Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound

The purpose of the study to evaluate Five-Dimensional Ultrasound in automated measurement of the fetal femur length at third trimester of pregnancy.

Study Overview

• Status: Completed
• Conditions: Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound

Detailed Description

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:

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 femur length .

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.

• Study Type: Observational
• Enrollment (Actual): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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 the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

Description

Inclusion Criteria:

1. Singleton pregnancy.
2. At third trimester of pregnancy.
3. The patient must be sure of her last normal menstrual period, last three regular cycles and no hormonal contraception before pregnancy.

Exclusion Criteria:

1. Multiple pregnancies.
2. Fetal anomalies.
3. Amniotic fluid index < 5 cm.
4. Medical disorder as diabetes mellitus, hypertension.
5. Obese patients. BMI > 30
6. Intrauterine growth retardation.
7. Post term pregnancy > 41 weeks.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: July 8, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Estimate): August 18, 2016
• Last Update Submitted That Met QC Criteria: July 11, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 5D LB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound