NCT04686240

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

December 22, 2020

Last Update Submit

December 24, 2020

Conditions

Pregnancy RelatedFetal; Circulation

Outcome Measures

Primary Outcomes (2)

  • Doppler indices for internal thoracic artery

    Doppler indices (pulsatility index, resistance index, acceleration and ejection time)

    Between 24th and 32nd gestational weeks

  • assessment of fetal thymus size

    volume and perimeter and transvers diameter

    Between 24th and 32nd gestational weeks

Eligibility Criteria

Age17 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy fetuses between 24th and 32nd gestational weeks

You may qualify if:

  • singleton pregnancy
  • having no fetal anomalies
  • healthy pregnant women age \>17 and \<45 years
  • between 24th-32nd gestational weeks

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

betül yakıştıran, MD

CONTACT

+905464296321btlengin@gmail.com

aykan yücel, professor

CONTACT

+905323851110aykanyucel@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 28, 2020

Study Start

January 1, 2021

Primary Completion

April 1, 2021

Study Completion

June 1, 2021

Last Updated

December 28, 2020

Record last verified: 2020-12