Trial Outcomes & Findings for Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound (NCT NCT02494440)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

90 participants

Primary outcome timeframe

26 - 40 weeks of gestation

Results posted on

2016-08-18

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Pregnant Women at Third Trimester of Pregnancy 1. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length. 2. The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period.
Overall Study STARTED	90
Overall Study COMPLETED	90
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregnant Women at Third Trimester of Pregnancy n=90 Participants 1. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length. 2. The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	90 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.1 years STANDARD_DEVIATION 4.7 • n=5 Participants
Sex: Female, Male Female	90 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Egypt	90 participants n=5 Participants

PRIMARY outcome

Timeframe: 26 - 40 weeks of gestation

Population: 90 pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria

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

Outcome measures

Outcome measures
Measure	Pregnant Women at Third Trimester of Pregnancy n=90 Participants 1. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length. 2. The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period.
Gestational Age Calculated by Accurate Dates of the Last Menstrual Period	35.6 weeks Standard Deviation 3.4

SECONDARY outcome

Timeframe: 26 - 40 weeks of gestation

Population: 90 pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria

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

Outcome measures

Outcome measures
Measure	Pregnant Women at Third Trimester of Pregnancy n=90 Participants 1. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length. 2. The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period.
Gestational Age Calculated by Femur Length Measurement by Two-Dimensional Ultrasound	33.4 weeks Standard Deviation 2.8

SECONDARY outcome

Timeframe: 26 - 40 weeks of gestation

Population: Ninety pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria

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

Outcome measures

Outcome measures
Measure	Pregnant Women at Third Trimester of Pregnancy n=90 Participants 1. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length. 2. The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period.
Gestational Age Calculated by Femur Length Measurement by Five-Dimensional Ultrasound	33.4 weeks Standard Deviation 2.9

Adverse Events

Pregnant Women at Third Trimester of Pregnancy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Rehab Mohamed Abdelrahman

Ain Shams University

Phone: +201004992772

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place