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Diastolic Deceleration Area in Early-onset FGR

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05820464
Enrollment
300
Registered
2023-04-19
Start date
2022-04-19
Completion date
2024-04-01
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Hypoxia

Brief summary

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.

Interventions

DIAGNOSTIC_TESTDDA Doppler

A new Doppler parameter to quantify the amount of vasodilatation in the middle cerebral artery (MCA) and other blood vessels.

Sponsors

Orthogyn Medical Center, Bulgaria
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 48 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Hypoxia in the newbornimmediately after deliveryDefined by pH values below 7.20 in the umbilical artery
Anemia in the newbornimmediately after deliveryHemoglobin deviation from GA mean - mild \< 20 g/L, moderate - 20-70 g/L, severe \> 70 g/L
Occurence of hypoxic-ischemic encephalopathyfirst 72 hours after deliveryOccurence of hypoxic-ischemic encephalopathy in relation to some of the outcome measures

Secondary

MeasureTime frameDescription
Apgar score at 1st minute1 minute after deliveryApgar score measured at 1st minute after delivery. Scores ranging from 1 to 10, with higher scores meaning a better outcome.
Admissions to a NICUfirst 72 hours after deliveryAdmissions to a NICU indicated by or related to some of the outcome measures
Apgar score at 5th minute5 minutes after deliveryApgar score measured at 5th minute after delivery. Scores ranging from 1 to 10, with higher scores meaning a better outcome.
Apgar score at 10th minute10 minutes after deliveryApgar score measured at 10th minute after delivery. Scores ranging from 1 to 10, with higher scores meaning a better outcome.

Countries

Bulgaria

Contacts

Primary ContactPetar N Ignatov, PhD
ignatov@orthogyn.com+359888963189
Backup ContactTeodora B Yordanova-Ignatova, PhD
yordanova@orthogyn.com+359888226360

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026