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Completed

NCT Number: NCT06381258

Fetal Cardiac Function

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ultrasound

Procedure

Fetal echocardiography using ultrasound device

Primary outcomes

  1. Cardiac systolic function

    Time frame: 4 months

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

Secondary outcomes

  1. Cardiac diastolic function

    Time frame: 4 months

    Measurement of spherity index ( high is bad, low is good)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Fetal Systolic and Diastolic Cardiac Function Assessment in Mothers with Preeclampsia

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.