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

Completed

• Conditions: Fetal Hypoxia

• Registration Number: NCT03108040
• Lead Sponsor: Assiut University

Brief 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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Study Start: 2017-05-10
• Primary Completion: 2019-07-10
• Study Completion: 2020-01-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-15
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 534

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Advanced Fetal Cair Unit - Assiut University; 🇪🇬 Assiut, Egypt