Diastolic Deceleration Area in Early-onset FGR

Study Overview
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Brief Summary
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DDA is a new Doppler parameter aiming to assess fetal well-being in-utero. Early-onset SGR is a specific subgroup of fetuses where the clinical application of this Doppler modality could play an important role in the detection of hypoxia, anemia, and brain-sparing.

Official Title
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Diastolic Deceleration Area in Severe Early-onset Growth Restriction of the Fetus

Conditions
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Hypoxia, Anemia

Intervention / Treatment
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* Diagnostic Test: DDA Doppler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: absence of fetal abnormalities and/or genetic conditions; single pregnancy; fetal growth restriction (FGR) < 10%, according to the INTERGROWTH 21st nomograms, appearing before 32nd week of gestation Exclusion Criteria: documented fetal abnormalities and/or genetic conditions in the course of the pregnancy; multiple pregnancy; absence of fetal growth restriction (FGR) < 10%, according to the INTERGROWTH 21st nomograms before 32nd week of gestation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Standard care: Doppler velocimetry: UA & MCA PI, DV PIV, CPR; Indirect cardiotocography (CTG) Biophysical profile (BPP) | |
| DDA Doppler group<br>Standard care plus DDA Doppler monitoring | Diagnostic Test: DDA Doppler<br>* A new Doppler parameter to quantify the amount of vasodilatation in the middle cerebral artery (MCA) and other blood vessels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxia in the newborn | Defined by pH values below 7.20 in the umbilical artery | immediately after delivery | 
| Anemia in the newborn | Hemoglobin deviation from GA mean - mild < 20 g/L, moderate - 20-70 g/L, severe > 70 g/L | immediately after delivery | 
| Occurence of hypoxic-ischemic encephalopathy | Occurence of hypoxic-ischemic encephalopathy in relation to some of the outcome measures | first 72 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apgar score at 1st minute | Apgar score measured at 1st minute after delivery. Scores ranging from 1 to 10, with higher scores meaning a better outcome. | 1 minute after delivery | 
| Apgar score at 5th minute | Apgar score measured at 5th minute after delivery. Scores ranging from 1 to 10, with higher scores meaning a better outcome. | 5 minutes after delivery | 
| Apgar score at 10th minute | Apgar score measured at 10th minute after delivery. Scores ranging from 1 to 10, with higher scores meaning a better outcome. | 10 minutes after delivery | 
| Admissions to a NICU | Admissions to a NICU indicated by or related to some of the outcome measures | first 72 hours after delivery |