Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-28 @ 7:28 AM
Study NCT ID:
NCT03330951
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2016-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Control and Iron Status in Diabetic Pregnancies - a Study of New Markers
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-24', 'studyFirstSubmitDate': '2016-11-17', 'studyFirstSubmitQcDate': '2017-11-02', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic Control markers in pregnancy', 'timeFrame': 'throughout pregnancy, gestational week 12-36.', 'description': 'Compare HbA1c and glycated albumin to blood sugar measurements'}], 'secondaryOutcomes': [{'measure': 'Iron status in diabetic pregnancy,', 'timeFrame': 'throughout pregnancy, gestational week 12-36.', 'description': 'Compare current markers of iron status with hepcidin throghout diabetic pregnancies by analyses of blood samples in gestational week 12, 20, 24, 28, 32 and 36.'}, {'measure': 'Preterm delivery', 'timeFrame': 'at delivery.', 'description': 'Register pregnancy outcomes. Delivery before gestational week 37 will be registered. Data will be collected from journals.'}, {'measure': 'Preeclampsia', 'timeFrame': 'From gestational week 20 to 1 week after delivery.', 'description': 'Register pregnancy outcomes. New onset systolic blood pressure \\>140, diastolic blood pressure \\>90 after gestational week 20 and proteinuria 2+ according to urine dipstick, will be registered as preeclampsia'}, {'measure': 'Induction of labour', 'timeFrame': 'At delivery.', 'description': 'Register pregnancy outcome. Induction of Labour and indication for induction will be registered.'}, {'measure': 'APGAR', 'timeFrame': 'At delivery.', 'description': 'Register pregnancy outcome. APGAR score (Appearance, Pulse, Grimace, Activity, Respiration) of the newborn will be registered for 1 minute, 5 minute and 10 minutes after delivery.'}, {'measure': 'Birth weight', 'timeFrame': 'At delivery.', 'description': 'Register pregnancy outcome. Birth weight (gram) of the newborn will be registered.'}, {'measure': 'Admission to neonatal intensive care unit', 'timeFrame': 'At delivery.', 'description': 'Register pregnancy outcome. Admission to neonatal intensive care unit will be registered.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HbA1c', 'Glycated albumin'], 'conditions': ['Diabetes Mellitus Pregnancy']}, 'descriptionModule': {'briefSummary': "This is an observational study at the Obstetrical outpatient clinic at Stavanger University Hospital. The main goal is to compare the current marker of glycemic control (glycated hemoglobin A1c, HbA1c) with glycated albumin in pregnancies with pregestational diabetes mellitus.\n\nWomen with diabetes are at increased risk for adverse pregnancy outcomes. With improved glycemic control, the risk decreases. Glycated albumin is suggested to be a better marker for monitoring glycemic control in pregnancies because it reflects blood glucose for a shorter period than HbA1c (3 versus 8-12 weeks). Other studies have shown that HbA1c increases in pregnancy because of iron deficiency. The investigators want to investigate HbA1c, glycated albumin and iron status in diabetic pregnancies. The investigators will compare HbA1c and glycated albumin throughout pregnancy with the patient's own blood glucose measurements or data from CGM (continuous blood glucose monitoring). Blood samples for HbA1c and glycated albumin will be taken 6 times during pregnancy (week 12, 20, 24, 28, 32, 36)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women with pregestational diabetes mellitus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregestational diabetes mellitus\n* singleton pregnancy\n* follow-up at Stavanger University Hospital in pregnancy\n\nExclusion Criteria:\n\n* gestational diabetes\n* twin pregnancies'}, 'identificationModule': {'nctId': 'NCT03330951', 'briefTitle': 'Glycemic Control and Iron Status in Diabetic Pregnancies - a Study of New Markers', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Helse Stavanger HF'}, 'officialTitle': 'Glycemic Control and Iron Status in Diabetic Pregnancies - a Study of New Markers', 'orgStudyIdInfo': {'id': 'SUS-ID580'}}, 'contactsLocationsModule': {'locations': [{'zip': '4068', 'city': 'Stavanger', 'state': 'Rogaland', 'country': 'Norway', 'facility': 'Stavanger University Hospital', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}], 'overallOfficials': [{'name': 'Johanne Toft, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helse Stavanger HF'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}