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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,100
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.
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.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Number of neonates who have composite neonatal adverse outcomes (CNAO)
Time frame: from time of birth to 30 days after birth
Number of cesarean deliveries
Time frame: 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
Number of participants that are admitted to neonatal intensive care unit (NICU)
Time frame: from time of birth to 30 days after birth
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
Time frame: from time of birth to 30 days after birth
Number of participants with Apgar score < 7
Time frame: at 5 minutes after birth
Number of participants that need mechanical ventilation
Time frame: 6 hours after birth
Number of participants that show signs of neonatal seizure
Time frame: 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
Number of participants that have intracranial hemorrhage
Time frame: 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
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