Fetal Growth Restriction: Management Using Two Guidelines (FAME) - Fetal Growth Antenatal Management Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,100
- 试验地点
- 2
- 主要终点
- Number of neonates who have composite neonatal adverse outcomes (CNAO)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FGR diagnosed during sonographic examinations
- •estimated fetal weight less than or a fetal abdominal circumference less than the 10th percentile
排除标准
- •Multiple gestations with FGR
结局指标
主要结局
Number of neonates who have composite neonatal adverse outcomes (CNAO)
时间窗: from time of birth to 30 days after birth
次要结局
- 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)
研究者
Hector Mendez-Figueroa
Associate Professor
The University of Texas Health Science Center, Houston