Diastolic Deceleration Area in Late-onset FGR

Anemia Clinical Trial

Official title:

Diastolic Deceleration Area (DDA) in Late-onset Fetal Growth Restriction (FGR)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05837195
• Other study ID #: DDA2
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Anemia
• Hypoxia

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