Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-27 @ 7:42 PM
Study NCT ID:
NCT01833559
Status:
UNKNOWN
Last Update Posted:
2014-03-18
First Post:
2013-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Blood Glucose at the First Trimester of Pregnant Women With Gestational Diabetes on Maternal and Fetal Outcomes and Metabolic Disorders: a Multi-central Prospective Cohort Study
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': 'D007328', 'term': 'Insulin'}, {'id': 'D000068880', 'term': 'Isophane Insulin, Human'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007336', 'term': 'Insulin, Isophane'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061386', 'term': 'Insulin, Regular, Human'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-16', 'studyFirstSubmitDate': '2013-04-10', 'studyFirstSubmitQcDate': '2013-04-14', 'lastUpdatePostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The incidence of temporal and distant metabolic disorder of mother', 'timeFrame': '2 months to 1 year after delivery', 'description': 'After about 2 months after delivery when mother comes back for postpartum follow-up, some tests will be done, such as regular blood test,blood glucose(fasting and 2 hours after meal), urine regular test and so on.'}, {'measure': 'Child growth measures', 'timeFrame': '2 months to 1 year after delivery', 'description': "Children's body weight and height will be firstly recorded when their mothers come back for postpartum follow-ups at about 2 months after delivery by asking them or measure their children on the spot if they take their children with them.\n\nAnd the growth measures of children will be recorded for the second time by asking them via telephone at about 1 year after delivery."}], 'primaryOutcomes': [{'measure': 'The incidence of GDM at the second gestational trimester', 'timeFrame': 'at the second gestational trimester(about 24-28 gestational weeks)', 'description': 'The results of oral glucose tolerance test(OGTT) at the second gestational trimester(about 24-28 gestational weeks) which is used to diagnose GDM will be recorded to analysis the incidence of GDM at the second gestational trimester.'}], 'secondaryOutcomes': [{'measure': 'Gestational outcomes', 'timeFrame': 'After delivery', 'description': 'The adverse gestational outcomes will be recorded. For example: GDM, preeclampsia,fetal growth restriction(FGR),and so on.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gestational Diabetes']}, 'descriptionModule': {'briefSummary': 'The study is to investigate the impact of blood glucose management at the first trimester of pregnant women with gestational diabetes on the maternal and fetal outcomes and metabolic disorder.', 'detailedDescription': 'Gestational diabetes(GDM) is the glucose metabolic disorder that first diagnosed during pregnancy. With the development of social economy and the improvement of life, the incidence of GDM increases to a level of 18-20% year by year. High blood glucose has a strong relationship with many adverse maternal and fetal outcomes, but also influences their metabolism including the increase of susceptibility of maternal type 2 diabetes and risk of fetal type 2 diabetes, obesity, coronary heart disease, etc. And therefore, it is significant to screening and managing maternal blood glucose to prevent maternal and fetal adverse outcomes and metabolic disorder.\n\nThis multi-central prospective cohort study is supposed to study the pregnant women whose fasting blood glucose is slightly increased (between 5.1 mmol/L and 7.0 mmol/L) at the first gestational trimester. The aim of this study is to answer the scientific questions bellow: whether interventions to whom the blood glucose is slightly increased can\n\n1. decrease the incidence of GDM at the second gestational trimester;\n2. improve gestational outcomes;\n3. decrease the incidence of temporal and distant metabolic disorder of mother and her child.\n\nThe result will provide scientific evidence for improving the gestational outcomes of GDM women and preventing metabolic disorder of their child during adolescence and adult period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* regular antenatal examination from the first trimester;\n* accurate left mentoposterior(LMP) verified by ultrasonography(USG);\n* fasting blood glucose level between 5.1 mmol/L and 7.0 mmol/L.\n\nExclusion Criteria:\n\n* younger than 18 years old;\n* do not give birth in the research centers above;\n* LMP is undefined and lack of USG during 6-14 gestational weeks;\n* multiple pregnancy;\n* non-natural pregnancy(including intrauterine insemination(IUI), in-vitro fertilization and embryo transfer(IVF-ET), etc);\n* diagnosed DM before pregnancy;\n* with hepatitis B virus, hepatitis C virus, HIV infection;\n* taking drugs including glucocorticoid, diuretic, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker(ACEI/ARB), etc.\n* complicated with diseases that affect glucose metabolism such as hyperthyroidism and so on.'}, 'identificationModule': {'nctId': 'NCT01833559', 'briefTitle': 'Impact of Blood Glucose at the First Trimester of Pregnant Women With Gestational Diabetes on Maternal and Fetal Outcomes and Metabolic Disorders: a Multi-central Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Impact of Blood Glucose at the First Trimester of Pregnant Women With Gestational Diabetes on Maternal and Fetal Outcomes and Metabolic Disorders: a Multi-central Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'GDMTEST-5010-00'}, 'secondaryIdInfos': [{'id': 'GDMTEST-5010-01', 'type': 'REGISTRY', 'domain': 'Gynecology and obstetrics department of the 1st affiliated hospital of Sun Yat-sen University'}, {'id': 'GDMTEST-5010-02', 'type': 'REGISTRY', 'domain': 'Gynecology and obstetrics department of the 3rd affiliated hospital of Sun Yat-sen University'}, {'id': 'GDMTEST-5010-03', 'type': 'REGISTRY', 'domain': 'Guangdong women and children hospital'}, {'id': 'GDMTEST-5010-04', 'type': 'REGISTRY', 'domain': 'Guangzhou women and children hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Incidence of GDM', 'description': 'Dietary control will be suggested to patients if their fasting blood glucose is between 5.1 mmol/L and 7.0 mmol/L. If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized.', 'interventionNames': ['Dietary Supplement: Dietary control', 'Drug: Insulin']}, {'type': 'OTHER', 'label': 'Gestational outcomes', 'description': 'Dietary control will be suggested to patients if their fasting blood glucose is between 5.1 mmol/L and 7.0 mmol/L. If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized.', 'interventionNames': ['Dietary Supplement: Dietary control', 'Drug: Insulin']}, {'type': 'OTHER', 'label': 'Metabolic disorder', 'description': 'Dietary control will be suggested to patients if their fasting blood glucose is between 5.1 mmol/L and 7.0 mmol/L. If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized.', 'interventionNames': ['Dietary Supplement: Dietary control', 'Drug: Insulin']}], 'interventions': [{'name': 'Dietary control', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Gestational outcomes', 'Incidence of GDM', 'Metabolic disorder']}, {'name': 'Insulin', 'type': 'DRUG', 'otherNames': ['Novolin R', 'Novolin N', 'Novolin 30R', 'Novolin 50R'], 'description': 'If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized and insulin will be used. The kind of insulin used depends on the need of patients.', 'armGroupLabels': ['Gestational outcomes', 'Incidence of GDM', 'Metabolic disorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zilian Wang, Doctor', 'role': 'CONTACT', 'email': 'zilianwang@gmail.com', 'phone': '13602885248', 'phoneExt': '+86'}, {'name': 'Zilian Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gynecology and obstetrics department of the 1st affiliated hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Zilian Wang, Doctor', 'role': 'CONTACT', 'email': 'zilianwang@gmail.com', 'phone': '13602885248', 'phoneExt': '+86'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Zilian Wang', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}