Trial Outcomes & Findings for Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy (NCT NCT02643199)

Results Overview

Fetal Echocardiography by Two-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views: 1. Four chamber view 2. Five chamber view 3. Left outflow tract 4. Right outflow tract 5. 3 vessels and Trachea View 6. Abdomen/Stomach 7. Ductal arch 8. aortic arch 9. Bicaval view then we count howmuch views of nine views were satisfactory

Recruitment status

COMPLETED

Target enrollment

90 participants

Primary outcome timeframe

20 - 36 weeks of gestation

Results posted on

2017-07-14

Participant Flow

This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital. 90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.

Participant milestones

Participant milestones
Measure	Pregnant Women From 20 to 36 Weeks of Pregnancy This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital. 90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart.
Overall Study STARTED	90
Overall Study COMPLETED	90
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregnant Women From 20 to 36 Weeks of Pregnancy n=90 Participants This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital. 90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart.
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	25 years STANDARD_DEVIATION 5 • 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: 20 - 36 weeks of gestation

Fetal Echocardiography by Two-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views: 1. Four chamber view 2. Five chamber view 3. Left outflow tract 4. Right outflow tract 5. 3 vessels and Trachea View 6. Abdomen/Stomach 7. Ductal arch 8. aortic arch 9. Bicaval view then we count howmuch views of nine views were satisfactory

Outcome measures

Outcome measures
Measure	Pregnant Women From 20 to 36 Weeks of Pregnancy n=90 Participants This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital. 90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart.
Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound	8.7 Number of satisfactory views Standard Deviation 0.8

SECONDARY outcome

Timeframe: 20 - 36 weeks of gestation

Fetal Echocardiography by Five-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views: 1. Four chamber view 2. Five chamber view 3. Left outflow tract 4. Right outflow tract 5. 3 vessels and Trachea View 6. Abdomen/Stomach 7. Ductal arch 8. aortic arch 9. Bicaval view then we count howmuch views of nine views were satisfactory

Outcome measures

Outcome measures
Measure	Pregnant Women From 20 to 36 Weeks of Pregnancy n=90 Participants This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital. 90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart.
Number of Satisfactory Fetal Echocardiography Views by Five-Dimensional Ultrasound	8.9 Number of satisfactory views Standard Deviation 0.4

Adverse Events

Pregnant Women From 20 to 36 Weeks 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