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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05837195
Other study ID # DDA2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 19, 2023
Est. completion date June 30, 2024

Study information

Verified date April 2023
Source Orthogyn Medical Center, Bulgaria
Contact Petar N Ignatov, PhD
Phone +359888963189
Email ignatov@orthogyn.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

DDA is a new Doppler parameter aiming to assess fetal well-being in-utero. Late-onset FGR is a specific subgroup of fetuses where the clinical application of this Doppler modality could play an essential role in detecting hypoxia, anemia, and other adverse neonatal outcomes.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 30, 2024
Est. primary completion date March 30, 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 after 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 after 32nd week of gestation

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Bulgaria Orthogyn Medical and Dental Center Sofia

Sponsors (1)

Lead Sponsor Collaborator
Orthogyn Medical Center, Bulgaria

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hypoxia in the newborn Defined by pH values < 7.20 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 1 minute after delivery
Secondary Apgar score at 5th minute Apgar score measured at 5th minute after delivery 5 minutes after delivery
Secondary Apgar score at 10th minute Apgar score measured at 10th minute after delivery 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
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