Fetal Cardiac Function

Fetal Growth Retardation Clinical Trial

Official title:

Fetal Systolic and Diastolic Cardiac Function Assessment in Mothers With Preeclampsia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06381258
• Other study ID #: SDF
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Fetal Growth Retardation

Intervention

Procedure:
• Ultrasound
Fetal echocardiography using ultrasound device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac systolic function	Measurement of ejection fraction in percent % (high is good, low is bad)	4 months
Secondary	Cardiac diastolic function	Measurement of spherity index ( high is bad, low is good)	4 months