Fetal Growth Restriction: Management Using Two Guidelines (FAME) - Fetal Growth Antenatal Management Evaluation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fetal Growth Retardation
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 1100
- Locations
- 1
- Primary Endpoint
- Number of neonates who have composite neonatal adverse outcomes (CNAO)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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).
Investigators
Hector Mendez-Figueroa
Associate Professor
The University of Texas Health Science Center, Houston
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
Outcomes
Primary Outcomes
Number of neonates who have composite neonatal adverse outcomes (CNAO)
Time Frame: from time of birth to 30 days after birth
Secondary Outcomes
- Number of participants that need mechanical ventilation(6 hours after birth)
- Number of cesarean deliveries(at the time of delivery)
- Number of participants that are admitted to neonatal intensive care unit (NICU)(from time of birth to 30 days after birth)
- 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 mothers who have composite maternal adverse outcomes (CMAO)(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 have culture-proven neonatal sepsis(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 show signs of neonatal seizure(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)