Guideline-Based Ultrasounds for Fetal Growth Restriction

(FAME Trial)

Overseen By Hector Mendez-Figueroa, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Multiple gestations

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Ultrasound following the ISUOG guidelines, Ultrasound following the SMFM guidelines for fetal growth restriction?

Research comparing the SMFM and ISUOG guidelines shows that both can predict small size at birth and other negative outcomes in newborns, suggesting that using these guidelines for ultrasounds can help identify babies at risk of growth issues. ^{1 2 3 4 5}

Is ultrasound safe for monitoring fetal growth restriction?

Ultrasound, when used to monitor fetal growth restriction, is generally considered safe for both the mother and the baby. It is a common tool used in pregnancy to check the baby's growth and health, and there is no evidence from the provided research articles suggesting any safety concerns. ^{1 3 5 6 7}

How does the ultrasound treatment for fetal growth restriction differ from other treatments?

This treatment is unique because it uses ultrasound following specific guidelines from the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) and the Society for Maternal-Fetal Medicine (SMFM) to monitor fetal growth restriction. These guidelines provide different criteria for identifying and managing fetal growth issues, which can help in predicting and improving outcomes for affected babies. ^{1 2 3 8 9}

What is the purpose of this trial?

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).

Research Team

Hector Mendez-Figueroa, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for pregnant individuals with a diagnosis of Fetal Growth Restriction (FGR), identified through ultrasound, where the estimated fetal weight or abdominal circumference is below the 10th percentile. It's not open to those expecting multiples with FGR.

Inclusion Criteria

FGR diagnosed during sonographic examinations

Estimated fetal weight less than or a fetal abdominal circumference less than the 10th percentile

Exclusion Criteria

Multiple gestations with FGR

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SMFM Guidelines Treatment

Participants are managed using the Society of Maternal-Fetal Medicine (SMFM) guidelines

12 months

Washout Period

A 2-week washout period between guideline management phases

2 weeks

ISUOG Guidelines Treatment

Participants are managed using the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) guidelines

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ultrasound following the ISUOG guidelines
• Ultrasound following the SMFM guidelines

Trial Overview The study compares two sets of guidelines for managing FGR during pregnancy: one by ISUOG and another by SMFM. The focus is on how each affects newborn health outcomes, cesarean delivery rates, NICU admissions, and maternal health.

Participant Groups

Group I: Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Outcome-based comparison of SMFM and ISUOG definitions of fetal growth restriction. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Ultrasound prediction of adverse perinatal outcome at diagnosis of late-onset fetal growth restriction. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Intracranial ultrasound abnormalities and mortality in preterm infants with and without fetal growth restriction stratified by fetal Doppler study results. [2023]

4. Colombia pubmed.ncbi.nlm.nih.gov

Predictive performance of fetal growth restriction criteria for adverse perinatal outcomes in a hospital in Popayán, Colombia [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Screening for fetal growth restriction: a mathematical model of the effect of time interval and ultrasound error. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Doppler US in the Evaluation of Fetal Growth and Perinatal Health. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

External Validation of a Prediction Model Assessing Risk of Delivery in Fetuses with Growth Restriction after Diagnosis of Abnormal Umbilical Artery Doppler. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Detection of fetal growth restriction with preterm severe preeclampsia: experience at two tertiary centers. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Ultrasound screening for fetal growth restriction at 36 vs 32 weeks' gestation: a randomized trial (ROUTE). [2016]