Evaluation of Fetal Cardiac Function and Vascular Hemodynamics in Intrauterine Growth Restriction

Fetal Hypoxia Clinical Trial

Official title:

Evaluation of Non Invasive Fetal Cardiac Functions and Fetal Arterial&Venous Doppler Study in Intrauterine Growth Restriction as Predictive Parameters of Perinatal Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108040
• Other study ID #: AUN80
• Status: Completed
• Start date: May 10, 2017
• Est. completion date: January 10, 2020

Study information

• Verified date: February 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Intrauterine growth restriction (IUGR) is one of the major contributors to perinatal mortality and morbidity and is characterized by complex hemodynamic changes involving placental and fetal arterial, cardiac and venous circulations .However, the temporal sequence of these modifications in relation to other hemodynamic changes of the fetal arterial and venous circulations is unknown.

The aim of this study was to evaluate cardiac function and other hemodynamic changes in a group of fetuses with IUGR and clinical impact on perinatal outcome .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: January 10, 2020
• Est. primary completion date: July 10, 2019
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Singleton fetus with normal fetal anatomy documented a detailed sonogram.

• Fetal abdominal circumference <5th percentile for gestational age.

• Evidence of placental insufficiency documented by an elevated umbilical artery pulsatility index (UA-PI) by reference ranges.

Exclusion Criteria:

• evidence of fetal infection

• chorioamnionitis

• fetal anomalies

• abnormal fetal karyotype

• patient withdrawal from the study and/or unavailability for follow-up.

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Fetal Hypoxia
• Hypoxia

Locations

Country	Name	City	State
Egypt	Advanced Fetal Cair Unit - Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial performance index	Ratio between isovolumetric time to ejection time	5 minutes
Primary	Aortic isthmus flow index	Aortic isthmus flow index = Ratio of (systolic velocity time integral+diastolic velocity time integral) / systolic velocity time integral	5 minutes
Primary	Cerebroplacental ratio	cerebroplacental ratio = Rtio middle cerebral artery pulsatility index / umbilical artery pulsatility index	5 minutes
Primary	Preload Index in inferior vena cava	Preload Index in inferior vena cava = ratio of peak systolic velocity in atrial contraction /peak systolic velocity ventricular systole	5 minutes