Diastolic Deceleration Area in Early-onset FGR

NCT05820464 | Unknown

• 1 other identifier: DDA1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia; Anemia

Outcome Measures

Primary Outcomes (3)

• Hypoxia in the newborn

  Defined by pH values below 7.20 in the umbilical artery

  immediately after delivery

• 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

• Occurence of hypoxic-ischemic encephalopathy

  Occurence of hypoxic-ischemic encephalopathy in relation to some of the outcome measures

  first 72 hours after delivery

Secondary Outcomes (4)

• Apgar score at 1st minute

  1 minute after delivery

• Apgar score at 5th minute

  5 minutes after delivery

• Apgar score at 10th minute

  10 minutes after delivery

• Admissions to a NICU

  first 72 hours after delivery

Study Arms (2)

Control group

Standard care: * Doppler velocimetry: UA \& MCA PI, DV PIV, CPR; * Indirect cardiotocography (CTG) * Biophysical profile (BPP)

DDA Doppler group

Standard care plus DDA Doppler monitoring

Diagnostic Test: DDA Doppler

Interventions

DDA Doppler DIAGNOSTIC_TEST

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

DDA Doppler group

Eligibility Criteria

• Age: 18 Years - 48 Years
• Gender Eligibility Details: Pregnant subjects only
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

No specific criteria, apart from the listed inclusion/exclusion ones

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthogyn Medical Center, Bulgaria: lead

Study Sites (1)

Orthogyn Medical and Dental Center

Sofia, 1606, Bulgaria

RECRUITING

MeSH Terms

Conditions

Hypoxia; Anemia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Petar N Ignatov, PhD

  Orthogyn Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petar N Ignatov, PhD

CONTACT

+359888963189; ignatov@orthogyn.com

Teodora B Yordanova-Ignatova, PhD

CONTACT

+359888226360; yordanova@orthogyn.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof. Petar Ignatov, M.D., Ph. D.

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: April 19, 2022
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-04

Locations

BU (1)