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Diastolic Deceleration Area in Early-onset SGR

Sponsor
Orthogyn Medical Center, Bulgaria (Other)
Overall Status
Recruiting
CT.gov ID
NCT05820464
Collaborator
(none)
300
Enrollment
1
Location
23.4
Anticipated Duration (Months)
12.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: DDA Doppler

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Diastolic Deceleration Area in Severe Early-onset Growth Restriction of the Fetus
Actual Study Start Date :
Apr 19, 2022
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Control group

Standard care is applied
DDA Doppler group

Standard care plus DDA Doppler monitoring

Diagnostic Test: 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]

  2. Anemia in the newborn [immediately after delivery]

Secondary Outcome Measures

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

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

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

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 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

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

None specified.

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:
NCT05820464
Other Study ID Numbers:
  • DDA1
First Posted:
Apr 19, 2023
Last Update Posted:
Apr 19, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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 Apr 19, 2023