PregnancyNCT02675595
5D Versus Conventional 2D Fetal Echocardiography During Second Trimester of Pregnancy
An observational study of Pregnancy, run by Ain Shams University at 1 site in Egypt.
Trial summary
Hypothesis: In Women in the second trimester of pregnancy 5D offers an alternative method for fetal Echocardiography compared to conventional 2D scanning Question: Does 5D software technology is as efficient as 2D scanning in fetal echocardiography of second trimesteric fetuses? Aim: This study aims at assessing the… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to May 2018
- How long will I take part?
- 1 Day
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Second trimester pregnant women
Who may be able to join
- Living fetus.
- Singleton
- No gross fetal structural malformation
- No maternal Medical Disorders
- G.A : in between 20-26 wks.
- Verbal consent informing the aim and process of this study
Who cannot join
- the fetal spine between the 9- and 3-o'clock positions
- Missed Abortion.
- women with body mass index (BMI) ≥30 kg/m2
- GA : before 20 wk.
- presence of polyhydramnios or oligohydramnios (amniotic fluid index >95th percentile or < 5th percentile)
- Detectable or suspected fetal cardiac anomaly
- Fetal congenital malformation
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospital
Cairo, Cairo Governorate, 11371
Omneya Elmakhzangy, Masters, 0020109479504, nano_mak@yahoo.co.uk
Omneya EL makhzangy, masters
About this study
Official title: Prospective Evaluation of Fetal Intelligent Navigation Echocardiography (FINE)(5D) Versus Conventional 2D Echocardiography in Comprehensive Fetal Cardiac Imaging in the Second Trimester of Pregnancy
Hypothesis:
In Women in the second trimester of pregnancy 5D offers an alternative method for fetal Echocardiography compared to conventional 2D scanning
Question:
Does 5D software technology is as efficient as 2D scanning in fetal echocardiography of second trimesteric fetuses?
Aim:
This study aims at assessing the accuracy of performance of the 5D as a new scanning technology in fetal Echocardiography compared to the conventional use of 2D scanning.
Read the detailed description
Congenital malformations account for more than 20% of all infant deaths(CDC,2014), and congenital heart defects are the most common types of birth defects.
The prenatal diagnosis of major congenital heart defects remains a challenge. Publications by Acherman et al (Acherman RJ .et al) and Sklansky et al (Sklansky MS.et al)have found that approximately 35% of cardiac anomalies are detected prenatally, a frequency that is not substantially different from that documented by Wigton et al in 1993 (Wigton TR, et al) Advances in prenatal ultrasonography have improved prenatal care in recent decades and increased the detection of a large number of congenital malformations. The prenatal detection rate of congenital heart disease (CHD), however, has not shown the same increase as the detection of malformations in other fetal systems (DeVore GR, et al). CHDs are the most commonly overlooked lesions in prenatal screening programs(Garne E et al, Tegnander E et al). This causes concern as CHD represents the most common congenital malformation and is the leading cause of infant mortality in the first year of postnatal life(Garne E). It has been estimated that the prevalence of CHD is 4-8 per 1000 neonates(Hoffman JI et al).
Early detection and accurate prenatal diagnosis of CHD reduces neonatal morbidity and mortality rates by allowing provision of adequate prenatal and postnatal care(Randall P et al, Goncalves LF et al). Before viability is reached, parents can be counseled on the diagnosis, severity and prognosis. Furthermore, it provides parents with the opportunityto make informed decisions on the further course of pregnancy. The four-chamber view has become the standard approach in screening for CHD. Identification of the right and left outflow tracts markedly improves the detection rate of CHD(DeVore GR et al, Stumpflen I et al).
