Fetal Growth Retardation
Conditions
Keywords
antepartum surveillance
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).
Interventions
OTHERUltrasound 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.
OTHERUltrasound 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
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of neonates who have composite neonatal adverse outcomes (CNAO) | from time of birth to 30 days after birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants for whom there was a deviation from the management protocol | from time of diagnosis of fetal growth restriction to delivery | — |
| Number of participants that are admitted to neonatal intensive care unit (NICU) | from time of birth to 30 days after birth | — |
| Number of mothers who have composite maternal adverse outcomes (CMAO) | 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 |
| Number of participants with Apgar score < 7 | at 5 minutes after birth | — |
| Number of cesarean deliveries | at the time of delivery | — |
| Number of participants that show signs of neonatal seizure | from time of birth to 30 days after birth | — |
| Number of participants that have culture-proven neonatal sepsis | from time of birth to 30 days after birth | — |
| Number of participants that have intracranial hemorrhage | from time of birth to 30 days after birth | — |
| Number of participants that are still born or show neonatal death | from time of birth to 30 days after birth | — |
| Number of participants that need mechanical ventilation | 6 hours after birth | — |
Countries
United States
Contacts
Primary ContactHector Mendez-Figueroa, MD
Backup ContactSunbola S Ashimi Ademola
Outcome results
None listed