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Fetal Cardiac Function

NCT ID: NCT06381258

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-30

Study Completion Date

2024-12-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fetal Growth Retardation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Ultrasound

Intervention Type PROCEDURE

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

Ultrasound

Intervention Type PROCEDURE

Fetal echocardiography using ultrasound device

Interventions

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Ultrasound

Fetal echocardiography using ultrasound device

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Gamal M.fekry

Lecturer of Obs& Gyn. Specialist of Urogynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Women's Health Hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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SDF

Identifier Type: -

Identifier Source: org_study_id