Prenatal detection of these anomalies has proved challenging. In a British study from 1999, Bull(AIUM 2013) reported on 4799 pregnancies affected by major congenital heart defects and found that the antenatal detection rate was only 24%. Lower detection rates were noted in centers that only assessed the 4-chamber view. Correspondingly, in an attempt to improve the antenatal detection rates of congenital heart defects, the American Institute of Ultrasound in Medicine, American College of Obstetricians and Gynecologists, and International Society of Ultrasound in Obstetrics and Gynecology all have recommended that an attempt should be made to image the ventricular outflow tracts during the fetal anatomic survey.( Carvalho JS et al. , Bull C., AIUM 2003)
However, imaging of these outflow tracts can be challenging, and it is not clear that they can be typically obtained in generalized non-tertiary care settings. A 2007 study from the United States, which included 77,000 births, found that only 36% of major congenital heart defects were detected antenatally. It is not clear from the study whether outflow views were routinely obtained at all of the laboratories involved, but the study suggests that better detection rates could be achieved if outflow views were more routinely imaged.( Bull C. )
In an effort to improve antenatal detection of these anomalies, the American Institute of Ultrasound in Medicine, the American College of Obstetricians and Gynecologists, and the International Society of Ultrasound in Obstetrics and Gynecology have suggested that routine ultrasound examinations should attempt to include views of the cardiac outflow tracts. (AIUM 2003)
The myriad of fetal positions and the different maternal factors that influence the examination make fetal echocardiography one of the more difficult tasks for sonographers. To help improve and standardize fetal cardiac examinations, Yagel et al. and Yoo et al. described a method in which five cardiac planes are visualizedfor a complete examination of the fetal heart(Yoo SJ et al,Yagel et al ). Additionally, three- and four-dimensional (3D and 4D) ultrasound imaging can be a valuable tool in fetal echocardiography(ACOG 2004, Chaoui R et al,AIUM 2010, Yagel S et al M. C. Haak et al , Luciane Alves Rocha et al Rocha LA et al )
Other proposals have included obtaining routine 2-dimensional (2D) cine clips, universal fetal echocardiography, and routine use of 3-dimensional (3D) fast acquisition volumes. One reason that 3D sonographic technologies have been suggested is because routine visualization of cardiac views has proven to be a challenge with 2D imaging in centers that are less experienced with prenatal diagnosis, and 3D stored volumes could then be evaluated further by those more experienced.( M. C. Haak et al , Luciane Alves Rocha, et al, Rocha LA et al )
Fetal Intelligent Navigation Echocardiography (FINE) 5D work flow refers to semi-automated identification of specific diagnostic image planes and measurements from a volume dataset simultaneously displaying nine standard fetal cardiac views. It allows the examination of cardiac planes, such as the axial planes and view of the interventricular septum (IVS plane) which are technically very difficult to image using conventional two-dimensional (2D) echocardiography (Rocha LA et al).
However, to be an effective tool in fetal echocardiography, 5D volume acquisition must be feasible in routine clinical practice. A number of reports on these new technologies have emphasized the requirement of a substantial learning curve for the use of 5D ultrasound imaging(M. C. Haak et al , Luciane Alves Rocha et al ). This may explain the delay in widespread introduction of this new technique in first- and second level ultrasound departments, and even in tertiary referral centers.
- Conditions
- Pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtaining standard 9 views of fetal echocardiography by 5D as well as 2D
All 80 fetuses will undergo 2D and 5D detailed fetal echocardiography to obtain the standard nine cardiac views according to standards set by AIUM (American Institute of Ultrasound in Medicine) and both modalities will be compared by their ability to obtain the nine standard cardiac views.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omneya Nagy ELmakhzangy, Ain Shams University
- Investigators
- Omneya Nagy ELmakhzangy, masters, Principal investigator, Specialist at Ain Shams UniversityOmneya Nagy ELmakhzangy, masters, Principal investigator, Specialist Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675595
- Sponsor's protocol ID
- MD thesis
- Status last verified
- Jan 2016
- First submitted
- 21 Jan 2016
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Fetal Intelligent Navigation Echocardiography (FINE)(5D) Versus Conventional 2D Echocardiography in Comprehensive Fetal Cardiac Imaging in the Second Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT02675595
- Acronym / sponsor ID
- MD thesis
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 5 Feb 2016 (estimated)
- 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.
Hypothesis:
In Women in the second trimester of pregnancy 5D offers an alternative method for fetal Echocardiography compared to conventional 2D scanning
Question:
Does 5D software technology is as efficient as 2D scanning in fetal echocardiography of second trimesteric fetuses?
Aim:
This study aims at assessing the accuracy of performance of the 5D as a new scanning technology in fetal Echocardiography compared to the conventional use of 2D scanning.
Detailed description
Congenital malformations account for more than 20% of all infant deaths(CDC,2014), and congenital heart defects are the most common types of birth defects.
The prenatal diagnosis of major congenital heart defects remains a challenge. Publications by Acherman et al (Acherman RJ .et al) and Sklansky et al (Sklansky MS.et al)have found that approximately 35% of cardiac anomalies are detected prenatally, a frequency that is not substantially different from that documented by Wigton et al in 1993 (Wigton TR, et al) Advances in prenatal ultrasonography have improved prenatal care in recent decades and increased the detection of a large number of congenital malformations. The prenatal detection rate of congenital heart disease (CHD), however, has not shown the same increase as the detection of malformations in other fetal systems (DeVore GR, et al). CHDs are the most commonly overlooked lesions in prenatal screening programs(Garne E et al, Tegnander E et al). This causes concern as CHD represents the most common congenital malformation and is the leading cause of infant mortality in the first year of postnatal life(Garne E). It has been estimated that the prevalence of CHD is 4-8 per 1000 neonates(Hoffman JI et al).
Early detection and accurate prenatal diagnosis of CHD reduces neonatal morbidity and mortality rates by allowing provision of adequate prenatal and postnatal care(Randall P et al, Goncalves LF et al). Before viability is reached, parents can be counseled on the diagnosis, severity and prognosis. Furthermore, it provides parents with the opportunityto make informed decisions on the further course of pregnancy. The four-chamber view has become the standard approach in screening for CHD. Identification of the right and left outflow tracts markedly improves the detection rate of CHD(DeVore GR et al, Stumpflen I et al).
