention in women with type 2 and gestational diabetes. The objective of this proposal is to conduct a randomized trial in two phases to determine the effect of Diabetes Group Care (GC) on glycemic control in pregnant women with T2DM and GDM (Antepartum Phase) and the impact on postpartum weight retention (Postpartum Phase).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. English speaking\n2. Type 2 diabetes OR gestational diabetes diagnosed by 2-step method(1) OR likely pre-existing Type 2 diabetes with one of the following during pregnancy and \\</= 34 weeks:\n\n 1. 1 hour glucose challenge test \\>/= 185mg/dL OR\n 2. A1c \\>/= 6.5% OR\n 3. Fasting plasma glucose \\> 126mg/dL (2)\n3. Ability to attend group prenatal visit at specified days and times\n4. Willingness to be randomized at 22 weeks 0 days-34 weeks 0 days OR initial visit between 24 weeks 0 days-34 weeks 0 days\n5. Ability to give informed consent\n\nExclusion Criteria:\n\n1. Prior participation in diabetes group care\n2. Type 1 Diabetes\n3. Multiple gestation\n4. Major fetal anomaly\n5. Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider.\n6. Serious psychiatric illness including schizophrenia necessitating more care than can safely be provided in group setting, as deemed by medical provider.'}, 'identificationModule': {'nctId': 'NCT03301792', 'briefTitle': 'Group Versus Traditional Prenatal Care for Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Group Versus Traditional Prenatal Care for Diabetes: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '201707118; 201906068 (1001)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Routine Prenatal Care', 'description': 'Subjects randomized to routine care will receive their care in the usual diabetic clinic attended by residents and faculty. They will receive consultation with the diabetes educator at diagnosis and as needed. Patients are seen every 2 weeks (or more by provider discretion) until 37 weeks and weekly until delivery. Visits are 10-15 minutes and focus on routine screening tests and review of blood sugar logs/medication titration.'}, {'type': 'EXPERIMENTAL', 'label': 'Group prenatal care', 'description': 'Group visits will be held every 2 weeks in a continuous cycle through a six session curriculum. Women will have weekly visits beginning at 37 weeks with traditional prenatal visits on the weeks when the group does not meet. Groups of 2-12 women will meet for two hour visits and much of that time will be spent on pregnancy, behavioral health, diabetes and nutrition education. Groups will be co-facilitated by a health educator and an obstetric provider. Women may be instructed to have additional visits in the traditional clinic at the discretion of the obstetric provider.', 'interventionNames': ['Behavioral: Group prenatal care']}], 'interventions': [{'name': 'Group prenatal care', 'type': 'BEHAVIORAL', 'description': 'Enrolled subjects will be randomly assigned in a 2:1 ratio to group or traditional care.', 'armGroupLabels': ['Group prenatal care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Megan Lawlor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor, Washington University in St. Louis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}