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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Standard care:
| ||
| DDA Doppler group | Standard care plus DDA Doppler monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DDA Doppler | Diagnostic Test | A new Doppler parameter to quantify the amount of vasodilatation in the middle cerebral artery (MCA) and other blood vessels. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant subjects only
No specific criteria, apart from the listed inclusion/exclusion ones
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Petar N Ignatov, PhD | Contact | +359888963189 | ignatov@orthogyn.com | |
| Teodora B Yordanova-Ignatova, PhD | Contact | +359888226360 | yordanova@orthogyn.com |
| Name | Affiliation | Role |
|---|---|---|
| Petar N Ignatov, PhD | Orthogyn Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthogyn Medical and Dental Center | Recruiting | Sofia | 1606 | Bulgaria |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
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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 |
| D006425 | Hemic and Lymphatic Diseases |