Diastolic Deceleration Area in Early-onset FGR

Recruiting

• Conditions: Anemia; Hypoxia
• Interventions: Diagnostic Test: DDA Doppler

• Registration Number: NCT05820464
• Lead Sponsor: Orthogyn Medical Center, Bulgaria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-19
• Status Verified: 2023-04
• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-06
• Study First Posted: 2023-04-19
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-05-03
• Primary Completion: 2024-02-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DDA Doppler group	DDA Doppler	Standard care plus DDA Doppler monitoring

Primary Outcome Measures

Name	Time	Method
Hypoxia in the newborn	immediately after delivery	Defined by pH values below 7.20 in the umbilical artery
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 Outcome Measures

Name	Time	Method
Apgar score at 10th minute	10 minutes after delivery	Apgar score measured at 10th minute after delivery. Scores ranging from 1 to 10, with higher scores meaning a better outcome.
Apgar score at 1st minute	1 minute after delivery	Apgar score measured at 1st minute after delivery. Scores ranging from 1 to 10, with higher scores meaning a better outcome.
Apgar score at 5th minute	5 minutes after delivery	Apgar score measured at 5th minute after delivery. Scores ranging from 1 to 10, with higher scores meaning a better outcome.
Admissions to a NICU	first 72 hours after delivery	Admissions to a NICU indicated by or related to some of the outcome measures

Trial Locations

Locations (1)

Orthogyn Medical and Dental Center; 🇧🇬 Sofia, Bulgaria