- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03108040
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
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
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Assiut, Egypt
- Advanced Fetal Cair Unit - Assiut University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
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Preload Index in inferior vena cava
Time Frame: 5 minutes
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Preload Index in inferior vena cava = ratio of peak systolic velocity in atrial contraction /peak systolic velocity ventricular systole
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5 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUN80
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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