Doppler Ultrasonographic Assessment of Fetal Internal Thoracic Artery Indexes

December 24, 2020 updated by: Betül Yakıştıran, Ankara City Hospital Bilkent
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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

healthy fetuses between 24th and 32nd gestational weeks

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: betül yakıştıran, MD, Ankara City Hospital Bilkent
  • Principal Investigator: aykan yücel, professor, Ankara City Hospital Bilkent
  • Principal Investigator: mihriban alkan, MD, Ankara City Hospital Bilkent
  • Principal Investigator: seval erdinç, assoc prof, ankara city hospitalBilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

December 24, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Actual)

December 28, 2020

Last Update Submitted That Met QC Criteria

December 24, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • internalthoracicarterydoppler

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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