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

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05938829
• Collaborator: (none)
• Enrollment: 1,100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 29
• Patients Per Site Per Month: 37.9

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Fetal Growth Retardation	Other: Ultrasound following the SMFM guidelines; Other: Ultrasound following the ISUOG guidelines	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Fetal Growth Restriction: Management Using Two Guidelines (FAME) - Fetal Growth Antenatal Management Evaluation
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jul 15, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm

Intervention/Treatment

Other: Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines 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

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.

Outcome Measures

Primary Outcome Measures

1. Number of neonates who have composite neonatal adverse outcomes (CNAO) [from time of birth to 30 days after birth]

Secondary Outcome Measures

1. Number of cesarean deliveries [at the time of delivery]

2. Number of participants for whom there was a deviation from the management protocol [from time of diagnosis of fetal growth restriction to delivery]

3. Number of participants that are admitted to neonatal intensive care unit (NICU) [from time of birth to 30 days after birth]

4. Number of mothers who have composite maternal adverse outcomes (CMAO) [from time of birth to 30 days after birth]

   This includes estimated blood loss (EBL) / quantitative blood loss (QBL) > 1,000 mL, Transfusion, chorioamnionitis, ICU admission, or Maternal death

5. Number of participants with Apgar score < 7 [at 5 minutes after birth]

6. Number of participants that need mechanical ventilation [6 hours after birth]

7. Number of participants that show signs of neonatal seizure [from time of birth to 30 days after birth]

8. Number of participants that have culture-proven neonatal sepsis [from time of birth to 30 days after birth]

9. Number of participants that have intracranial hemorrhage [from time of birth to 30 days after birth]

10. Number of participants that are still born or show neonatal death [from time of birth to 30 days after birth]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Hector Mendez-Figueroa, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hector Mendez-Figueroa, Associate Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT05938829
• Other Study ID Numbers: 2023-2012
• First Posted: Jul 11, 2023
• Last Update Posted: Jul 11, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hector Mendez-Figueroa, Associate Professor, The University of Texas Health Science Center, Houston: antepartum surveillance
• Additional relevant MeSH terms: Fetal Growth Retardation

Study Results

No Results Posted as of Jul 11, 2023