Fetal Growth RetardationFAMENCT05938829
Fetal Growth Restriction: Management Using Two Guidelines - Fetal Growth Antenatal Management Evaluation
A study testing Ultrasound following the SMFM guidelines and Ultrasound following the ISUOG guidelines in people with Fetal Growth Retardation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to compare the composite neonatal adverse outcomes (CNAO) among pregnancies complicated by fetal growth restriction (FGR) managed using the Society of Maternal-Fetal Medicine (SMFM) versus International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) antepartum ultrasound… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- Ultrasound following the SMFM guidelines and Ultrasound following the ISUOG guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 1 Dec 2025
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- FGR diagnosed during sonographic examinations
- estimated fetal weight less than or a fetal abdominal circumference less than the 10th percentile
Who cannot join
- Multiple gestations with FGR
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Hector Mendez-Figueroa, MD, 713-566-4674, Hector.MendezFigueroa@uth.tmc.edu
Sunbola S Ashimi Ademola, 713-500-6410, Sunbola.S.Ashimi@uth.tmc.edu
About this study
Official title: Fetal Growth Restriction: Management Using Two Guidelines (FAME) - Fetal Growth Antenatal Management Evaluation
The purpose of this study is to compare the composite neonatal adverse outcomes (CNAO) among pregnancies complicated by fetal growth restriction (FGR) managed using the Society of Maternal-Fetal Medicine (SMFM) versus International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) antepartum ultrasound guidelines, to measure the rate of the individual components of CNAO, to record the rate of cesarean delivery during labor, to tabulate the rate of deviation from the management protocol assigned at the time of evaluation, to record neonatal intensive care unit (NICU) admission rates and to measure the rate of the composite maternal adverse outcome (CMAO).
- Conditions
- Fetal Growth Retardation
- Being tested
- Ultrasound following the SMFM guidelines, Ultrasound following the ISUOG guidelines
- Keywords
- antepartum surveillance
- 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.
Ultrasound following the SMFM guidelinesOther
Patients will be followed with weekly ultrasound. During these scans, the patient will have a biophysical profile, a non-stress test (if the gestational age is over 32 weeks), and a Doppler interrogation of the fetal umbilical artery. This information will be captured in our ultrasound reporting software, Viewpoint.
Ultrasound following the ISUOG guidelinesOther
Patients will be followed with weekly ultrasound. During these scans, the patient will have a biophysical profile, a non-stress test (if the gestational age is over 32 weeks), and a Doppler interrogation of the fetal umbilical artery, middle cerebral artery, and ductus venosus. This information will be captured in our ultrasound reporting software, Viewpoint.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines | Other | Each site will utilize SMFM guidelines for the first 12 months and then there will be a 2 week washout period, after which each site will utilize ISUOG guidelines for 12 months Receives: Other: Ultrasound following the SMFM guidelines; Other: Ultrasound following the ISUOG guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of neonates who have composite neonatal adverse outcomes (CNAO)
Measured: from time of birth to 30 days after birth
Secondary outcomes (10)
Number of cesarean deliveries
Measured: at the time of delivery
Number of participants for whom there was a deviation from the management protocol
Measured: from time of diagnosis of fetal growth restriction to delivery
Number of participants that are admitted to neonatal intensive care unit (NICU)
Measured: from time of birth to 30 days after birth
Number of mothers who have composite maternal adverse outcomes (CMAO)
This includes estimated blood loss (EBL) / quantitative blood loss (QBL) > 1,000 mL, Transfusion, chorioamnionitis, ICU admission, or Maternal death
Measured: from time of birth to 30 days after birth
Number of participants with Apgar score < 7
Measured: at 5 minutes after birth
Number of participants that need mechanical ventilation
Measured: 6 hours after birth
Number of participants that show signs of neonatal seizure
Measured: from time of birth to 30 days after birth
Number of participants that have culture-proven neonatal sepsis
Measured: from time of birth to 30 days after birth
Number of participants that have intracranial hemorrhage
Measured: from time of birth to 30 days after birth
Number of participants that are still born or show neonatal death
Measured: from time of birth to 30 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hector Mendez-Figueroa, The University of Texas Health Science Center, Houston
- Investigators
- Hector Mendez-Figueroa, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938829
- Sponsor's protocol ID
- 2023-2012
- Acronym
- FAME
- Status last verified
- Jun 2023
- First submitted
- 20 Jun 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- 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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Growth Restriction: Management Using Two Guidelines (FAME) - Fetal Growth Antenatal Management Evaluation
- ClinicalTrials.gov ID
- NCT05938829
- Acronym / sponsor ID
- FAME / 2023-2012
- Conditions
- Fetal Growth Retardation
- Keywords
- antepartum surveillance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Jul 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.
