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
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Fetal; Circulation
• Persistent Fetal Circulation Syndrome
• Pregnancy Related

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