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

June 30, 2023 updated by: Hector Mendez-Figueroa, The University of Texas Health Science Center, Houston

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of neonates who have composite neonatal adverse outcomes (CNAO)
Time Frame: from time of birth to 30 days after birth
from time of birth to 30 days after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cesarean deliveries
Time Frame: at the time of delivery
at the time of delivery
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
from time of diagnosis of fetal growth restriction to delivery
Number of participants that are admitted to neonatal intensive care unit (NICU)
Time Frame: from time of birth to 30 days after birth
from time of birth to 30 days after birth
Number of mothers who have composite maternal adverse outcomes (CMAO)
Time Frame: 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
from time of birth to 30 days after birth
Number of participants with Apgar score < 7
Time Frame: at 5 minutes after birth
at 5 minutes after birth
Number of participants that need mechanical ventilation
Time Frame: 6 hours after birth
6 hours after birth
Number of participants that show signs of neonatal seizure
Time Frame: from time of birth to 30 days after birth
from time of birth to 30 days after birth
Number of participants that have culture-proven neonatal sepsis
Time Frame: from time of birth to 30 days after birth
from time of birth to 30 days after birth
Number of participants that have intracranial hemorrhage
Time Frame: from time of birth to 30 days after birth
from time of birth to 30 days after birth
Number of participants that are still born or show neonatal death
Time Frame: from time of birth to 30 days after birth
from time of birth to 30 days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

July 15, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 20, 2023

First Submitted That Met QC Criteria

June 30, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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