Doppler Ultrasonographic Assessment of Fetal Internal Thoracic Artery Indexes

NCT ID: NCT04686240

Last Updated: 2020-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-31

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Related Fetal; Circulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

17 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Betül Yakıştıran

specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

betül yakıştıran, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

aykan yücel, professor

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

mihriban alkan, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

seval erdinç, assoc prof

Role: PRINCIPAL_INVESTIGATOR

ankara city hospitalBilkent

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

betül yakıştıran, MD

Role: CONTACT

Phone: +905464296321

Email: [email protected]

aykan yücel, professor

Role: CONTACT

Phone: +905323851110

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

internalthoracicarterydoppler

Identifier Type: -

Identifier Source: org_study_id