跳至主要内容
临床试验/NCT04212312
NCT04212312Unknown不适用

Repeat Versus Single Course of Betamethasone in Twin Pregnancies

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
1
主要终点
The incidence of respiratory morbidity after single versus repeat course of betamethasone for threatened preterm labor between 24-34 weeks' gestation

研究概览

简要总结

Thus far no robust data exist as to the effect of repeted course of antenatal corticosteroids in twin pregnancies. The investigators hypothesized that repeat course of betamethasone would further reduce neonatal morbidity in twins born before 34 weeks' gestation when compared with single dose.

详细描述

Observational data suggest benefits in multiple gestations exposed to antenatal corticosteroids, although these studies have not consistently reported a statistical benefit or the benefits achieved in singletons. Nevertheless, based on the improved outcomes reported in singleton gestations, one course of antenatal corticosteroids is administered to all patients who are between 24 weeks and 34 weeks of gestation and at risk of delivery within 7 days, irrespective of the fetal number. Moreover, "a repeat course" of antenatal corticosteroids should also be considered in women who are less than 34 weeks of gestation who have an imminent risk of preterm delivery within the next 7 days, and whose prior course of antenatal corticosteroids was administered more than 14 days previously, again, irrespective of the fetal number.

The objective of the current study is to evaluate fetal outcomes in twin pregnancies following repeat betamethasone administration during pregnancy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Study group - women who received 2 courses of betamethasone between 24 - 34 weeks' gestation.
  • Control comparison group - women who received 1 course of betamethasone between 24 - 34 weeks' gestation.

排除标准

  • singletone pregnancies
  • higher order multiple pregnancies (triplets and above)
  • known major congenital anomaly

结局指标

主要结局

The incidence of respiratory morbidity after single versus repeat course of betamethasone for threatened preterm labor between 24-34 weeks' gestation

时间窗: 1 year

The incidence of respiratory morbidity after single versus repeat course of betamethasone for threatened preterm labor between 24-34 weeks' gestation

次要结局

未报告次要终点

研究者

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

Yaniv Zipori MD

Principal Investigator

Rambam Health Care Campus

研究点 (1)

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