Prenatal detection of these anomalies has proved challenging. In a British study from 1999, Bull(AIUM 2013) reported on 4799 pregnancies affected by major congenital heart defects and found that the antenatal detection rate was only 24%. Lower detection rates were noted in centers that only assessed the 4-chamber view. Correspondingly, in an attempt to improve the antenatal detection rates of congenital heart defects, the American Institute of Ultrasound in Medicine, American College of Obstetricians and Gynecologists, and International Society of Ultrasound in Obstetrics and Gynecology all have recommended that an attempt should be made to image the ventricular outflow tracts during the fetal anatomic survey.( Carvalho JS et al. , Bull C., AIUM 2003)
However, imaging of these outflow tracts can be challenging, and it is not clear that they can be typically obtained in generalized non-tertiary care settings. A 2007 study from the United States, which included 77,000 births, found that only 36% of major congenital heart defects were detected antenatally. It is not clear from the study whether outflow views were routinely obtained at all of the laboratories involved, but the study suggests that better detection rates could be achieved if outflow views were more routinely imaged.( Bull C. )
In an effort to improve antenatal detection of these anomalies, the American Institute of Ultrasound in Medicine, the American College of Obstetricians and Gynecologists, and the International Society of Ultrasound in Obstetrics and Gynecology have suggested that routine ultrasound examinations should attempt to include views of the cardiac outflow tracts. (AIUM 2003)
The myriad of fetal positions and the different maternal factors that influence the examination make fetal echocardiography one of the more difficult tasks for sonographers. To help improve and standardize fetal cardiac examinations, Yagel et al. and Yoo et al. described a method in which five cardiac planes are visualizedfor a complete examination of the fetal heart(Yoo SJ et al,Yagel et al ). Additionally, three- and four-dimensional (3D and 4D) ultrasound imaging can be a valuable tool in fetal echocardiography(ACOG 2004, Chaoui R et al,AIUM 2010, Yagel S et al M. C. Haak et al , Luciane Alves Rocha et al Rocha LA et al )
Other proposals have included obtaining routine 2-dimensional (2D) cine clips, universal fetal echocardiography, and routine use of 3-dimensional (3D) fast acquisition volumes. One reason that 3D sonographic technologies have been suggested is because routine visualization of cardiac views has proven to be a challenge with 2D imaging in centers that are less experienced with prenatal diagnosis, and 3D stored volumes could then be evaluated further by those more experienced.( M. C. Haak et al , Luciane Alves Rocha, et al, Rocha LA et al )
Fetal Intelligent Navigation Echocardiography (FINE) 5D work flow refers to semi-automated identification of specific diagnostic image planes and measurements from a volume dataset simultaneously displaying nine standard fetal cardiac views. It allows the examination of cardiac planes, such as the axial planes and view of the interventricular septum (IVS plane) which are technically very difficult to image using conventional two-dimensional (2D) echocardiography (Rocha LA et al).
However, to be an effective tool in fetal echocardiography, 5D volume acquisition must be feasible in routine clinical practice. A number of reports on these new technologies have emphasized the requirement of a substantial learning curve for the use of 5D ultrasound imaging(M. C. Haak et al , Luciane Alves Rocha et al ). This may explain the delay in widespread introduction of this new technique in first- and second level ultrasound departments, and even in tertiary referral centers.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Second trimester pregnant women
Key inclusion criteria (6 listed)
- Living fetus.
- Singleton
- No gross fetal structural malformation
- No maternal Medical Disorders
- G.A : in between 20-26 wks.
Key exclusion criteria (7 listed)
- the fetal spine between the 9- and 3-o'clock positions
- Missed Abortion.
- women with body mass index (BMI) ≥30 kg/m2
- GA : before 20 wk.
- presence of polyhydramnios or oligohydramnios (amniotic fluid index >95th percentile or < 5th percentile)
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
Obtaining standard 9 views of fetal echocardiography by 5D as well as 2D
Time frame: 2 years
All 80 fetuses will undergo 2D and 5D detailed fetal echocardiography to obtain the standard nine cardiac views according to standards set by AIUM (American Institute of Ultrasound in Medicine) and both modalities will be compared by their ability to obtain the nine standard cardiac views.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Individual participant dataSharing planned: Undecided
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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.
Omneya Nagy ELmakhzangy, masters principal investigator
Specialist at Ain Shams University
Omneya Nagy ELmakhzangy, masters principal investigator
Specialist Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Ain Shams University at 1 site in Egypt.
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 6 inclusion and 7 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 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Omneya Nagy Elmakhzangy, Masters (0020224346370, nano_mak@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtaining standard 9 views of fetal echocardiography by 5D as well as 2D (time frame: 2 years). 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 5 Feb 2016.