Fetal Growth RetardationNCT05295667
Doppler and AFV for Outcome Prediction ın FGR
An observational study of Fetal Growth Retardation, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigator contrived a prospective study of AUCR to compare its association to adverse perinatal outcomes with other established doppler parameters, such as CPR and UCR within a population of suspected FGR fetuses at term. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- Doppler measurement in combination with amniotic fluid volume
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 30 Jun 2020
- 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
- Adult
Study population: A pregnant womens between 18-40 years of age with singleton pregnancy after 37 weeks of gestational age with FGR
Who may be able to join
- SİNGLETON PREGNANCİES WİTH FGR FETUSES
- AFTER 37th GESTATİONAL WEEKS
Who cannot join
- SİNGLE OR MUTİPL FETAL ANOMALİES
- EVİDENCE OF İNTRAUTERİNE ENFECTİON
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Doppler Measurements With Amniotic Fluid Volume for the Predicition of Perinatal Outcome in FGR
The investigator contrived a prospective study of AUCR to compare its association to adverse perinatal outcomes with other established doppler parameters, such as CPR and UCR within a population of suspected FGR fetuses at term.
- Conditions
- Fetal Growth Retardation
- Being tested
- Doppler measurement in combination with amniotic fluid volume
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler measurement in combination with amniotic fluid volumeDiagnostic test
Ultrasonographic evaluation
| Study group | Role | What they receive |
|---|---|---|
| Fetal Growth Retardation Group | Not described Receives: Diagnostic Test: Doppler measurement in combination with amniotic fluid volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
the prediction power of adverse perinatal outcome with new doppler parameters ( such as AUCR)
enterence to neonatal intensive care unit and severe fetal acidemia ( pH: >7.10)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Jun 2020
- Primary completion1 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal Growth RetardationStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295667
- Sponsor's protocol ID
- Besimoglu01
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stumpfe FM, Faschingbauer F, Kehl S, Pretscher J, Emons J, Gass P, Mayr A, Schmid M, Beckmann MW, Stelzl P. Amniotic-Umbilical-to-Cerebral Ratio - A Novel Ratio Combining Doppler Parameters and Amniotic Fluid Volume to Predict Adverse Perinatal Outcome in SGA Fetuses At Term. Ultraschall Med. 2022 Apr;43(2):159-167. doi: 10.1055/a-1205-0161. Epub 2020 Jul 28.
PubMed 32722822
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Doppler Measurements With Amniotic Fluid Volume for the Predicition of Perinatal Outcome in FGR
- ClinicalTrials.gov ID
- NCT05295667
- Acronym / sponsor ID
- Besimoglu01
- Conditions
- Fetal Growth Retardation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases HospitalOther government
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 25 Mar 2022 (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.
The investigator contrived a prospective study of AUCR to compare its association to adverse perinatal outcomes with other established doppler parameters, such as CPR and UCR within a population of suspected FGR fetuses at term.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetal Growth Retardation Group | – | Diagnostic Test: Doppler measurement in combination with amniotic fluid volume |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- A pregnant womens between 18-40 years of age with singleton pregnancy after 37 weeks of gestational age with FGR
Key inclusion criteria (2 listed)
- SİNGLETON PREGNANCİES WİTH FGR FETUSES
- AFTER 37th GESTATİONAL WEEKS
Key exclusion criteria (2 listed)
- SİNGLE OR MUTİPL FETAL ANOMALİES
- EVİDENCE OF İNTRAUTERİNE ENFECTİON
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 |
|---|---|---|
| Doppler measurement in combination with amniotic fluid volumeUltrasonographic evaluation | Diagnostic test | Fetal Growth Retardation Group |
Primary outcome
the prediction power of adverse perinatal outcome with new doppler parameters ( such as AUCR)
Time frame: 1 year
enterence to neonatal intensive care unit and severe fetal acidemia ( pH: >7.10)
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 25 Mar 2022.
- Background: PubMed 32722822Stumpfe FM, Faschingbauer F, Kehl S, Pretscher J, Emons J, Gass P, Mayr A, Schmid M, Beckmann MW, Stelzl P. Amniotic-Umbilical-to-Cerebral Ratio - A Novel Ratio Combining Doppler Parameters and Amniotic Fluid Volume to Predict Adverse Perinatal Outcome in SGA Fetuses At Term. Ultraschall Med. 2022 Apr;43(2):159-167. doi: 10.1055/a-1205-0161. Epub 2020 Jul 28.
- Individual participant dataSharing planned: No
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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.
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 Fetal Growth Retardation, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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 25 Mar 2022. 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 Turkey (Türkiye). 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?
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?
the prediction power of adverse perinatal outcome with new doppler parameters ( such as AUCR) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05295667, which also lists 1 linked publication.
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 25 Mar 2022.