Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus (TEAM LGA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of children with birthweight above 4500 grams
研究概览
简要总结
The purpose of this study is to compare the incidence of composite neonatal morbidity and birthweight >4500 grams among uncomplicated large for gestational age (LGA) fetal growth at delivered 37 weeks versus expectant management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy
- •Plan for vaginal delivery. Patients with prior cesarean section are eligible if they are planning for a trial of labor after cesarean section.
- •Gestational age 34 weeks 0 days to 37 weeks 0 days at time of enrollment
- •Dating of pregnancy by last menstrual period consistent with an ultrasound, ultrasound <21 weeks and 6 days of gestation, or known date of conception in the setting of in vitro fertilization
- •No known major anomalies (anomalies requiring surgery antenatally or in the neonatal period, anomalies not compatible with life as determined by the physician)
- •LGA defined as estimated fetal weight (EFW) > 90th percentile by Hadlock formula but <4500 grams
排除标准
- •Pre-gestational diabetes or gestational diabetes on medication (oral or insulin, excluding metformin)
- •Planned cesarean delivery
- •Polyhydramnios
- •Known major fetal anomalies
- •Multiple gestation or selective reduction of multiple gestation after 14 weeks
- •Previous stillbirth at term
- •Indications for delivery at <39 weeks. Common examples include:
- •Placenta previa
- •Placenta accreta
- •Vasa previa
- •History of classical cesarean section or myomectomy
- •Human immunodeficiency virus (HIV)
- •Oligohydramnios (low amniotic fluid, defined as maximum vertical pocket <2.0cm)
- •High-risk pregnancy as determined by the physician. Common examples include:
- •Pre-gestational diabetes or gestational diabetes on medication
- •Chronic hypertension on medication
- •Maternal cardiac disease
- •Asthma requiring oral steroids during pregnancy
- •Chronic renal disease
- •Antiphospholipid syndrome
- •Hyperthyroidism
- •Prior stillbirth
- •Systemic lupus erythematous
- •Hemoglobinopathies such as sickle cell disease
研究组 & 干预措施
Labor induction at 37.0 weeks to 37.6 weeks of gestation
Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days
干预措施: Labor induction at 37.0 weeks to 37.6 weeks of gestation (Procedure)
Expectant monitoring and delivery
Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices
干预措施: Expectant monitoring and delivery (Procedure)
结局指标
主要结局
Number of children with birthweight above 4500 grams
时间窗: Immediately at birth
Number of children presenting with CNM
时间窗: Up to 6 weeks after delivery
Composite neonatal morbidity (CNM) is any of the following: Apgar score \<5 at 5 minutes, seizure, fracture of skull, humerus, or clavicle, neonatal brachial plexus palsy, facial nerve palsy, oxygen supplementation \>4 hours, CPAP \>2 hours, mechanical ventilation, or death before discharge or IUFD.
次要结局
- Number of children delivered by cesarean section(Immediately at birth)
- Number of children admitted to NICU(Up to 6 weeks after delivery)
- Number of women presenting with CMM(Up to 6 weeks after delivery)
研究者
Bahaeddine M Sibai
Professor
The University of Texas Health Science Center, Houston