Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound

NCT ID: NCT02494440

Last Updated: 2016-08-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-03-31

Brief Summary

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

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.

Conditions

Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Mohamed Abdelrahman

Rehab Mohamed Abdelrahman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

5D LB

Identifier Type: -

Identifier Source: org_study_id