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NCT04686240 Clinical Trial

Doppler Ultrasonographic Assessment of Fetal Internal Thoracic Artery Indexes

Pregnancy Related Clinical Trial

Official title:
Doppler Ultrasonographic Assessment of Fetal Internal Thoracic Artery Indexes

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04686240
Other study ID # internalthoracicarterydoppler
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2021
Est. completion date June 2021

Study information
Verified date December 2020
Source Ankara City Hospital Bilkent
Contact betül yakistiran, MD
Phone +905464296321
Email btlengin@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to assess the feasibility of visualizing the internal thoracic artery (ITA), establishing the normogram for ITA pulsatility index (PI), resistance index (RI) and acceleration/ejection time (AT/ET) at 24-32 weeks.

Description:

Background: The internal thoracic artery arises from the subclavian artery as the first branch. It travels downward on the inside of the rib cage and then gives off six main branches; mediastinal, thymic, pericardiacophrenic, sternal, perforating and intercostal branches. In literature, there are so many articles that have been focused on thymus size in pregnancies complicated with diabetes mellitus, fetal growth restriction, preterm rupture of membranes and so on. To the best of our knowledge, there is no paper about fetal ITA whose branch are feeding vessel of thymus and ITA Doppler velocity. The arteries supplying the thymus are branches of the internal thoracic, and inferior thyroid arteries. As far as it has been known, growing of a tissue depends on increased blood flow. Before detecting possible blood-flow changes in fetuses complicated with great obstetrics patologies, the investigators should obtain normal values of ITA Doppler velocity.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date June 2021
Est. primary completion date April 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 17 Years to 45 Years
Eligibility Inclusion Criteria: - singleton pregnancy - having no fetal anomalies - healthy pregnant women age >17 and <45 years - between 24th-32nd gestational weeks Exclusion Criteria: - fetuses with congenital aneuploidy or structural malformation - underlying chronic diseases - pregnant women complicated with gestational diabetes, Type 1-2 DM, hypertension (pregnancy-induced; chronic; preeclampsia), malignancy - pregnancy complicated with preterm premature rupture of membranes, preterm labour, fetal growth restriction and another obstetric complication

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Outcome
Type Measure Description Time frame Safety issue
Primary Doppler indices for internal thoracic artery Doppler indices (pulsatility index, resistance index, acceleration and ejection time) Between 24th and 32nd gestational weeks
Primary assessment of fetal thymus size volume and perimeter and transvers diameter Between 24th and 32nd gestational weeks
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