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

NCT05938829 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2023-07-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Hector Mendez-Figueroa, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-07-15
Completion
2025-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05938829 on ClinicalTrials.gov