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临床试验/NCT03057717
NCT03057717已完成不适用

The Effect of Antenatal Corticosteroids on the Fetal Thymus - a Possible Role in Fetal Immune

Unity Health Toronto0 个研究点目标入组 86 人开始时间: 2010年8月20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
86
主要终点
Fetal Thymus Size

研究概览

简要总结

Administration of corticosteroids is standard practice for pregnant patients at risk of preterm labour to reduce the risk of neonatal respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis and neonatal mortality. However, there is an unknown effect of antenatal steroids on both fetal and neonatal immune function. The purpose of this study is to demonstrate the effect of antenatal steroids on the size of the fetal thymus gland.

详细描述

Women with a singleton pregnancy in the twenty-forth to thirty-fourth week of gestation who are at risk for preterm labour, requiring the administration of Betamethasone twelve milligrams intramuscularly every twenty-four hours for two doses will be included in this study along with an equal number of gestational-age matched controls not at risk for preterm delivery and therefore not requiring the administration of Betamethasone. A 2-D ultrasound assessment of the fetal thymus size with measurements of the maximum transverse diameter and thymus perimeter in the three-vessel view will be performed as a baseline measurement within 36 hours of the administration of the first dose of corticosteroids. For each patient enrolled, a gestational-age matched control will have a similar ultrasound assessment. These measurements will be repeated 2 weeks after the first baseline ultrasound, and then only patients who received corticosteroids will have subsequent ultrasound measurements every 2 weeks until delivery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women with a singleton pregnancy in the twenty-forth to thirty-fourth week of gestation who are at risk for preterm labour, requiring the administration of Betamethasone twelve milligrams intramuscularly every twenty-four hours for two doses will be included in this study along with an equal number of gestational-age matched controls not at risk for preterm delivery and therefore not requiring the administration of Betamethasone.

排除标准

  • chronic use of steroids during pregnancy for other indications
  • delivery less than 1 week from enrollment
  • confirmed chorioamnionitis or preterm premature rupture of membranes.

结局指标

主要结局

Fetal Thymus Size

时间窗: 24 weeks gestation to delivery

Fetal thymus size for pregnant women given Betamethasone compared to fetal thymus size for pregnant women not given Betamethasone

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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