FGRNCT04933396
FGR Diagnostic Criteria in Predicting Adverse Neonatal Outcomes
An observational study of FGR, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate using the recent consensus based definition for FGR using biometric and Doppler parameters to identify fetuses at risk of adverse perinatal outcomes compared to using solely biometric based parameter (EFW <10th percentile according to the Hadlock growth standard). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- FGR
- What is being tested?
- ultrasound diagnostic criteria
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 31 Dec 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: all pregnancies with FGR (EFW <10th percentile) who were admitted in Ain Shams University Maternity Hospital during the period from January 2016 till December 2020.
Who may be able to join
- Participants included in this study will have the following criteria:
- Pregnancies complicated with FGR (EFW <10th percentile).
- Singleton pregnancy.
Who cannot join
- • Fetal structural malformations or chromosomal abnormalities as detected by neonatal examination and anomaly scan during pregnancy.
- Identified infectious etiologies detected during immediate postnatal examination or during pregnancy.
- Gestational age cannot be calculated accurately.
- Missing antenatal or perinatal outcome data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of the Recent Consensus Based Definition of FGR Encompassing Biometric and Doppler Parameters in Predicting Adverse Neonatal Outcomes
The purpose of this study is to evaluate using the recent consensus based definition for FGR using biometric and Doppler parameters to identify fetuses at risk of adverse perinatal outcomes compared to using solely biometric based parameter (EFW <10th percentile according to the Hadlock growth standard).
- Conditions
- FGR
- Being tested
- ultrasound diagnostic criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound diagnostic criteriaDiagnostic test
evaluate using the recent consensus based definition for FGR using biometric and Doppler parameters to identify fetuses at risk of adverse perinatal outcomes compared to using solely biometric based parameter (EFW <10th percentile according to the Hadlock growth standard).
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
neonatal outcome
Measured: 30 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FGRStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Rasheedy Ali, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933396
- Sponsor's protocol ID
- Asu FM
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the Recent Consensus Based Definition of FGR Encompassing Biometric and Doppler Parameters in Predicting Adverse Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT04933396
- Acronym / sponsor ID
- Asu FM
- Conditions
- FGR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 21 Jun 2021 (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 purpose of this study is to evaluate using the recent consensus based definition for FGR using biometric and Doppler parameters to identify fetuses at risk of adverse perinatal outcomes compared to using solely biometric based parameter (EFW <10th percentile according to the Hadlock growth standard).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all pregnancies with FGR (EFW <10th percentile) who were admitted in Ain Shams University Maternity Hospital during the period from January 2016 till December 2020.
Key inclusion criteria (3 listed)
- Participants included in this study will have the following criteria:
Key exclusion criteria (4 listed)
- • Fetal structural malformations or chromosomal abnormalities as detected by neonatal examination and anomaly scan during pregnancy.
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 |
|---|---|---|
| ultrasound diagnostic criteriaevaluate using the recent consensus based definition for FGR using biometric and Doppler parameters to identify fetuses at risk of adverse perinatal outcomes compared to using solely biometric based parameter (EFW <10th percentile according to the Hadlock growth standard). | Diagnostic test | – |
Primary outcome
adverse events
Time frame: 30 days after delivery
neonatal outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- 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.
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 FGR, run by Ain Shams University at 1 site in Egypt.
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 4 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 21 Jun 2021. 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 Egypt. 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 Radwa Rasheedy, MD (01283492979 ext. 02, radwaebed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: 30 days 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 21 Jun 2021.