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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 diagnosis of fetal growth restriction to delivery

Awards & highlights

FAME Trial 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.Check my eligibility

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.See study design

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.

FAME Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 5 minutes after birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 5 minutes after birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 minutes after birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of neonates who have composite neonatal adverse outcomes (CNAO)

Secondary outcome measures

Number of cesarean deliveries

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

Number of participants for whom there was a deviation from the management protocol

+7 more

FAME 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

903 Previous Clinical Trials

319,877 Total Patients Enrolled

Hector Mendez-Figueroa, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Ultrasound following the ISUOG guidelines (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05938829 — N/A

Fetal Growth Restriction Research Study Groups: Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines

Fetal Growth Restriction Clinical Trial 2023: Ultrasound following the ISUOG guidelines Highlights & Side Effects. Trial Name: NCT05938829 — N/A

Ultrasound following the ISUOG guidelines (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05938829 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently opportunities for individuals to join this experiment?

"Per the info listed on clinicaltrials.gov, this medical research is not recruiting patients at present. With a first post date of 7/1/2023 and last updated 6/30/2023, there are currently 23 other studies actively looking for volunteers to join them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fetal Growth Restriction: Management Using Two Guidelines - Fetal Growth Antenatal Management Evaluation

Hector Mendez-Figueroa 2023. "Fetal Growth Restriction: Management Using Two Guidelines - Fetal Growth Antenatal Management Evaluation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05938829.