Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 10:55 AM
Study NCT ID:
NCT07489456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Dysglycemia During Postpartum Period in Women With GDM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D011236', 'term': 'Prediabetic State'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-03-11', 'size': 163229, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-03-17T11:06', 'hasProtocol': True}, {'date': '2026-03-11', 'size': 188770, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-03-17T11:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized, open-label clinical trial with two parallel groups, aiming to evaluate the effect of sending reminder messages via institutional WhatsApp on the attendance rate at TOTG-75g in the postpartum period.\n\nEligible participants will be randomly allocated, using a computer-generated sequence, into two groups:\n\nControl Group (current practice): will not receive reminder messages for the exam.\n\nIntervention Group: will receive automatic reminder messages via WhatsApp on days D-7 and D-3 in relation to the scheduled date for the exam. If the patient does not attend, she will receive a single additional message on the following business day, offering the possibility of rescheduling. Rescheduled exams will not receive new reminders. The message sent will contain a read receipt request to ensure that the patient has received the text. If the patient requests to reschedule the exam before the originally scheduled date, we will consider the new date as D'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 182}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients that attend to the postpartum OGTT', 'timeFrame': 'From enrollment to the end of the recommended timeframe for postpartum OGTT (6 to 12 weeks after delivery)', 'description': 'Impact of electronic messages in the attendance rate of postpartum women with GDM at the TOTG-75g exam between 6 and 12 weeks after delivery'}], 'secondaryOutcomes': [{'measure': 'Dysglycemia rate according to diagnostic set of criteria', 'timeFrame': 'From enrollment to OGTT test (6 to 12 weeks after delivery)', 'description': 'Compare the prevalence of prediabetes and diabetes in the postpartum period according to two diagnostic strategies applied to the 75g OGTT:\n\nStrategy A (currently in use): fasting blood glucose measurements and measurements two hours after glucose loading Strategy B (under investigation): fasting blood glucose measurements and measurements one hour after glucose loading'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dysglycemia', 'gestational diabetes', 'prediabetes', 'diabetes', 'postpartum OGTT'], 'conditions': ['Gestational Diabetes Mellitus (GDM)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Milluzzo A, Manuella L, Frittitta L, Sciacca L. Efficacy of a phone reminder to improve adherence to post-partum glucose tolerance testing after gestational diabetes and clinical predictors of post-partum follow-up compliance. Diabetes Research and Clinical Practice. 2024 Apr;210:111653. Available from: https://doi.org/10.1016/j.diabres.2024.111653'}, {'type': 'BACKGROUND', 'citation': 'Egan AM, Dunne FP. Rethinking Postpartum Glucose Assessment: Is One-Hour Testing the Key to Success? Vol. 48, Diabetes Care. American Diabetes Association Inc.; 2025. p. 874-6.'}, {'type': 'BACKGROUND', 'citation': 'Buysschaert M, Bergman M, Valensi P. 1-h post-load plasma glucose for detecting early stages of prediabetes. Vol. 48, Diabetes and Metabolism. Elsevier Masson s.r.l.; 2022.'}, {'type': 'BACKGROUND', 'citation': 'Retnakaran R, Ye C, Kramer CK, Hanley AJ, Connelly PW, Sermer M, et al. One-Hour Oral Glucose Tolerance Test for the Postpartum Reclassification of Women With Hyperglycemia in Pregnancy. Diabetes Care. 2025 Jun 1;48(6):887-95.'}, {'type': 'BACKGROUND', 'citation': "McIntyre HD, Fuglsang J, Kampmann U, Knorr S, Ovesen P. Hyperglycemia in Pregnancy and Women's Health in the 21st Century. Vol. 19, International journal of environmental research and public health. NLM (Medline); 2022."}, {'type': 'BACKGROUND', 'citation': 'Bozkurt L, Göbl CS, Pfligl L, Leitner K, Bancher-Todesca D, Luger A, et al. Pathophysiological characteristics and effects of obesity in women with early and late manifestation of gestational diabetes diagnosed by the International Association of Diabetes and Pregnancy Study Groups criteria. Journal of Clinical Endocrinology and Metabolism. 2015 Mar 1;100(3):1113-20.'}, {'type': 'BACKGROUND', 'citation': 'Hod M, Kapur A, Sacks DA, Hadar E, Agarwal M, Di Renzo GC, et al. The International Federation of Gynecology and Obstetrics (FIGO) Initiative on gestational diabetes mellitus: A pragmatic guide for diagnosis, management, and care#. International Journal of Gynecology & Obstetrics [Internet]. 2015 Oct 1;131(S3):S173-211. Available from: https://doi.org/10.1016/S0020-7292(15)30033-3'}], 'seeAlsoLinks': [{'url': 'https://www.diabetesatlas.