HypoxiaNCT05820464
Diastolic Deceleration Area in Early-onset FGR
An observational study of Hypoxia and Anemia, run by Orthogyn Medical Center, Bulgaria at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- What is being tested?
- DDA Doppler
- How many people
- 300 participants
- Where
- 1 siteBulgaria
- Study dates
- 19 Apr 2022to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Adult
Study population: No specific criteria, apart from the listed inclusion/exclusion ones
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site, 1 recruiting
- Recruiting
Orthogyn Medical and Dental Center
Sofia, 1606
Petar N Ignatov, 0888963189, ignatov@orthogyn.com
About this study
Official title: 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.
- Being tested
- DDA Doppler
- Medical subject headings
- Hypoxia, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDA DopplerDiagnostic test
A new Doppler parameter to quantify the amount of vasodilatation in the middle cerebral artery (MCA) and other blood vessels.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: DDA Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxia in the newborn
Defined by pH values below 7.20 in the umbilical artery
Measured: immediately after delivery
Anemia in the newborn
Hemoglobin deviation from GA mean - mild < 20 g/L, moderate - 20-70 g/L, severe > 70 g/L
Measured: immediately after delivery
Occurence of hypoxic-ischemic encephalopathy
Occurence of hypoxic-ischemic encephalopathy in relation to some of the outcome measures
Measured: first 72 hours after delivery
Secondary outcomes (4)
Apgar score at 1st minute
Apgar score measured at 1st minute after delivery. Scores ranging from 1 to 10, with higher scores meaning a better outcome.
Measured: 1 minute after delivery
Apgar score at 5th minute
Apgar score measured at 5th minute after delivery. Scores ranging from 1 to 10, with higher scores meaning a better outcome.
Measured: 5 minutes after delivery
Apgar score at 10th minute
Apgar score measured at 10th minute after delivery. Scores ranging from 1 to 10, with higher scores meaning a better outcome.
Measured: 10 minutes after delivery
Admissions to a NICU
Admissions to a NICU indicated by or related to some of the outcome measures
Measured: first 72 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start19 Apr 2022
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthogyn Medical Center, Bulgaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petar Ignatov, Orthogyn Medical Center, Bulgaria
- Investigators
- Petar N Ignatov, PhD, Principal investigator, Orthogyn Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820464
- Sponsor's protocol ID
- DDA1
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diastolic Deceleration Area in Severe Early-onset Growth Restriction of the Fetus
- ClinicalTrials.gov ID
- NCT05820464
- Acronym / sponsor ID
- DDA1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Orthogyn Medical Center, BulgariaUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Standard care: * Doppler velocimetry: UA \& MCA PI, DV PIV, CPR; * Indirect cardiotocography (CTG) * Biophysical profile (BPP) |
| DDA Doppler group | – | Diagnostic Test: DDA DopplerStandard care plus DDA Doppler monitoring |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- No specific criteria, apart from the listed inclusion/exclusion ones
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DDA DopplerA new Doppler parameter to quantify the amount of vasodilatation in the middle cerebral artery (MCA) and other blood vessels. | Diagnostic test | DDA Doppler group |
Primary outcome
Hypoxia in the newborn
Time frame: immediately after delivery
Defined by pH values below 7.20 in the umbilical artery
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
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
4 secondary outcomes
Apgar score at 1st minute
Time frame: 1 minute after delivery
Apgar score at 5th minute
Time frame: 5 minutes after delivery
Apgar score at 10th minute
Time frame: 10 minutes after delivery
Admissions to a NICU
Time frame: first 72 hours after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Undecided
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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
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RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petar N Ignatov, PhD principal investigator
Orthogyn Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia and Anemia, run by Orthogyn Medical Center, Bulgaria at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petar N Ignatov, PhD (+359888963189, ignatov@orthogyn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxia in the newborn (time frame: immediately after delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.