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

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Fetal Growth Retardation

Treatments: Other: Ultrasound following the SMFM guidelines; Other: Ultrasound following the ISUOG guidelines

Study type: Interventional

Funder types: Other

Identifiers

NCT05938829

2023-2012

Details and patient eligibility

About

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).

Enrollment: 1,100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,100 participants in 1 patient group

Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines

Other group

Description:

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

Treatment:

Other: Ultrasound following the ISUOG guidelines

Other: Ultrasound following the SMFM guidelines