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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03108040
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Sief el eslam Ahmed Ali, 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 .


Condition or disease
Fetal Hypoxia

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Study Type : Observational
Actual Enrollment : 534 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Actual Study Start Date : May 10, 2017
Actual Primary Completion Date : July 10, 2019
Actual Study Completion Date : January 10, 2020



Primary Outcome Measures :
  1. Myocardial performance index [ Time Frame: 5 minutes ]
    Ratio between isovolumetric time to ejection time

  2. 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

  3. Cerebroplacental ratio [ Time Frame: 5 minutes ]
    cerebroplacental ratio = Rtio middle cerebral artery pulsatility index / umbilical artery pulsatility index

  4. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108040


Locations
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Egypt
Advanced Fetal Cair Unit - Assiut University
Assiut, Egypt
Sponsors and Collaborators
Assiut University
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Responsible Party: Sief el eslam Ahmed Ali, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03108040    
Other Study ID Numbers: AUN80
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Hypoxia
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes