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

NCT03108040 | Completed DMC

• 1 other identifier: AUN80
• Study Type: observational
• Target: 534
• Locations: 1 country
• Sites: 1

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 .

Conditions

Fetal Hypoxia

Outcome Measures

Primary Outcomes (4)

• Myocardial performance index

  Ratio between isovolumetric time to ejection time

  5 minutes

• Aortic isthmus flow index

  Aortic isthmus flow index = Ratio of (systolic velocity time integral+diastolic velocity time integral) / systolic velocity time integral

  5 minutes

• Cerebroplacental ratio

  cerebroplacental ratio = Rtio middle cerebral artery pulsatility index / umbilical artery pulsatility index

  5 minutes

• 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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

observational study conducted at academic perinatalcenter that investigates relationships between antenatal testing parameters and outcome in IUGR fetuses Patients who give written consent to participate in the study undergo a uniform antenatal assessment protocol that includes umbilical artery (UA), middle cerebral artery (MCA) and ductus venosus (DV) Doppler ultrasound studies as well as detailed fetal echocardiography and five-component biophysical profile score. \- Criteria for study eligibility are: * Singleton fetus with normal fetal anatomy documentedon a detailed sonogram. * Fetal abdominal circumference \<5th percentile forgestational age.• * Evidence of placental insufficiency documented by an elevated umbilical artery pulsatility index (UA-PI) by reference ranges.

You may qualify if:

• 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.

You may not qualify if:

• evidence of fetal infection
• chorioamnionitis
• fetal anomalies
• abnormal fetal karyotype
• patient withdrawal from the study and/or unavailability for follow-up.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Advanced Fetal Cair Unit - Assiut University

Asyut, Egypt

Location

MeSH Terms

Conditions

Fetal Hypoxia

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 11, 2017
• Study Start: May 10, 2017
• Primary Completion: July 10, 2019
• Study Completion: January 10, 2020
• Last Updated: February 18, 2020

Record last verified: 2020-02

Locations

EG (1)