Fetal Heart Echocardiography by Five Dimensional UltrasoundNCT02643199
Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy
An observational study of Fetal Heart Echocardiography by Five Dimensional Ultrasound, run by Ain Shams University.
Trial summary
The aim of the study to evaluate Five-Dimensional Ultrasound in automated assessment of the fetal heart from 20-36 weeks of gestation. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Heart Echocardiography by Five Dimensional Ultrasound
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Sep 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital. Ninety pregnant women will be recruited from the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.
Who may be able to join
- Singleton pregnancy.
- Gestational age at 34-36 weeks as determined be date and last menstrual period.
- Normal Amniotic Fluid Index.
Who cannot join
- Multiple pregnancies.
- Oligohydramnios or Polyhydramnios (AFI > 95th percentile or < 5th percentile).
- Obese patient, BMI > 30
- Intrauterine growth restriction.
- Fetal spine between the 11- and 1- O'clock positions due to possibility of shadowing from ribs or spine
About this study
The aim of the study to evaluate Five-Dimensional Ultrasound in automated assessment of the fetal heart from 20-36 weeks of gestation.
Read the detailed description
This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.
90 pregnant women will be recruited from the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.
All cases will be subjected to:
- Full history taking including patient's age, parity, last menstrual period, estimated gestational age by dates, past history of medical disorders, clinical examinations (General and abdominal).
- Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be done for all cases for assessment of fetal Heart.
- 90 consecutive patients will undergo 2D fetal echocardiography by one observer
- Then they will undergo blindly Five-Dimensional fetal echocardiography by another observer
- The data collected will be compared to evaluate the accuracy of Five-Dimensional US in fetal heart assessment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound
Fetal Echocardiography by Two-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views:
- Four chamber view
- Five chamber view
- Left outflow tract
- Right outflow tract
- 3 vessels and Trachea View
- Abdomen/Stomach
- Ductal arch
- aortic arch
- Bicaval view then we count howmuch views of nine views were satisfactory
Measured: 20 - 36 weeks of gestation
Secondary outcomes (1)
Number of Satisfactory Fetal Echocardiography Views by Five-Dimensional Ultrasound
Fetal Echocardiography by Five-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views:
- Four chamber view
- Five chamber view
- Left outflow tract
- Right outflow tract
- 3 vessels and Trachea View
- Abdomen/Stomach
- Ductal arch
- aortic arch
- Bicaval view then we count howmuch views of nine views were satisfactory
Measured: 20 - 36 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fetal Heart Echocardiography by Five Dimensional UltrasoundStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Mohamed Abdelrahman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643199
- Sponsor's protocol ID
- 5D Echocardiography
- Status last verified
- Jun 2017
- First submitted
- 28 Dec 2015
- Last updated
- 14 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT02643199
- Acronym / sponsor ID
- 5D Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Posted 16 Jun 2017
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 the study to evaluate Five-Dimensional Ultrasound in automated assessment of the fetal heart from 20-36 weeks of gestation.
Detailed description
This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.
90 pregnant women will be recruited from the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.
All cases will be subjected to:
- Full history taking including patient's age, parity, last menstrual period, estimated gestational age by dates, past history of medical disorders, clinical examinations (General and abdominal).
- Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be done for all cases for assessment of fetal Heart.
- 90 consecutive patients will undergo 2D fetal echocardiography by one observer
- Then they will undergo blindly Five-Dimensional fetal echocardiography by another observer
- The data collected will be compared to evaluate the accuracy of Five-Dimensional US in fetal heart assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital. Ninety pregnant women will be recruited from the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.
Key inclusion criteria (3 listed)
- Singleton pregnancy.
- Gestational age at 34-36 weeks as determined be date and last menstrual period.
- Normal Amniotic Fluid Index.
Key exclusion criteria (5 listed)
- Multiple pregnancies.
- Oligohydramnios or Polyhydramnios (AFI > 95th percentile or < 5th percentile).
- Obese patient, BMI > 30
- Intrauterine growth restriction.
- Fetal spine between the 11- and 1- O'clock positions due to possibility of shadowing from ribs or spine
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
Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound
Time frame: 20 - 36 weeks of gestation
Fetal Echocardiography by Two-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views: 1. Four chamber view 2. Five chamber view 3. Left outflow tract 4. Right outflow tract 5. 3 vessels and Trachea View 6. Abdomen/Stomach 7. Ductal arch 8. aortic arch 9. Bicaval view then we count howmuch views of nine views were satisfactory
1 secondary outcome
Number of Satisfactory Fetal Echocardiography Views by Five-Dimensional Ultrasound
Time frame: 20 - 36 weeks of gestation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Heart Echocardiography by Five Dimensional Ultrasound, run by Ain Shams University.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 Jul 2017. 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?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound (time frame: 20 - 36 weeks of gestation). 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 14 Jul 2017.