NCT01594463已完成不适用
Third Trimester Routine Ultrasound in Low-risk Pregnancies : Comparison of Two Timing Periods Procedure for Screening Intrauterine Growth Restriction
University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 3,760 人开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,760
- 试验地点
- 2
- 主要终点
- Number of small for gestational age infant screened by a routine ultrasound in the third trimester (sensitivity).
研究概览
简要总结
Late intrauterine growth restriction is infrequently diagnosed with an overall sensitivity of 40 % in low-risk pregnancies. In addition, late intrauterine growth restriction may be associated with intrauterine death and poor neonatal outcomes i.e. birth asphyxia and hospitalization in intensive care unit. The investigators hypothesis that a later third trimester routine ultrasound may be more accurate to diagnose late intrauterine growth restriction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Accurate gestational dating using crown-rump length at 11-14 weeks
- •Singleton pregnancy
- •Primiparity
- •Normal First trimester (11-14 weeks) and second trimester (20-25 weeks) scans
- •Maternal age > 18 years
- •No maternal opposition for the study
排除标准
- •Maternal diseases i.e. chronic renal disease, hypertension, diabetes, collagen vascular disease, antiphospholipid syndrome
- •Pregnancies with congenital anomalies or foetal growth restriction diagnosed before 30 weeks of gestation
结局指标
主要结局
Number of small for gestational age infant screened by a routine ultrasound in the third trimester (sensitivity).
时间窗: At birth
SGA infant and intrauterine growth restriction are defined using a threshold below the tenth percentile for customized birth weight or customized estimated birth weight.
次要结局
- Number of neonate with a customized birth weight upper the tenth percentile adequately screened by a routine ultrasound in the third trimester (specificity).(At birth)
- Number of prenatal consultations, ultrasound scans performed, maternal hospitalization, labor induction, and caesarean section induced by the third trimester routine ultrasound(After the delivery)
- Maternal complications and neonatal outcomes.(In the postpartum period)
研究者
研究点 (2)
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