The purpose of this study is to compare the composite neonatal adverse outcomes (CNAO) among pregnancies complicated by fetal growth restriction (FGR) managed using the Society of Maternal-Fetal Medicine (SMFM) versus International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) antepartum ultrasound guidelines, to measure the rate of the individual components of CNAO, to record the rate of cesarean delivery during labor, to tabulate the rate of deviation from the management protocol assigned at the time of evaluation, to record neonatal intensive care unit (NICU) admission rates and to measure the rate of the composite maternal adverse outcome (CMAO).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines | Other | Other: Ultrasound following the SMFM guidelines, Other: Ultrasound following the ISUOG guidelinesEach site will utilize SMFM guidelines for the first 12 months and then there will be a 2 week washout period, after which each site will utilize ISUOG guidelines for 12 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- FGR diagnosed during sonographic examinations
- estimated fetal weight less than or a fetal abdominal circumference less than the 10th percentile
Key exclusion criteria (1 listed)
- Multiple gestations with FGR
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 following the SMFM guidelinesPatients will be followed with weekly ultrasound. During these scans, the patient will have a biophysical profile, a non-stress test (if the gestational age is over 32 weeks), and a Doppler interrogation of the fetal umbilical artery. This information will be captured in our ultrasound reporting software, Viewpoint. | Other | Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines |
| Ultrasound following the ISUOG guidelinesPatients will be followed with weekly ultrasound. During these scans, the patient will have a biophysical profile, a non-stress test (if the gestational age is over 32 weeks), and a Doppler interrogation of the fetal umbilical artery, middle cerebral artery, and ductus venosus. This information will be captured in our ultrasound reporting software, Viewpoint. | Other | Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines |
Primary outcome
Number of neonates who have composite neonatal adverse outcomes (CNAO)
Time frame: from time of birth to 30 days after birth
10 secondary outcomes
Number of cesarean deliveries
Time frame: at the time of delivery
Number of participants for whom there was a deviation from the management protocol
Time frame: from time of diagnosis of fetal growth restriction to delivery
Number of participants that are admitted to neonatal intensive care unit (NICU)
Time frame: from time of birth to 30 days after birth
Number of mothers who have composite maternal adverse outcomes (CMAO)
Time frame: from time of birth to 30 days after birth
Number of participants with Apgar score < 7
Time frame: at 5 minutes after birth
Number of participants that need mechanical ventilation
Time frame: 6 hours after birth
Number of participants that show signs of neonatal seizure
Time frame: from time of birth to 30 days after birth
Number of participants that have culture-proven neonatal sepsis
Time frame: from time of birth to 30 days after birth
Number of participants that have intracranial hemorrhage
Time frame: from time of birth to 30 days after birth
Number of participants that are still born or show neonatal death
Time frame: from time of birth to 30 days after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- 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.
Hector Mendez-Figueroa, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound following the SMFM guidelines and Ultrasound following the ISUOG guidelines in people with Fetal Growth Retardation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 1 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 11 Jul 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 United States. 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 Hector Mendez-Figueroa, MD (713-566-4674, Hector.MendezFigueroa@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of neonates who have composite neonatal adverse outcomes (CNAO) (time frame: from time of birth to 30 days after birth). 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 11 Jul 2023.