Diastolic Deceleration Area in Late-onset FGR
Diastolic Deceleration Area (DDA) in Late-onset Fetal Growth Restriction (FGR)
1 other identifier
observational
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2023
CompletedStudy Start
First participant enrolled
April 19, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedMay 1, 2023
April 1, 2023
12 months
April 19, 2023
April 19, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Hypoxia in the newborn
Defined by pH values \< 7.20
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
Interventions
A new Doppler parameter to quantify the amount of vasodilatation in the middle cerebral artery (MCA) and other blood vessels.
Eligibility Criteria
Pregnant subjects only
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 after 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 after 32nd week of gestation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orthogyn Medical and Dental Center
Sofia, 1606, Bulgaria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petar N Ignatov, PhD
Orthogyn Medical Center
Central Study Contacts
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 19, 2023
First Posted
May 1, 2023
Study Start
April 19, 2023
Primary Completion
March 30, 2024
Study Completion
June 30, 2024
Last Updated
May 1, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share