Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT04638504
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2020-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Brachial Artery Dilatation, Uterine Artery Doppler, Umbilical Artery Doppler and 1st-trimester Visceral Adipose Tissue Measurement in Obese and Normal Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}], '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'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-27', 'studyFirstSubmitDate': '2020-10-18', 'studyFirstSubmitQcDate': '2020-11-19', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To define the relationship between obesity and endovascular dysfunction by brachial artery dilatation method.', 'timeFrame': '3 month', 'description': 'To examine the possible effects of obesity on the endovascular system with the brachial artery dilation method.'}, {'measure': 'Measurement of uterine artery doppler in obese and normal pregnant women', 'timeFrame': '3 month', 'description': 'To determine whether obesity has an effect on uterine artery resistance.'}, {'measure': 'Measurement of obese and normal pregnant umbilical artery doppler', 'timeFrame': '3 month', 'description': 'trying to understand whether obesity has fetal effects by examining umbilical artery doppler in obese pregnants and normal pregnants,'}, {'measure': 'First trimester visceral adipose tissue and brachial artery measurement', 'timeFrame': '3 month', 'description': 'By measuring the amount of visceral tissue in the first trimester obese and normal pregnant women with Armellini method; Investigation of its effects on endovascular dysfunction through brachial artery dilatation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obese', 'Vascular Diseases', 'Pregnancy Related', 'Visceral Obesity']}, 'referencesModule': {'references': [{'pmid': '21480285', 'type': 'BACKGROUND', 'citation': 'Adali E, Kurdoglu M, Adali F, Cim N, Yildizhan R, Kolusari A. The relationship between brachial artery flow-mediated dilatation, high sensitivity C-reactive protein, and uterine artery doppler velocimetry in women with pre-eclampsia. J Clin Ultrasound. 2011 May;39(4):191-7. doi: 10.1002/jcu.20781. Epub 2010 Dec 28.'}, {'pmid': '14504628', 'type': 'BACKGROUND', 'citation': 'Takase B, Goto T, Hamabe A, Uehata A, Kuroda K, Satomura K, Ohsuzu F, Kurita A. Flow-mediated dilation in brachial artery in the second half of pregnancy and prediction of pre-eclampsia. J Hum Hypertens. 2003 Oct;17(10):697-704. doi: 10.1038/sj.jhh.1001599.'}, {'pmid': '16527277', 'type': 'BACKGROUND', 'citation': 'Sierra-Laguado J, Garcia RG, Lopez-Jaramillo P. Flow-mediated dilatation of the brachial artery in pregnancy. Int J Gynaecol Obstet. 2006 Apr;93(1):60-1. doi: 10.1016/j.ijgo.2006.01.015. Epub 2006 Mar 9. No abstract available.'}, {'pmid': '25476264', 'type': 'BACKGROUND', 'citation': 'Oliveira OP, Araujo Junior E, Lima JW, Salustiano EM, Ruano R, Martins WP, Costa Fda S. Flow-mediated dilation of brachial artery and endothelial dysfunction in pregnant women with preeclampsia: a case control study. Minerva Ginecol. 2015 Aug;67(4):307-13. Epub 2014 Dec 5.'}, {'pmid': '19282819', 'type': 'BACKGROUND', 'citation': "Parikh NI, Keyes MJ, Larson MG, Pou KM, Hamburg NM, Vita JA, O'Donnell CJ, Vasan RS, Mitchell GF, Hoffmann U, Fox CS, Benjamin EJ. Visceral and subcutaneous adiposity and brachial artery vasodilator function. Obesity (Silver Spring). 2009 Nov;17(11):2054-9. doi: 10.1038/oby.2009.60. Epub 2009 Mar 12."}]}, 'descriptionModule': {'briefSummary': 'Brachial artery flow-mediated in obese and normal-weight pregnant women dilation of uterine artery doppler and umbilical artery doppler results comparison of', 'detailedDescription': 'The systemic inflammatory effect caused by obesity and vascular disorder It has been reported that it creates studies. Healthy Vascular Endothelial structure increases vascular tone by regulating nitric oxide (NO) release. Reduced nitric oxide production, reducing flexibility It has a facilitating effect on hypertensive diseases and other obstetric diseases.\n\nEndothelial function, which is a non-invasive, easily applicable, and reproducible method It can be detected by endothelium-dependent vasodilation. A good indicator of endothelial function in studies in which the brachial artery flow-mediated dilation (FMD) shown. Brachial artery blood pressure cuff at forearm level in normal healthy people with compression for 3-5 minutes 50 mmHg above systolic pressure, 60-120 seconds after loosening the cuff When measured later, individuals with healthy endovascular function and the brachial artery are also reactive hyperemia, and a 10% dilatation is expected. Many obstetric effects such as obesity preeclampsia, preterm labor, gestational diabetes, preterm labor Although it was found to be related to pathology, the relationship between them could not be determined exactly.