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

NCT05938829 | Unknown

• 1 other identifier: 2023-2012
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

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).

Conditions

Fetal Growth Retardation

Keywords

antepartum surveillance

Outcome Measures

Primary Outcomes (1)

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

  from time of birth to 30 days after birth

Secondary Outcomes (10)

• Number of cesarean deliveries

  at the time of delivery

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

  from time of diagnosis of fetal growth restriction to delivery

• Number of participants that are admitted to neonatal intensive care unit (NICU)

  from time of birth to 30 days after birth

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

  from time of birth to 30 days after birth

• Number of participants with Apgar score < 7

  at 5 minutes after birth

Study Arms (1)

Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines

OTHER

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; Other: Ultrasound following the ISUOG guidelines

Interventions

Ultrasound following the SMFM guidelines OTHER

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 using SMFM guidelines, then ultrasound using ISUOG guidelines

Ultrasound following the ISUOG guidelines OTHER

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.

Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• FGR diagnosed during sonographic examinations
• estimated fetal weight less than or a fetal abdominal circumference less than the 10th percentile

You may not qualify if:

• Multiple gestations with FGR

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hector Mendez-Figueroa, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hector Mendez-Figueroa, MD

CONTACT

713-566-4674; Hector.MendezFigueroa@uth.tmc.edu

Sunbola S Ashimi Ademola

CONTACT

713-500-6410; Sunbola.S.Ashimi@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 11, 2023
• Study Start: July 1, 2023
• Primary Completion: July 15, 2025
• Study Completion: December 1, 2025
• Last Updated: July 11, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)