NCT05938829

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

Fetal Growth Restriction: Management Using Two Guidelines (FAME) - Fetal Growth Antenatal Management Evaluation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 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

Interventions

Type	Name	Description
OTHER	Ultrasound following the SMFM guidelines	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.
OTHER	Ultrasound following the ISUOG guidelines	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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-07-15
• Completion: 2025-12-01
• First posted: 2023-07-11
• Last updated: 2023-07-11

Locations

1 site across 1 country: United States