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

Study Overview
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Brief Summary
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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).

Official Title
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Fetal Growth Restriction: Management Using Two Guidelines (FAME) - Fetal Growth Antenatal Management Evaluation

Conditions
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Fetal Growth Retardation

Intervention / Treatment
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* Other: Ultrasound following the SMFM guidelines
* Other: Ultrasound following the ISUOG guidelines


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines<br>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 | Other: Ultrasound following the SMFM guidelines<br>* 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.<br>Other: Ultrasound following the ISUOG guidelines<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of neonates who have composite neonatal adverse outcomes (CNAO) |  | from time of birth to 30 days after birth | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antepartum surveillance