Diastolic Deceleration Area in Late-onset FGR

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05837195

Enrollment

300

Registered

2023-05-01

Start date

2023-04-19

Completion date

2024-06-30

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Hypoxia

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.

Interventions

DEVICEDDA Doppler

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 48 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Hypoxia in the newborn	immediately after delivery	Defined by pH values \< 7.20
Anemia in the newborn	immediately after delivery	Hemoglobin deviation from GA mean - mild \< 20 g/L, moderate - 20-70 g/L, severe \> 70 g/L
Occurence of hypoxic-ischemic encephalopathy	first 72 hours after delivery	Occurence of hypoxic-ischemic encephalopathy in relation to some of the outcome measures

Secondary

Measure	Time frame	Description
Apgar score at 5th minute	5 minutes after delivery	Apgar score measured at 5th minute after delivery
Admissions to a NICU	first 72 hours after delivery	Admissions to a NICU indicated by or related to some of the outcome measures
Apgar score at 10th minute	10 minutes after delivery	Apgar score measured at 10th minute after delivery
Apgar score at 1st minute	1 minute after delivery	Apgar score measured at 1st minute after delivery

Countries

Bulgaria

Contacts

Primary ContactPetar N Ignatov, PhD

ignatov@orthogyn.com+359888963189

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026