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

February 15, 2020 updated by: Sief el eslam Ahmed Ali, Assiut University

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

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 .

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

534

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Assiut, Egypt
        • Advanced Fetal Cair Unit - Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2017

Primary Completion (Actual)

July 10, 2019

Study Completion (Actual)

January 10, 2020

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

April 5, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 15, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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