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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04638504
Other study ID # DiyarbakirWCDH 3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 19, 2020
Est. completion date February 27, 2021

Study information

Verified date February 2021
Source Diyarbakir Women's and Children's Diseases Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Brachial artery flow-mediated in obese and normal-weight pregnant women dilation of uterine artery doppler and umbilical artery doppler results comparison of


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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date February 27, 2021
Est. primary completion date February 27, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Intervention

Other:
ultrasonography
vascular and adipose tissue measurement by ultrasonography

Locations

Country Name City State
Turkey Diyarbakir Women's and Children's Hospital Diyarbakir

Sponsors (1)

Lead Sponsor Collaborator
Diyarbakir Women's and Children's Diseases Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

Oliveira OP, Araujo Júnior 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. — View 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. — View Citation

Sierra-Laguado J, Garcia RG, López-Jaramillo P. Flow-mediated dilatation of the brachial artery in pregnancy. Int J Gynaecol Obstet. 2006 Apr;93(1):60-1. Epub 2006 Mar 9. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To define the relationship between obesity and endovascular dysfunction by brachial artery dilatation method. To examine the possible effects of obesity on the endovascular system with the brachial artery dilation method. 3 month
Primary Measurement of uterine artery doppler in obese and normal pregnant women To determine whether obesity has an effect on uterine artery resistance. 3 month
Primary Measurement of obese and normal pregnant umbilical artery doppler trying to understand whether obesity has fetal effects by examining umbilical artery doppler in obese pregnants and normal pregnants, 3 month
Primary First trimester visceral adipose tissue and brachial artery measurement 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
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