Diastolic Deceleration Area in Late-onset FGR

• Sponsor: Orthogyn Medical Center, Bulgaria (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05837195
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 14.4
• Patients Per Site Per Month: 20.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxia; Anemia	Device: DDA Doppler

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Diastolic Deceleration Area (DDA) in Late-onset Fetal Growth Restriction (FGR)
• Actual Study Start Date: Apr 19, 2023
• Anticipated Primary Completion Date: Mar 30, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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	Device: DDA Doppler; A new Doppler parameter to quantify the amount of vasodilatation in the middle cerebral artery (MCA) and other blood vessels.

Outcome Measures

Primary Outcome Measures

1. Hypoxia in the newborn [immediately after delivery]

   Defined by pH values < 7.20

2. 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

3. 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

1. Apgar score at 1st minute [1 minute after delivery]

   Apgar score measured at 1st minute after delivery

2. Apgar score at 5th minute [5 minutes after delivery]

   Apgar score measured at 5th minute after delivery

3. Apgar score at 10th minute [10 minutes after delivery]

   Apgar score measured at 10th minute after delivery

4. Admissions to a NICU [first 72 hours after delivery]

   Admissions to a NICU indicated by or related to some of the outcome measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 48 Years
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orthogyn Medical and Dental Center	Sofia		Bulgaria	1606

Sponsors and Collaborators

• Orthogyn Medical Center, Bulgaria

Investigators

• Principal Investigator: Petar N Ignatov, PhD, Orthogyn Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Petar Ignatov, Assoc. prof. Petar Ignatov, M.D., Ph. D., Orthogyn Medical Center, Bulgaria
• ClinicalTrials.gov Identifier: NCT05837195
• Other Study ID Numbers: DDA2
• First Posted: May 1, 2023
• Last Update Posted: May 1, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypoxia

Study Results

No Results Posted as of May 1, 2023