Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-30 @ 5:03 PM
Study NCT ID:
NCT07022158
Status:
COMPLETED
Last Update Posted:
2025-06-15
First Post:
2025-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antenatal Body Shape Index and Pregnancy Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2025-05-23', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calculation of body shape index at 6-16 weeks of gestation', 'timeFrame': '6-16 weeks of gestation', 'description': 'The study included pregnant women who applied to the Obstetrics and Gynecology outpatient clinic of Bolu Abant İzzet Baysal Training and Research Hospital between September 2023 and March 2024. During the first antenatal examination of the patients at 6-16 weeks of pregnancy, body shape indexes were calculated by measuring height, body weight and waist circumference.'}], 'secondaryOutcomes': [{'measure': 'Number of patients developing pregnancy complications', 'timeFrame': 'gestation period and first 6 weeks postpartum', 'description': 'Patients whose body shape index was calculated at 6-16 weeks of gestation were evaluated during pregnancy follow-up according to the development of Gestational Diabetes, Gestational Hypertension and Preeclampsia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gestational hypertension', 'gestational diabetes', 'preeclampsia', 'body shape index', 'waist circumference'], 'conditions': ['Gestational Complications', 'Body Mass Index', 'Waist Circumference', 'Gestational Hypertension', 'Gestational Diabetes Mellitus (GDM)', 'Preeclampsia (PE)']}, 'descriptionModule': {'briefSummary': 'Background/aim: Gestational diabetes (GDM), gestational hypertension (GHT) and preeclampsia are common complications of pregnancy. In this study, it was aimed to determine the relationship between body shape index (ABSI), calculated based on antenatal measurements of the height, weight and waist circumference, and GDM, GHT and preeclampsia.\n\nMaterials and methods: 170 patients at 6-16th weeks of gestation were prospectively analyzed. Body mass index (BMI) and ABSI were calculated. Patients were analyzed according to the presence of GDM, GHT and preeclampsia at follow-up.\n\nOur study is the first in terms of its subject and makes a significant contribution to the literature.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '170 patients at 6-16th weeks of gestation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a singleton pregnancy\n* Pregnancy follow-up and birth must have taken place at Bolu Abant İzzet Baysal University Training and Research Hospital.\n* Voluntary informed consent form must be signed to participate in the study.\n\nExclusion Criteria:\n\n* Multiple pregnancies\n* Additional systemic and chronic diseases (chronic hypertension, DM, hepatic diseases such as cholestasis, cardiac diseases, rheumatic diseases, renal diseases…)\n* History of Gestational Diabetes, Gestational Hypertension and Preeclampsia in previous pregnancies'}, 'identificationModule': {'nctId': 'NCT07022158', 'briefTitle': 'Antenatal Body Shape Index and Pregnancy Complications', 'organization': {'class': 'OTHER', 'fullName': 'Abant Izzet Baysal University'}, 'officialTitle': 'Relationship Between Antenatal Body Shape Index and Pregnancy Complications', 'orgStudyIdInfo': {'id': 'AbantIBU-elifbetulesmer-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': '184 pregnant women who applied to Bolu Abant İzzet Baysal Training and Research Hospital', 'interventionNames': ['Other: The patients participating in the study were between 6 and 16 weeks of pregnancy. Height, body weight, and waist circumference were measured at the first antenatal visit at 2 weeks.']}], 'interventions': [{'name': 'The patients participating in the study were between 6 and 16 weeks of pregnancy. Height, body weight, and waist circumference were measured at the first antenatal visit at 2 weeks.', 'type': 'OTHER', 'description': '170 patients at 6-16th weeks of gestation were prospectively analyzed. Body mass index (BMI) and ABSI were calculated. Patients were analyzed according to the presence of GDM, GHT and preeclampsia at follow-up.', 'armGroupLabels': ['184 pregnant women who applied to Bolu Abant İzzet Baysal Training and Research Hospital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14030', 'city': 'Bolu', 'country': 'Turkey (Türkiye)', 'facility': 'Abant Izzet Baysal University Faculty of Medicine, 14030, Bolu, Turkey', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abant Izzet Baysal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Obstetrics and Gynaecology Specialist', 'investigatorFullName': 'Elif Betul Esmer', 'investigatorAffiliation': 'Abant Izzet Baysal University'}}}}