Diastolic Deceleration Area in Early-onset FGR

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05820464
• Other study ID #: DDA1
• Status: Recruiting
• Start date: April 19, 2022
• Est. completion date: April 1, 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 1, 2024
• Est. primary completion date: February 1, 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 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

Related Conditions & MeSH terms

• Anemia
• Hypoxia

Intervention

Diagnostic Test:
• 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 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