Fetal Cardiac Function

Fetal Systolic and Diastolic Cardiac Function Assessment in Mothers with Preeclampsia

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.

Study Overview

• Status: Completed
• Conditions: Fetal Growth Retardation
• Intervention / Treatment: Procedure: Ultrasound

Detailed Description

Preeclampsia (PE) represent a major concern in public health, affecting 2-8% of all pregnancies and considered one of the leading causes of perinatal morbidity and mortality. Fetal growth restriction (FGR) ia also a common health problem affecting about 5-10% of all pregnancies and commonly associates with preeclampsia . It is estimated that 20% of cases of PE present with FGR and about 50% of early-onset FGR cases will eventually coexist with PE .

Both syndromes share some pathophysiologic features, with a variable involvement of placental insufficiency and cause fetal cardiovascular remodeling and adaptations . Fetal adaptations as metabolic and cardiovascular programming occur in response to adverse intrauterine conditions as PE and FGR . Offspring from preeclamptic pregnancies showed cardiac structural and functional changes and greater blood pressure in childhood and adolescence .

Most of the studies on FGR included pregnancies complicated by PE and vice versa, which fails to adequately assess the independent effect of each condition on the fetal cardiac functions.

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Women's Health Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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)

Description

Inclusion criteria:

• 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

Exclusion criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Fetal echocardiography using ultrasound device
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; Fetal echocardiography using ultrasound device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac systolic function	Measurement of ejection fraction in percent % (high is good, low is bad)	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac diastolic function	Measurement of spherity index ( high is bad, low is good)	4 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 12, 2024

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Fetal Diseases; Growth Disorders; Fetal Growth Retardation
• Other Study ID Numbers: SDF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No