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Gestational diabetes mellitus (GDM) is one of the most common clinical conditions in pregnancy, with an increasing incidence due to the rise in overweight women and the postponement of motherhood. It is associated with perinatal complications and an increased risk of developing prediabetes and type 2 diabetes after delivery. Therefore, it is recommended that a 75g oral glucose tolerance test (OGTT-75g) be performed between 6 and 12 weeks postpartum. Despite its relevance, the rate of adherence to the test is low. Recent studies also indicate that measuring blood glucose one hour after the overload may be more sensitive than the traditional two-hour measurement in the early detection of dysglycemia. This study aims to evaluate strategies for qualifying the screening of metabolic changes in the postpartum period among women with GDM. The objectives are: (1) to analyze the impact of sending reminders via WhatsApp on the attendance rate for the 75g OGTT; and (2) to compare the frequency of prediabetes and diabetes diagnoses using two different diagnostic strategies applied to the same test-the traditional (fasting and 2-hour blood glucose) and the alternative (fasting and 1-hour blood glucose).', 'detailedDescription': 'Gestational diabetes is one of the most common complications during pregnancy. With the increase in obesity and overweight in the population, as well as the postponement of motherhood, its incidence has been steadily increasing.\n\nIt is associated with complications such as polyhydramnios, macrosomia, premature labor, fetal death, hypoglycemia, and neonatal respiratory distress. Given the increase in the incidence of gestational diabetes and its clinical and epidemiological importance, a better understanding of the disease can promote improved care and prevention of its complications.\n\nWomen diagnosed with gestational diabetes mellitus (GDM) are at increased risk of developing prediabetes and type 2 diabetes in the years following childbirth. For this reason, national and international guidelines recommend performing a 75g oral glucose tolerance test (OGTT-75g) in the postpartum period, usually between six and 12 weeks after delivery, as a strategy for reclassifying glycemic status and early identification of persistent metabolic changes.\n\nDespite the clinical relevance of the OGTT-75g in the follow-up of women with GDM, the rate of attendance for the test is notoriously low, especially in public health services. The reasons are multifactorial and include task overload in the postpartum period, logistical barriers, low risk perception, and the absence of systematic strategies to reinforce attendance. Simple interventions, such as sending reminders via electronic messages, have shown promise.\n\nConsidering the clinical and epidemiological relevance of GDM and these two complementary challenges-low attendance rates for screening and the diagnostic limitations of the current protocol-we propose two lines of investigation in this study:\n\n1. to evaluate the impact of sending reminders via WhatsApp on the return rate for performing the 75g OGTT in the postpartum period; and\n2. to compare the prevalence of glycemic changes identified by two different diagnostic strategies: the traditional one (fasting and two-hour blood glucose) and the new one (fasting and one-hour blood glucose). The results obtained may contribute to the qualification of care protocols and the prevention of adverse metabolic outcomes in women with a history of GDM.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of gestational diabetes mellitus, according to diagnostic criteria proposed by the IADPSG, namely:\n* initial fasting blood glucose ≥ 92mg/dL OR\n* 75g oral glucose tolerance test with fasting ≥ 92mg/dL or after 1h ≥ 180mg/dL or after 2h ≥ 153mg/dL Delivery performed at HC-FMUSP Scheduling of the 75g oral glucose tolerance test between 6 and 12 weeks after delivery Agreement with the informed consent form\n\nExclusion Criteria:\n\nWithdrawal of consent Failure to complete the TOTG exam due to vomiting (exclusion from analysis 2 only)'}, 'identificationModule': {'nctId': 'NCT07489456', 'briefTitle': 'Screening for Dysglycemia During Postpartum Period in Women With GDM', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Strategies for Improving the Detection of Dysglycemia in the Postpartum Period in Women With Gestational Diabetes: Electronic Reminders and New Diagnostic Criteria', 'orgStudyIdInfo': {'id': '95734326.5.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control Group (current practice): will not receive reminder messages for the exam.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Intervention Group: will receive automatic reminder messages via WhatsApp on days D-7 and D-3 in relation to the scheduled date for the exam. If the patient does not attend, she will receive a single additional message on the following business day, offering the possibility of rescheduling. Rescheduled exams will not receive new reminders. The message sent will contain a read receipt request to ensure that the patient has received the text. If the patient requests to reschedule the exam before the originally scheduled date, we will consider the new date as D for sending reminder messages.', 'interventionNames': ['Other: Whatsapp message']}], 'interventions': [{'name': 'Whatsapp message', 'type': 'OTHER', 'description': 'Automatic reminder messages via WhatsApp on days D-7 and D-3 in relation to the scheduled date for the exam.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05.403-905', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Tatiana A Zaccara, MD PhD', 'role': 'CONTACT', 'email': 'tatiana.assuncao@hc.fm.usp.br', 'phone': '+551126616209'}], 'facility': 'University of Sao Paulo General Hospital', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Tatiana A Zaccara, MD PhD', 'role': 'CONTACT', 'email': 'tatiana.assuncao@hc.fm.usp.br', 'phone': '+551126616209'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Tatiana Assunção Zaccara', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}