Diastolic Deceleration Area in Late-onset FGR

Orthogyn Medical Center, Bulgaria

Status: Enrolling

Conditions: Anemia; Hypoxia

Treatments: Device: DDA Doppler

Study type: Observational

Funder types: Other

Identifiers

NCT05837195

DDA2

Details and patient eligibility

About

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.

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 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

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:

Device: DDA Doppler