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The purpose of the study to evaluate Five-Dimensional Ultrasound in automated measurement of the fetal femur length at third trimester of pregnancy.
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 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:
The FL at Two-Dimensional Ultrasound (Gold standard) will be made from the center of the 'U' shape at each end of the bone.
The FL at Five-Dimensional Ultrasound will be measured by Pressing Five-Dimensional Ultrasound long bone Button to extract Fetal Long Bones automatically.
The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be compared to gestational age calculated by accurate dates of the last menstrual period.
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| Measure | Description | Time Frame |
|---|---|---|
| Gestational Age Calculated by Accurate Dates of the Last Menstrual Period | The patient must be sure of her last normal menstrual period, last three regular cycles and no hormonal contraception before pregnancy. Gestational age calculated by the last menstrual period | 26 - 40 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational Age Calculated by Femur Length Measurement by Two-Dimensional Ultrasound | The femur length at Two-Dimensional Ultrasound (Gold standard) was made from the center of the 'U' shape at each end of the bone. After the long axis of the fetus was identified, the transducer was turned 90 degrees to produce a cross sectional image of fetal trunk, maintaining the 90 degrees angle until the lower spine and iliac crest were identified, then the transducer was rotated until a full femur was imaged. The femur length was measured from the center of the "U" shape at each end of the bone; this represented the length of the metaphysis). then , Gestational Age Calculated by femur length measurement |
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Inclusion Criteria:
Exclusion Criteria:
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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 the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.
Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound
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study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital from march 2015 to march 2016.
Ninety pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria. They were counseled and after consenting were included into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregnant Women at Third Trimester of Pregnancy |
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Ninety pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnant Women at Third Trimester of Pregnancy |
|
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gestational Age Calculated by Accurate Dates of the Last Menstrual Period | The patient must be sure of her last normal menstrual period, last three regular cycles and no hormonal contraception before pregnancy. Gestational age calculated by the last menstrual period | 90 pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria | Posted | Mean | Standard Deviation | weeks | 26 - 40 weeks of gestation |
|
1 year from march 2015 to march 2016
Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were performed and adverse Events Adverse Events were assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregnant Women at Third Trimester of Pregnancy |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Rehab Mohamed Abdelrahman | Ain Shams University | +201004992772 | rehababdulrahman.rm@gmail.com |
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| 26 - 40 weeks of gestation |
| Gestational Age Calculated by Femur Length Measurement by Five-Dimensional Ultrasound | The femur length at Five-Dimensional Ultrasound: To obtain 3D volume data, the entire bone length of the femur was identified on the screen, as in the 2D-ultrasound measurement, and the long axis of the femur was placed in the direction of the x axis in the image in which the ultrasound beam was perpendicular to the bone. The 5D LB set key was pressed on the system, wherein the system automatically analyzed the 3D volume data, reconstructed the 3D image of the long bones, and displayed the measured length of the femur length on the screen was measured by pressing 5D LB Button to extract Fetal Long Bones automatically. then, gestational Age Calculated by femur length measurement | 26 - 40 weeks of gestation |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Gestational Age Calculated by Femur Length Measurement by Two-Dimensional Ultrasound | The femur length at Two-Dimensional Ultrasound (Gold standard) was made from the center of the 'U' shape at each end of the bone. After the long axis of the fetus was identified, the transducer was turned 90 degrees to produce a cross sectional image of fetal trunk, maintaining the 90 degrees angle until the lower spine and iliac crest were identified, then the transducer was rotated until a full femur was imaged. The femur length was measured from the center of the "U" shape at each end of the bone; this represented the length of the metaphysis). then , Gestational Age Calculated by femur length measurement | 90 pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria | Posted | Mean | Standard Deviation | weeks | 26 - 40 weeks of gestation |
|
|
|
| Secondary | Gestational Age Calculated by Femur Length Measurement by Five-Dimensional Ultrasound | The femur length at Five-Dimensional Ultrasound: To obtain 3D volume data, the entire bone length of the femur was identified on the screen, as in the 2D-ultrasound measurement, and the long axis of the femur was placed in the direction of the x axis in the image in which the ultrasound beam was perpendicular to the bone. The 5D LB set key was pressed on the system, wherein the system automatically analyzed the 3D volume data, reconstructed the 3D image of the long bones, and displayed the measured length of the femur length on the screen was measured by pressing 5D LB Button to extract Fetal Long Bones automatically. then, gestational Age Calculated by femur length measurement | Ninety pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria | Posted | Mean | Standard Deviation | weeks | 26 - 40 weeks of gestation |
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| 0 |
| 90 |
| 0 |
| 90 |
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