- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04638504
Comparison of Brachial Artery Dilatation, Uterine Artery Doppler, Umbilical Artery Doppler and 1st-trimester Visceral Adipose Tissue Measurement in Obese and Normal Pregnant Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Endothelial 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.
Our study aimed to increase brachial artery dilatation in obese and normal pregnant women.
By 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
Pregnant 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Diyarbakır, Turkey, 21100
- Diyarbakır Women's and Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- obese and normal pregnant
- 11-14 weeks
- 24-28 weeks
- 37-40 weeks
Exclusion Criteria:
- smoking
- chronic vascular disease
- Diabetes mellitus
- Over 40 years old
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
11-14 weeks of normal pregnancy.
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.
|
vascular and adipose tissue measurement by ultrasonography
|
11-14 week obese pregnant
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.
|
vascular and adipose tissue measurement by ultrasonography
|
24-28 week normal pregnant
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.
|
vascular and adipose tissue measurement by ultrasonography
|
24w-28w obese normal pregnant
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
|
vascular and adipose tissue measurement by ultrasonography
|
37w -40w normal pregant
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
|
vascular and adipose tissue measurement by ultrasonography
|
37-40 w obese normal pregnant
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
|
vascular and adipose tissue measurement by ultrasonography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To define the relationship between obesity and endovascular dysfunction by brachial artery dilatation method.
Time Frame: 3 month
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To examine the possible effects of obesity on the endovascular system with the brachial artery dilation method.
|
3 month
|
Measurement of uterine artery doppler in obese and normal pregnant women
Time Frame: 3 month
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To determine whether obesity has an effect on uterine artery resistance.
|
3 month
|
Measurement of obese and normal pregnant umbilical artery doppler
Time Frame: 3 month
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trying to understand whether obesity has fetal effects by examining umbilical artery doppler in obese pregnants and normal pregnants,
|
3 month
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First trimester visceral adipose tissue and brachial artery measurement
Time Frame: 3 month
|
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
|
3 month
|
Collaborators and Investigators
Investigators
- Study Director: Şeyhmus Tunç, MD, Diyarbakır Gynecology Maternity and Pediatrics Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DiyarbakirWCDH 3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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