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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two different sets of guidelines for using ultrasounds to manage pregnancies affected by fetal growth restriction (FGR), a condition where a baby is smaller than expected in the womb. The goal is to determine which guideline more effectively reduces negative outcomes for the baby, such as post-birth complications, and for the mother, such as the need for a C-section. Participants must have a diagnosis of FGR, with their baby's weight or size below the 10th percentile. As an unphased trial, this study allows participants to contribute to important research that could enhance pregnancy care for FGR.

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 prior data suggests that these ultrasound guidelines are safe for managing fetal growth restriction?

Research has shown that using ultrasounds following the ISUOG and SMFM guidelines is generally safe for pregnant women. These guidelines help assess the baby's growth in the womb, especially if there are concerns about inadequate growth.

The ISUOG guidelines focus on accurately measuring the baby's size and growth, aiding doctors in determining the best time for delivery and reducing risks associated with slow growth.

Similarly, the SMFM guidelines offer an evidence-based approach to managing concerns about the baby's growth. They emphasize precise measurement and timing to ensure the baby's safety.

Both sets of guidelines effectively monitor the baby's growth and support informed decisions about care. While they differ slightly, both prioritize the baby's well-being and are generally well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different ultrasound guidelines for monitoring fetal growth restriction, which is a condition that can impact a baby's development. Unlike standard ultrasound practices, which may vary widely, this trial specifically compares the ISUOG (International Society of Ultrasound in Obstetrics and Gynecology) and SMFM (Society for Maternal-Fetal Medicine) guidelines. The trial's unique approach aims to determine which guideline offers more accuracy and reliability in detecting growth issues, potentially leading to better outcomes for mothers and babies. This could standardize care and improve early detection and intervention for fetal growth restriction.

What evidence suggests that these ultrasound guidelines are effective for managing fetal growth restriction?

This trial will compare the effectiveness of ultrasounds following the ISUOG guidelines with those following the SMFM guidelines for managing and diagnosing fetal growth restriction (FGR). Research has shown that both the ISUOG and SMFM ultrasound guidelines are effective in this regard. The ISUOG guidelines provide methods and standards for checking fetal growth, helping to spot problems early, and are known for their detailed measurement ranges and quality checks. In contrast, the SMFM guidelines use proven ultrasound techniques to define and manage FGR, focusing on practices backed by research for prenatal care. Studies indicate that these guidelines can help identify fetuses that are small but healthy, ensuring they receive appropriate care. Both sets of guidelines aim to improve outcomes for pregnancies with growth concerns. ^{1 3 6 7 8}

Who Is on the Research Team?

Hector Mendez-Figueroa, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. isuog.org isuog.org/static/b2aa3fb4-031e-4d84-b7246d613a466884/ISUOG-Practice-Guidelines-diagnosis-and-management-of-small-for-gestational-age-fetus-and-fetal-growth-restriction.pdf

diagnosis and management of small‐for‐gestational‐age ... The ISUOG Guidelines on ultrasound assess- ment of fetal biometry and growth describe methodology, reference ranges, growth standards and quality-control.

2. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1002/uog.27538

ISUOG Practice Guidelines: performance of third‐trimester ... The third-trimester ultrasound scan can assess fetal viability, presentation, anatomy and growth, amniotic fluid volume, placental location and ...

3. ajog.org ajog.org/article/S0002-9378(22)00477-X/fulltext

Reduced fetal growth velocity and weight loss are ... Reduced fetal growth velocity and weight loss are associated with adverse perinatal outcome in fetuses at risk of growth restriction.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12136975/

Fetal Growth Restriction: A Pragmatic Approach - PMC ISUOG defines FGR as EFW or AC < 3rd percentile or between the 3rd and 10th percentile with abnormal Doppler measurements of the uterine, umbilical, or middle ...

5. isuog.org isuog.org/static/d0d105b5-65b1-47f1-b4aa8b5e99afa1a6/ISUOG-Practice-Guidelines-ultrasound-fetal-biometry-growth.pdf

Ultrasound assessment of fetal biometry and growth These Guidelines aim to describe appropriate assessment of fetal biometry and diagnosis of fetal growth disorders. These disorders consist mainly of fetal ...

6. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/uog.23664

Diagnosis and management of fetal growth restriction: the ... ISUOG Practice Guidelines: ultrasound assessment of fetal biometry and growth. Ultrasound Obstet Gynecol 2019; 53: 715–723. 10.1002/uog ...

7. ajog.org ajog.org/article/S0002-9378(25)00273-X/fulltext

Monitoring and timing of delivery in suspected late fetal ... Antenatal ultrasound parameters were used to identify low-risk fetuses who could be delivered after 38 weeks of gestation vs high-risk fetuses delivered at 37 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12121231/

Slowing fetal growth velocity from the mid-trimester may ... Slowing fetal growth velocity identifies pregnancies at increased risk of poor outcomes. A slowing growth rate < − 0.13 z-scores/week may represent a pragmatic ...