Diastolic Deceleration Area in Early-onset FGR

April 27, 2023 updated by: Petar Ignatov, Orthogyn Medical Center, Bulgaria

Diastolic Deceleration Area in Severe Early-onset Growth Restriction of the Fetus

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1606
        • Recruiting
        • Orthogyn Medical and Dental Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

No specific criteria, apart from the listed inclusion/exclusion ones

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Control group

Standard care:

  • Doppler velocimetry: UA & MCA PI, DV PIV, CPR;
  • Indirect cardiotocography (CTG)
  • Biophysical profile (BPP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anemia in the newborn
Time Frame: immediately after delivery
Hemoglobin deviation from GA mean - mild < 20 g/L, moderate - 20-70 g/L, severe > 70 g/L
immediately after delivery
Occurence of hypoxic-ischemic encephalopathy
Time Frame: first 72 hours after delivery
Occurence of hypoxic-ischemic encephalopathy in relation to some of the outcome measures
first 72 hours after delivery
Hypoxia in the newborn
Time Frame: immediately after delivery
Defined by pH values below 7.20 in the umbilical artery
immediately after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Admissions to a NICU
Time Frame: first 72 hours after delivery
Admissions to a NICU indicated by or related to some of the outcome measures
first 72 hours after delivery
Apgar score at 1st minute
Time Frame: 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.
1 minute after delivery
Apgar score at 5th minute
Time Frame: 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.
5 minutes after delivery
Apgar score at 10th minute
Time Frame: 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.
10 minutes after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthogyn Medical Center, Bulgaria

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2022

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDA1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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