NCT04638504

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

November 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2021

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

October 18, 2020

Last Update Submit

February 27, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • Measurement of uterine artery doppler in obese and normal pregnant women

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

    3 month

  • 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

  • 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

Study Arms (6)

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.

Other: 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.

Other: 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.

Other: 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

Other: 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

Other: 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

Other: ultrasonography

Interventions

vascular and adipose tissue measurement by ultrasonography

11-14 week obese pregnant11-14 weeks of normal pregnancy.24-28 week normal pregnant24w-28w obese normal pregnant37-40 w obese normal pregnant37w -40w normal pregant

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

240

You may qualify if:

  • obese and normal pregnant
  • weeks
  • weeks
  • weeks

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diyarbakır Women's and Children's Hospital

Diyarbakır, 21100, Turkey (Türkiye)

Location

Related 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.

    PMID: 21480285BACKGROUND
  • 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: 14504628BACKGROUND
  • 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: 16527277BACKGROUND
  • 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: 25476264BACKGROUND
  • 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.

    PMID: 19282819BACKGROUND

MeSH Terms

Conditions

ObesityVascular DiseasesObesity, Abdominal

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Şeyhmus Tunç, MD

    Diyarbakır Gynecology Maternity and Pediatrics Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of medicine

Study Record Dates

First Submitted

October 18, 2020

First Posted

November 20, 2020

Study Start

November 19, 2020

Primary Completion

February 27, 2021

Study Completion

February 27, 2021

Last Updated

March 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations