This trial is active, not recruiting.

Condition automated fetal femur length measurement by 5d ultrasound
Sponsor Ain Shams University
Start date May 2015
End date February 2016
Trial size 90 participants
Trial identifier NCT02494440, 5D LB


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

measurement of fetal femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound
time frame: 10 months

Eligibility Criteria

Female participants from 20 years up to 35 years old.

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.

Additional Information

Official title Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound
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 (FL). 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 ( 5D LB ) 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Ain Shams University.