Fetal Heart Echocardiography by Five Dimensional Ultrasound
Conditions
Brief summary
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: 1. 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). 2. 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.
Interventions
None listed
Sponsors
Ain Shams University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
Yes
Inclusion criteria
1. Singleton pregnancy. 2. Gestational age at 34-36 weeks as determined be date and last menstrual period. 3. Normal Amniotic Fluid Index.
Exclusion criteria
1. Multiple pregnancies. 2. Oligohydramnios or Polyhydramnios (AFI \> 95th percentile or \< 5th percentile). 3. Obese patient, BMI \> 30 4. Intrauterine growth restriction. 5. Fetal spine between the 11- and 1- O'clock positions due to possibility of shadowing from ribs or spine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Satisfactory Fetal Echocardiography Views by Five-Dimensional Ultrasound | 20 - 36 weeks of gestation | Fetal Echocardiography by Five-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 |
Participant flow
Recruitment details
This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital. 90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Pregnant Women From 20 to 36 Weeks of Pregnancy This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.
90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.
Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart. | 90 |
| Total | 90 |
Baseline characteristics
| Characteristic | Pregnant Women From 20 to 36 Weeks of Pregnancy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants |
| Age, Continuous | 25 years STANDARD_DEVIATION 5 |
| Region of Enrollment Egypt | 90 participants |
| Sex: Female, Male Female | 90 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 |
Outcome results
Primary
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: 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
Time frame: 20 - 36 weeks of gestation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregnant Women From 20 to 36 Weeks of Pregnancy | Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound | 8.7 Number of satisfactory views | Standard Deviation 0.8 |
Secondary
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: 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
Time frame: 20 - 36 weeks of gestation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregnant Women From 20 to 36 Weeks of Pregnancy | Number of Satisfactory Fetal Echocardiography Views by Five-Dimensional Ultrasound | 8.9 Number of satisfactory views | Standard Deviation 0.4 |