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

A

Ain Shams University

Status

Completed

Conditions

Fetal Heart Echocardiography by Five Dimensional Ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT02643199
5D Echocardiography

Details and patient eligibility

About

The aim of the study to evaluate Five-Dimensional Ultrasound in automated assessment of the fetal heart from 20-36 weeks of gestation.

Full description

This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.

90 pregnant women will be recruited from 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 Heart.

    • 90 consecutive patients will undergo 2D fetal echocardiography by one observer
    • Then they will undergo blindly Five-Dimensional fetal echocardiography by another observer
    • The data collected will be compared to evaluate the accuracy of Five-Dimensional US in fetal heart assessment.

Enrollment

90 patients

Sex

Female

Ages

18 to 38 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Singleton pregnancy.
  2. Gestational age at 34-36 weeks as determined be date and last menstrual period.
  3. Normal Amniotic Fluid Index.

Exclusion criteria

  1. Multiple pregnancies.
  2. Oligohydramnios or Polyhydramnios (AFI > 95th percentile or < 5th percentile).
  3. Obese patient, BMI > 30
  4. Intrauterine growth restriction.
  5. Fetal spine between the 11- and 1- O'clock positions due to possibility of shadowing from ribs or spine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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