Late-onset Fetal Growth RestrictionNCT04447248
qCTG and Doppler Ultrasound in the Detection of Hypoxia Among FGR Fetuses
An observational study of Late-onset Fetal Growth Restriction, run by Orthogyn Medical Center, Bulgaria.
Trial summary
To evaluate the benefits of combining Doppler measurements of placental/fetal blood vessels with computerized cardiotocography (quantitative cardiotocogrpahy - qCTG) in the detection of fetal hypoxia (pH < 7.20) among late-onset growth restricted (SGR) fetuses Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Late-onset Fetal Growth Restriction
- What is being tested?
- QDSP Protocol
- Type of treatment
- Medical device
- How many people
- 1,714 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2011to 7 Oct 2019
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Bulgarian population (caucasian)
Who may be able to join
- estimated fetal weight below the 10th centile of the reference curve for the Bulgarian population (11);
- absence of sonographic and laboratory evidence of structural anomalies;
- absence of severe maternal complications;
- documented birth weight < 10th centile;
- full follow-up documentation
Who cannot join
- multiple pregnancies;
- congenital malformations and any chromosomal malformations known before labor and delivery;
- severe maternal complications;
- documented birth weight > 10th centile;
- pregnancy loss;
- failure to obtain full follow-up documentation
About this study
Official title: Quantitative Cardiotocography and Doppler Ultrasound in the Detection of Hypoxia Among Growth-restricted Fetuses
To evaluate the benefits of combining Doppler measurements of placental/fetal blood vessels with computerized cardiotocography (quantitative cardiotocogrpahy - qCTG) in the detection of fetal hypoxia (pH < 7.20) among late-onset growth restricted (SGR) fetuses
- Conditions
- Late-onset Fetal Growth Restriction
- Being tested
- QDSP Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QDSP ProtocolDevice
Computerized expert system for fetal monitoring, based on cardiotocogrpaphy
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of hypoxia (pH<7.20) at birth
Measured: up to 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start5 May 2011
- Primary completion7 Oct 2019
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late-onset Fetal Growth RestrictionStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,714 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447248
- Sponsor's protocol ID
- QDSP Protocol
- Status last verified
- Jul 2020
- First submitted
- 23 Jun 2020
- Last updated
- 7 Jul 2020
- 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 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Cardiotocography and Doppler Ultrasound in the Detection of Hypoxia Among Growth-restricted Fetuses
- ClinicalTrials.gov ID
- NCT04447248
- Acronym / sponsor ID
- QDSP Protocol
- Conditions
- Late-onset Fetal Growth Restriction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,714 participants (actual)
- Lead sponsor
- Orthogyn Medical Center, BulgariaUniversity, hospital or other
- Study start
- 5 May 2011 (actual)
- Primary completion
- 7 Oct 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 25 Jun 2020 (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.
To evaluate the benefits of combining Doppler measurements of placental/fetal blood vessels with computerized cardiotocography (quantitative cardiotocogrpahy - qCTG) in the detection of fetal hypoxia (pH < 7.20) among late-onset growth restricted (SGR) fetuses
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Bulgarian population (caucasian)
Key inclusion criteria (5 listed)
- estimated fetal weight below the 10th centile of the reference curve for the Bulgarian population (11);
- absence of sonographic and laboratory evidence of structural anomalies;
- absence of severe maternal complications;
- documented birth weight < 10th centile;
- full follow-up documentation
Key exclusion criteria (6 listed)
- multiple pregnancies;
- congenital malformations and any chromosomal malformations known before labor and delivery;
- severe maternal complications;
- documented birth weight > 10th centile;
- pregnancy loss;
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 |
|---|---|---|
| QDSP ProtocolComputerized expert system for fetal monitoring, based on cardiotocogrpaphy | Device | – |
Primary outcome
Occurence of hypoxia (pH<7.20) at birth
Time frame: up to 5 minutes after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Late-onset Fetal Growth Restriction, run by Orthogyn Medical Center, 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of hypoxia (pH<7.20) at birth (time frame: up to 5 minutes after delivery). 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 7 Jul 2020.