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

Fetal Growth Retardation Clinical Trial

— FAME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05938829
• Other study ID #: 2023-2012
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Hector Mendez-Figueroa, MD
• Phone: 713-566-4674
• Email: Hector.MendezFigueroa[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1100
• Est. completion date: December 1, 2025
• Est. primary completion date: July 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Retardation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of neonates who have composite neonatal adverse outcomes (CNAO)		from time of birth to 30 days after birth
Secondary	Number of cesarean deliveries		at the time of delivery
Secondary	Number of participants for whom there was a deviation from the management protocol		from time of diagnosis of fetal growth restriction to delivery
Secondary	Number of participants that are admitted to neonatal intensive care unit (NICU)		from time of birth to 30 days after birth
Secondary	Number of mothers who have composite maternal adverse outcomes (CMAO)	This includes estimated blood loss (EBL) / quantitative blood loss (QBL) > 1,000 mL, Transfusion, chorioamnionitis, ICU admission, or Maternal death	from time of birth to 30 days after birth
Secondary	Number of participants with Apgar score < 7		at 5 minutes after birth
Secondary	Number of participants that need mechanical ventilation		6 hours after birth
Secondary	Number of participants that show signs of neonatal seizure		from time of birth to 30 days after birth
Secondary	Number of participants that have culture-proven neonatal sepsis		from time of birth to 30 days after birth
Secondary	Number of participants that have intracranial hemorrhage		from time of birth to 30 days after birth
Secondary	Number of participants that are still born or show neonatal death		from time of birth to 30 days after birth