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

Primary Purpose

Fetal Growth Retardation

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ultrasound following the SMFM guidelines

Ultrasound following the ISUOG guidelines

About this trial

This is an interventional diagnostic trial for Fetal Growth Retardation focused on measuring antepartum surveillance

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines

Arm 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of cesarean deliveries

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

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

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

Number of participants with Apgar score < 7

Number of participants that need mechanical ventilation

Number of participants that show signs of neonatal seizure

Number of participants that have culture-proven neonatal sepsis

Number of participants that have intracranial hemorrhage

Number of participants that are still born or show neonatal death

Full Information

NCT ID

NCT05938829

First Posted

June 20, 2023

Last Updated

June 30, 2023

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT05938829

Brief Title

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

Acronym

FAME

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 1, 2023 (Anticipated)

Primary Completion Date

July 15, 2025 (Anticipated)

Study Completion Date

December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fetal Growth Retardation

Keywords

antepartum surveillance

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines

Arm Type

Other

Arm 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

Intervention Type

Other

Intervention Name(s)

Ultrasound following the SMFM guidelines

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Ultrasound following the ISUOG guidelines

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

from time of birth to 30 days after birth

Secondary Outcome Measure Information:

Title

Number of cesarean deliveries

Time Frame

at the time of delivery

Title

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

Time Frame

from time of diagnosis of fetal growth restriction to delivery

Title

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

Time Frame

from time of birth to 30 days after birth

Title

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

Description

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

Time Frame

from time of birth to 30 days after birth

Title

Number of participants with Apgar score < 7

Time Frame

at 5 minutes after birth

Title

Number of participants that need mechanical ventilation

Time Frame

6 hours after birth

Title

Number of participants that show signs of neonatal seizure

Time Frame

from time of birth to 30 days after birth

Title

Number of participants that have culture-proven neonatal sepsis

Time Frame

from time of birth to 30 days after birth

Title

Number of participants that have intracranial hemorrhage

Time Frame

from time of birth to 30 days after birth

Title

Number of participants that are still born or show neonatal death

Time Frame

from time of birth to 30 days after birth

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hector Mendez-Figueroa, MD

Phone

713-566-4674

Hector.MendezFigueroa@uth.tmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Sunbola S Ashimi Ademola

Phone

713-500-6410

Sunbola.S.Ashimi@uth.tmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hector Mendez-Figueroa, MD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hector Mendez-Figueroa, MD

Phone

713-566-4674

Hector.MendezFigueroa@uth.tmc.edu

First Name & Middle Initial & Last Name & Degree

Sunbola S Ashimi Ademola

Phone

713-500-6410

Sunbola.S.Ashimi@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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