Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-04 @ 3:44 AM
Study NCT ID:
NCT02564250
Status:
UNKNOWN
Last Update Posted:
2015-09-30
First Post:
2015-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-29', 'studyFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2015-09-29', 'lastUpdatePostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mode of delivery', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Longitudinal metabolic changes during pregnancy', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pregnancy', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study longitudinal changes in maternal metabolism and pregnancy outcomes in obese pregnant women.', 'detailedDescription': 'We will study how normal metabolic changes of pregnancy are modified in obesity and investigate the consequences of altered fat and carbohydrate metabolism for pregnancy outcome. The results will aid our understanding of why pregnant obese women and their babies are at higher risk of complications and may highlight potential therapies to reduce these risks.\n\nOverall aim and hypothesis:\n\nThe overall aim is to increase knowledge about the relation between obesity, metabolic profile/risk factors and pregnancy outcome in order to improve antenatal care and the health of the next generation.\n\nWe hypothesize that obese pregnant women can be differentiated into subgroups according to their metabolic risk profile and their risk of adverse pregnancy outcomes.\n\nSpecific aims:\n\nEstablish an outpatient clinic for obese pregnant women at Department of Obstetrics, Drammen, Vestre Viken HF in order to:\n\n* Provide improved antenatal care for obese pregnant women who have increased risk of pregnancy complications by offering:\n\n * antenatal care according to national guidelines (Veileder i fødselshjelp 2014)\n * fetal surveillance (ultrasound)\n * planned delivery according to national and local guidelines\n* Conduct an observational study in which clinical and biochemical data will be collected in order to increase knowledge on longitudinal metabolic changes in pregnancies complicated by obesity and how these relate to pregnancy outcomes'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women with prepregnancy BMI \\> 35', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women with pregestational BMI \\> 35\n\nExclusion Criteria:\n\n* diabetes mellitus type 1'}, 'identificationModule': {'nctId': 'NCT02564250', 'briefTitle': 'Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Vestre Viken Hospital Trust'}, 'officialTitle': 'Healthy Mother - Lifelong Health: A Longitudinal Study on Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women', 'orgStudyIdInfo': {'id': 'REK 2015/1017'}}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Drammen', 'state': 'Buskerud', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Jeanette Koht, Phd', 'role': 'CONTACT', 'email': 'uxjeko@vestreviken.no', 'phone': '91632024'}, {'name': 'Marie Cecilie P Roland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vestre Viken Hospital Trust', 'geoPoint': {'lat': 59.74389, 'lon': 10.20449}}], 'centralContacts': [{'name': 'Bjørn Rishovd Rund, PhD', 'role': 'CONTACT', 'email': 'mailto:BjornRishovd.Rund@vestreviken.no', 'phone': '+4732800000'}], 'overallOfficials': [{'name': 'Marie Cecilie P Roland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vestre Viken HF'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vestre Viken Hospital Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}