Clinical trial NCT05938829: Fetal Growth Restriction: Management Using Two Guidelines - Fetal Growth Antenatal Management Evaluation
Official title: Fetal Growth Restriction: Management Using Two Guidelines (FAME) - Fetal Growth Antenatal Management Evaluation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fetal Growth Retardation
Keywords: antepartum surveillance
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 1100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of neonates who have composite neonatal adverse outcomes (CNAO)
timeFrame: from time of birth to 30 days after birth
Secondary outcomes:
measure: Number of cesarean deliveries
timeFrame: at the time of delivery
measure: Number of participants for whom there was a deviation from the management protocol
timeFrame: from time of diagnosis of fetal growth restriction to delivery
measure: Number of participants that are admitted to neonatal intensive care unit (NICU)
timeFrame: from time of birth to 30 days after birth
measure: Number of mothers who have composite maternal adverse outcomes (CMAO)
timeFrame: from time of birth to 30 days after birth
measure: Number of participants with Apgar score < 7
timeFrame: at 5 minutes after birth
measure: Number of participants that need mechanical ventilation
timeFrame: 6 hours after birth
measure: Number of participants that show signs of neonatal seizure
timeFrame: from time of birth to 30 days after birth
measure: Number of participants that have culture-proven neonatal sepsis
timeFrame: from time of birth to 30 days after birth
measure: Number of participants that have intracranial hemorrhage
timeFrame: from time of birth to 30 days after birth
measure: Number of participants that are still born or show neonatal death
timeFrame: from time of birth to 30 days after birth
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Hector Mendez-Figueroa, MD
role: PRINCIPAL_INVESTIGATOR
References: