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临床试验/NCT01772381
NCT01772381已完成不适用

Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean

Ain Shams Maternity Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
1
主要终点
Special care baby unit

研究概览

简要总结

Introduction: Babies born at term by elective caesarean section (CS) and before onset of labor are more likely to develop respiratory complications than babies born vaginally. In developing countries resources are scarce and it is difficult to provide expensive treatments as neonatal care.

Aim of the Work: To assess the effect of prophylactic dexamethasone administration before elective cesarean section at term in reducing neonatal respiratory complications.

Patients and methods: 600 women were included in the study and were planned to have elective caesarean section. 300 received dexamethasone 12 mg twice, 12 hours apart 48 hours before delivery. 300 patients were the control group.

The outcomes were: incidence of admission to neonatal intensive care unit (NICU), incidence of transient tachypnea of newborn (TTN), the incidence of respiratory distress syndrome (RDS) and the need for mechanical ventilation.

详细描述

Dexamethasone which is a long acting corticosteroid can be used prior to elective cesarean section to decrease neonatal respiratory morbidity by enhacing fetal lung maturity.

研究设计

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

入排标准

年龄范围
22 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Previous caesarean section
  • Complete 37 week calculated from the first day of the last menstrual period.

排除标准

  • Obstetric complications such as pre-eclampsia, antepartum hemorrhage or known fetal anomaly.
  • Hypertensive patients.
  • Chronic disease e.g. diabetes mellitus.
  • Known renal disease.
  • Pre-operative infection.

研究组 & 干预措施

Dexamethasone

Experimental

Dexamethasone, im , 12 mg twice, 12 hrs apart, 48 hrs before elective cesarean section

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Special care baby unit

时间窗: 24 hours

Special care baby unit admission for babies with respiratory distress

次要结局

  • Severity of respiratory distress(24 hours)

研究者

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

Noha Rabei

Assistant Professor, Obstetrics and Gynecology

Ain Shams Maternity Hospital

研究点 (1)

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