NCT03046355已完成不适用
Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women: A Randomized Controlled Trial (GROW Trial)
The University of Texas Health Science Center, Houston6 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2017年3月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- Number of children with birthweight less than the third percentile for gestational as assessed by NICHD nomograms
研究概览
简要总结
The goal of the study is to determine whether labor induction at 37 weeks of pregnancy can improve the baby's health at birth when compared with delivery at a later point in the pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •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)
- •FGR defined as estimated fetal weight (EFW) < 10th percentile by Hadlock formula with normal umbilical artery Doppler studies and normal amniotic fluid
排除标准
- •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
结局指标
主要结局
Number of children with birthweight less than the third percentile for gestational as assessed by NICHD nomograms
时间窗: Immediately at birth
NICHD is National Institute of Child Health and Human Development The NICHD nomogram will indicate their birth weight percentile based on their gestational age and ethnicity
次要结局
- Number of children presenting with CNM(Up to 6 weeks after delivery)
- 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)
- Number of children presenting with SGA(Immediately at birth)
研究者
Bahaeddine M Sibai
Professor
The University of Texas Health Science Center, Houston
研究点 (6)
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