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ObeseNCT04638504

Comparison of Brachial Artery Dilatation, Uterine Artery Doppler, Umbilical Artery Doppler and 1st-trimester Visceral Adipose Tissue Measurement in Obese and Normal Pregnant Women

An observational study of Obese and Vascular Diseases, run by Diyarbakir Women's and Children's Diseases Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Obese, Vascular Diseases, Pregnancy Related
What is being tested?
ultrasonography
How many people
240 participants
Where
1 siteTurkey (Türkiye)
Study dates
19 Nov 2020to 27 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Adult

Study population: 240

Who may be able to join

  • obese and normal pregnant
  • 11-14 weeks
  • 24-28 weeks
  • 37-40 weeks

Who cannot join

  • smoking
  • chronic vascular disease
  • Diabetes mellitus
  • Over 40 years old

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Diyarbakır Women's and Children's Hospital

    Diyarbakır, 21100

Other trials in Turkey (Türkiye)

About this study

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

Read the 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.

Being tested
ultrasonography
Medical subject headings
Obesity, Vascular Diseases, Obesity, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ultrasonographyOther

    vascular and adipose tissue measurement by ultrasonography

Study groups in NCT04638504
Study groupRoleWhat they receive
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.
Receives: Other: ultrasonography
11-14 week obese pregnant11-14. 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.
Receives: Other: ultrasonography
24-28 week normal pregnant24-28. Measurement of brachial artery flow dilatation in the arm during pregnancy weeks, fetal umbilical artery, and maternal uterine artery dopes will be examined ultrasonographically.
Receives: Other: ultrasonography
24w-28w obese normal pregnant24w-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
Receives: Other: ultrasonography
37w -40w normal pregant37w-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
Receives: Other: ultrasonography
37-40 w obese normal pregnant37w-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
Receives: Other: ultrasonography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 month

  2. Measurement of uterine artery doppler in obese and normal pregnant women

    To determine whether obesity has an effect on uterine artery resistance.

    Measured: 3 month

  3. 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,

    Measured: 3 month

  4. 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

    Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2020
  2. Study start19 Nov 2020
  3. Primary completion27 Feb 2021
  4. Study completion27 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04638504
Sponsor's protocol ID
DiyarbakirWCDH 3
Status last verified
Feb 2021
First submitted
18 Oct 2020
Last updated
2 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 21480285

  • 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.

    PubMed 14504628

  • 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.

    PubMed 16527277

  • 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.

    PubMed 25476264

  • 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.

    PubMed 19282819

Questions about this trial

What is this clinical trial studying?

An observational study of Obese and Vascular Diseases, run by Diyarbakir Women's and Children's Diseases Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To define the relationship between obesity and endovascular dysfunction by brachial artery dilatation method. (time frame: 3 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04638504, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.

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