Pregnancy RelatedNCT04686240
Doppler Ultrasonographic Assessment of Fetal Internal Thoracic Artery Indexes
An observational study of Pregnancy Related and Fetal; Circulation, run by Ankara City Hospital Bilkent.
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. Read more about this study
- Who is it for?
- Ages 17 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Fetal; Circulation
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: healthy fetuses between 24th and 32nd gestational weeks
Who may be able to join
- singleton pregnancy
- having no fetal anomalies
- healthy pregnant women age >17 and <45 years
- between 24th-32nd gestational weeks
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Pregnancy Related, Fetal; Circulation
- Medical subject headings
- Persistent Fetal Circulation Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Doppler indices for internal thoracic artery
Doppler indices (pulsatility index, resistance index, acceleration and ejection time)
Measured: Between 24th and 32nd gestational weeks
assessment of fetal thymus size
volume and perimeter and transvers diameter
Measured: Between 24th and 32nd gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Yakıştıran, Ankara City Hospital Bilkent
- Investigators
- betül yakıştıran, MD, Principal investigator, Ankara City Hospital Bilkentaykan yücel, professor, Principal investigator, Ankara City Hospital Bilkentmihriban alkan, MD, Principal investigator, Ankara City Hospital Bilkentseval erdinç, assoc prof, Principal investigator, ankara city hospitalBilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686240
- Sponsor's protocol ID
- internalthoracicarterydoppler
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doppler Ultrasonographic Assessment of Fetal Internal Thoracic Artery Indexes
- ClinicalTrials.gov ID
- NCT04686240
- Acronym / sponsor ID
- internalthoracicarterydoppler
- Conditions
- Pregnancy Related, Fetal; Circulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- healthy fetuses between 24th and 32nd gestational weeks
Key inclusion criteria (4 listed)
- singleton pregnancy
- having no fetal anomalies
- healthy pregnant women age >17 and <45 years
- between 24th-32nd gestational weeks
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Doppler indices for internal thoracic artery
Time frame: Between 24th and 32nd gestational weeks
Doppler indices (pulsatility index, resistance index, acceleration and ejection time)
assessment of fetal thymus size
Time frame: Between 24th and 32nd gestational weeks
volume and perimeter and transvers diameter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
betül yakıştıran, MD principal investigator
Ankara City Hospital Bilkent
aykan yücel, professor principal investigator
Ankara City Hospital Bilkent
mihriban alkan, MD principal investigator
Ankara City Hospital Bilkent
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Fetal; Circulation, run by Ankara City Hospital Bilkent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact betül yakıştıran, MD (+905464296321, btlengin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Doppler indices for internal thoracic artery (time frame: Between 24th and 32nd gestational weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2020.