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Diastolic Deceleration Area in Early-onset FGR

O

Orthogyn Medical Center, Bulgaria

Status

Enrolling

Conditions

Anemia
Hypoxia

Treatments

Diagnostic Test: DDA Doppler

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 48 years old

Volunteers

No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Control group
Description:
Standard care: * Doppler velocimetry: UA \& MCA PI, DV PIV, CPR; * Indirect cardiotocography (CTG) * Biophysical profile (BPP)
DDA Doppler group
Description:
Standard care plus DDA Doppler monitoring
Treatment:
Diagnostic Test: DDA Doppler

Trial contacts and locations

1

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Central trial contact

Teodora B Yordanova-Ignatova, PhD; Petar N Ignatov, PhD

Data sourced from clinicaltrials.gov

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