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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03108040

Enrollment

534

Registered

2017-04-11

Start date

2017-05-10

Completion date

2020-01-10

Last updated

2020-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Hypoxia

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 .

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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
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

Countries

Egypt

Outcome results