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临床试验/NCT02719886
NCT02719886Unknown不适用

Timing of Serial UltrasouNds in High-Risk Pregnancies: A Randomized Controlled Trial

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
228
试验地点
2
主要终点
Frequency of detection of fetal growth abnormalities, starting at 28 weeks gestational age

研究概览

简要总结

The purpose of this randomized controlled trial is to compare the frequency of the diagnosis of fetal growth abnormalities when ultrasound assessment is performed at 2 versus 4 week intervals.

详细描述

While there is an agreement that women at risk for abnormalities of fetal growth should have serial ultrasound examinations in the 3rd trimester, there is a lack of consensus on how frequently these exams should be done. The American College of Obstetrics and Gynecology recommend that an ultrasound to assess fetal growth be performed between 2 to 4 weeks; however, there have been no prospective or randomized trials to determine whether the optimal interval should be closer to 2 weeks or delayed to 4 weeks. Currently, only 60% of fetuses' with abnormal growth are detected antenatally. There is equipoise of whether ultrasound every 2 versus 4 weeks improves the detection and subsequent newborn outcomes or merely leads to an increase in false positives and unnecessary interventions. It has been proposed, that if delivery occurs within 2 weeks of the ultrasound, the antenatal detection of abnormal growth may be more accurate and hence more likely to improve outcomes. Conversely, a shorter interval may result in confusion as to whether there is actual change in growth or merely variation in the measurement technique itself. Moreover, with the cost of ultrasound averaging approximately $200 per examination, the interval between ultrasounds can have major implications on public-health costs as well as the interventions that subsequently follow if an abnormality is detected.

The purpose of this randomized controlled trial is to compare the frequency of the diagnosis of fetal growth abnormalities when ultrasound assessment is performed at 2 versus 4 week intervals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Maternal age ≥ 18 years
  • Singletons
  • Gestational age ≥ 20 weeks to 27 weeks 6 days
  • Has insurance, whether private or government issued
  • High-risk pregnancy requiring serial fetal growth assessment as determined by the treating physician.
  • Dating of pregnancy by ultrasound ≤ 21 weeks and 6 days of gestation or known date of conception in the setting of in vitro fertilization
  • No known major anomalies

排除标准

  • Known major fetal anomaly
  • Multiple gestation (twins or triplets)

结局指标

主要结局

Frequency of detection of fetal growth abnormalities, starting at 28 weeks gestational age

时间窗: up to 72 hours after delivery

次要结局

  • Frequency of detection of amniotic fluid abnormality, starting at 28 weeks gestational age(Up to 72 hours after delivery)
  • Composite neonatal morbidity (CNM)(up to 72 hours from neonatal discharge from hospital)
  • Composite maternal morbidity (CMM)(up to 72 hours from mother's discharge from hospital)
  • Birthweight compared to antenatal estimated fetal weights(At delivery)
  • Cost of interventions resulting from detection of abnormal growth or amniotic fluid(up to 72 hours from neonatal discharge from hospital)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robyn Roberts

Fellow

The University of Texas Health Science Center, Houston

研究点 (2)

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