\n\nOur study aimed to increase brachial artery dilatation in obese and normal pregnant women.\n\nBy comparing, determine the level of nitric oxide and endovascular function. Also uterine Vascular structures of obesity by comparing vascular structures with artery and umbilical uterine dops examine the effect on\n\nPregnant women between the ages of 18-40 who apply to the Diseases and Obstetrics outpatient clinic will be taken. 24-28. Brachial artery dilatation, uterine, and umbilical artery doppler between 11-14, 37-40w weeks between gestational weeks, and visceral adipose tissue measurement at first trimester will be examined.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '240', 'genderDescription': 'pregnant', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obese and normal pregnant\n* 11-14 weeks\n* 24-28 weeks\n* 37-40 weeks\n\nExclusion Criteria:\n\n* smoking\n* chronic vascular disease\n* Diabetes mellitus\n* Over 40 years old'}, 'identificationModule': {'nctId': 'NCT04638504', 'briefTitle': 'Comparison of Brachial Artery Dilatation, Uterine Artery Doppler, Umbilical Artery Doppler and 1st-trimester Visceral Adipose Tissue Measurement in Obese and Normal Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': "Diyarbakir Women's and Children's Diseases Hospital"}, 'officialTitle': 'Comparison of Brachial Artery Dilatation, Uterine Artery Doppler, Umbilical Artery Doppler and 1st-trimester Visceral Adipose Tissue Measurement in Obese and Normal Pregnant Women', 'orgStudyIdInfo': {'id': 'DiyarbakirWCDH 3'}}, 'armsInterventionsModule': {'armGroups': [{'label': '11-14 weeks of normal pregnancy.', 'description': '11-14. Measurement of brachial artery flow dilatation in the arm during pregnancy weeks, Visceral adipose tissue measurement (armellini method), and maternal uterine artery dopes will be examined ultrasonographically.', 'interventionNames': ['Other: ultrasonography']}, {'label': '11-14 week obese pregnant', 'description': '11-14. Measurement of brachial artery flow dilatation in the arm during pregnancy weeks, Visceral adipose tissue measurement (armellini method), and maternal uterine artery dopes will be examined ultrasonographically.', 'interventionNames': ['Other: ultrasonography']}, {'label': '24-28 week normal pregnant', 'description': '24-28. Measurement of brachial artery flow dilatation in the arm during pregnancy weeks, fetal umbilical artery, and maternal uterine artery dopes will be examined ultrasonographically.', 'interventionNames': ['Other: ultrasonography']}, {'label': '24w-28w obese normal pregnant', 'description': '24w-28w. Measurement of brachial artery flow dilatation in the arm during pregnancy weeks, fetal umbilical artery and maternal uterine artery dopes will be examined ultrasonographically', 'interventionNames': ['Other: ultrasonography']}, {'label': '37w -40w normal pregant', 'description': '37w-40 w. Measurement of brachial artery flow dilatation in the arm during pregnancy weeks, fetal umbilical artery and maternal uterine artery dopes will be examined ultrasonographically', 'interventionNames': ['Other: ultrasonography']}, {'label': '37-40 w obese normal pregnant', 'description': '37w-40 w. Measurement of brachial artery flow dilatation in the arm during pregnancy weeks, fetal umbilical artery and maternal uterine artery dopes will be examined ultrasonographically', 'interventionNames': ['Other: ultrasonography']}], 'interventions': [{'name': 'ultrasonography', 'type': 'OTHER', 'description': 'vascular and adipose tissue measurement by ultrasonography', 'armGroupLabels': ['11-14 week obese pregnant', '11-14 weeks of normal pregnancy.', '24-28 week normal pregnant', '24w-28w obese normal pregnant', '37-40 w obese normal pregnant', '37w -40w normal pregant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21100', 'city': 'Diyarbakır', 'country': 'Turkey (Türkiye)', 'facility': "Diyarbakır Women's and Children's Hospital", 'geoPoint': {'lat': 37.91363, 'lon': 40.21721}}], 'overallOfficials': [{'name': 'Şeyhmus Tunç, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Diyarbakır Gynecology Maternity and Pediatrics Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Diyarbakir Women's and Children's Diseases Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor of medicine', 'investigatorFullName': 'Şerif AKSİN', 'investigatorAffiliation': "Diyarbakir Women's and Children's Diseases Hospital"}}}}