Guideline-Based Ultrasounds for Fetal Growth Restriction (FAME Trial)

N/A

Waitlist Available

Led By Hector Mendez-Figueroa, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of birth to 30 days after birth

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing outcomes of pregnancies with fetal growth restriction managed with different ultrasound guidelines.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive ultrasounds following different guidelines rather than medication or surgery, there are no direct side effects associated with the interventions being tested.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of birth to 30 days after birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of birth to 30 days after birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of birth to 30 days after birth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Number of mothers who have composite maternal adverse outcomes (CMAO)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelinesExperimental Treatment2 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

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