Anemia Clinical Trial
Official title:
Diastolic Deceleration Area in Severe Early-onset Growth Restriction of the Fetus
NCT number | NCT05820464 |
Other study ID # | DDA1 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 19, 2022 |
Est. completion date | April 1, 2024 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | April 1, 2024 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 48 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Orthogyn Medical and Dental Center | Sofia |
Lead Sponsor | Collaborator |
---|---|
Orthogyn Medical Center, Bulgaria |
Bulgaria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hypoxia in the newborn | Defined by pH values below 7.20 in the umbilical artery | immediately after delivery | |
Primary | 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 | |
Primary | Occurence of hypoxic-ischemic encephalopathy | Occurence of hypoxic-ischemic encephalopathy in relation to some of the outcome measures | first 72 hours after delivery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Admissions to a NICU | Admissions to a NICU indicated by or related to some of the outcome measures | first 72 hours after delivery |
Status | Clinical Trial | Phase | |
---|---|---|---|
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