Fetal Cardiac Function

NCT06381258 | Completed DMC

• 1 other identifier: SDF
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to evaluate the effect of PE and FGR on fetal cardiac function. Pregnancies with preeclampsia and FGR, and preeclampsia with normal fetal growth are evaluated by echocardiography and compared with uncomplicated pregnancies.

Conditions

Fetal Growth Retardation

Outcome Measures

Primary Outcomes (1)

• Cardiac systolic function

  Measurement of ejection fraction in percent % (high is good, low is bad)

  4 months

Secondary Outcomes (1)

• Cardiac diastolic function

  4 months

Study Arms (2)

Patients with preeclampsia

Fetal ultrasound( echocardiography).Measurements will be performed using conventional pulsed-wave Doppler and M mode cross sectional image of the fetal thorax at the level of the 4-chamber view with an apical projection of the heart is obtained. Measurements of the ventricle at diastole and systole are obtained, and using the relationship between these measurements, calculations are performed to determine the ejection fraction (EF) (\[diastole measurement-systole measurement\]/diastole) measurement and shortening fraction ( SF) for both right \& left ventricles. Assessment of ventricular diastolic function through measuring E-wave (early ventricular filling) and A wave (active atrial contraction - late ventricular filling) peak velocities and the ratio between them (E/A ratio) as an index will be performed for both mitral valve (MV) and tricuspid valve (TV)

Procedure: Ultrasound

Patients without preeclampsia

Fetal ultrasound (echocardiography).Measurements will be performed using conventional pulsed-wave Doppler and M mode cross sectional image of the fetal thorax at the level of the 4-chamber view with an apical projection of the heart is obtained. Measurements of the ventricle at diastole and systole are obtained, and using the relationship between these measurements, calculations are performed to determine the ejection fraction (EF) (\[diastole measurement-systole measurement\]/diastole) measurement and shortening fraction ( SF) for both right \& left ventricles. Assessment of ventricular diastolic function through measuring E-wave (early ventricular filling) and A wave (active atrial contraction - late ventricular filling) peak velocities and the ratio between them (E/A ratio) as an index will be performed for both MV and TV

Procedure: Ultrasound

Interventions

Ultrasound PROCEDURE

Fetal echocardiography using ultrasound device

Patients with preeclampsia; Patients without preeclampsia

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group A : patients with preeclampsia (either with FGR or normal growth) Group B : patients without preeclampsia (16 cases)

You may qualify if:

• Pregnant women more than or equals 28 weeks
• Preeclampsia defined as systolic blood pressure 140 mm Hg and/or diastolic blood pressure 90 mm Hg
• Fetus with normal growth or with growth restriction

You may not qualify if:

• congenital malformations
• intrauterine infection
• multiple pregnancies
• fetuses of mothers treated with a tocolytic agent
• fetuses with abnormal heart rates (tachycardia or bradycardia)

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women's Health Hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obs& Gyn. Specialist of Urogynecology

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: April 30, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 12, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)