Clinical trial NCT02494440: Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound
Official title: Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Gestational Age Calculated by Accurate Dates of the Last Menstrual Period
timeFrame: 26 - 40 weeks of gestation
Secondary outcomes:
measure: Gestational Age Calculated by Femur Length Measurement by Two-Dimensional Ultrasound
timeFrame: 26 - 40 weeks of gestation
measure: Gestational Age Calculated by Femur Length Measurement by Five-Dimensional Ultrasound
timeFrame: 26 - 40 weeks of gestation
Other outcomes:
Locations:
Study officials:
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