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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound following the SMFM guidelines | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of neonates who have composite neonatal adverse outcomes (CNAO) | from time of birth to 30 days after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Number of cesarean deliveries | at the time of delivery | |
| Number of participants for whom there was a deviation from the management protocol | from time of diagnosis of fetal growth restriction to delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hector Mendez-Figueroa, MD | Contact | 713-566-4674 | Hector.MendezFigueroa@uth.tmc.edu | |
| Sunbola S Ashimi Ademola | Contact | 713-500-6410 | Sunbola.S.Ashimi@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hector Mendez-Figueroa, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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|
| Ultrasound following the ISUOG guidelines | Other | 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. |
|
| 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) | 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 | at 5 minutes after birth |
| Number of participants that need mechanical ventilation | 6 hours after birth |
| 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 |
| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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