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临床试验/NCT04816097
NCT04816097Unknown4 期

Role of Prophylactic Dexamethasone Administration Before Elective Cesarean Section at Term in Reducing the Incidence of Neonatal Respiratory Distress Syndrome (A Randomized Controlled Trial)

Ain Shams University0 个研究点目标入组 950 人开始时间: 2021年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
950
主要终点
incidence of neonatal respiratory distress syndrome (RDS)

研究概览

简要总结

Prophylactic antenatal administration of corticosteroid enhance fetal lung maturity and reduce the probability of respiratory morbidity in preterm births.

assessment of administration of four doses intramuscular dexamethasone 48h before elective cesarean section at term in reducing the incidence of neonatal respiratory distress syndrome and NICU admission as a result

详细描述

Term neonates born between (37-39 wks) by elective cesarean section are likely to develop respiratory distress syndrome more than neonates born by vaginal delivery, and this risk increases for the subgroup of neonates born after elective caeserean section , i.e. before onset of labour , , with potentially severe implications The risk is decreasing with advanced gestational age and neonates born in 37 weeks are at 1.7 times more than those born at 38 weeks , which in turn are at 2.4 times more than those born at 39 weeks If the pregnant female is given four intramuscular injections of 6 mg of dexamethasone , 48 hrs before elective caesarean section decreases the neonatal respiratory morbidity. Five studies lasting between 3 to 20 years with more than 1500 patients have shown no adverse effect of single course of antenatal corticosteroid , neither through infection of the fetus or mother nor in long term neurological or cognitive effect According to Cochrane Database of Systematic Reviews 2018 , prophylactic administration of antenatal corticosteroids appeared to reduce the rate of RDS by approximately 52%. It also reduced the need for NICU admission, both due to respiratory morbidity (by approximately 58%) and for any indication. The reduction of NICU admissions due to respiratory reasons is consistent with the reduction of respiratory morbidity after corticosteroid administration

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Gestational age (37-39wks).
  • Singleton pregnancy.
  • Didn't receive any steroid treatment during pregnancy.

排除标准

  • Undetermined gestational age
  • Maternal chronic diseases (e.g: hypertension, DM-2) to avoid any side effects of steroid use and to keep the pregnant 's case from getting worse.
  • Congenital fetal malformations
  • Emergency CS
  • Pregnant refusing to participate in the study or unable to consent

研究组 & 干预措施

Steroid Group

Active Comparator

Participants will receive 4 doses of dexamethasone 6mg IM 48h before elective CS.

干预措施: Dexamethasone phosphate (Drug)

结局指标

主要结局

incidence of neonatal respiratory distress syndrome (RDS)

时间窗: 1st 6 hours after delivery

次要结局

  • APGAR score(5 min after delivery)
  • Rate of Neonatal intraventricular hemorrhage (IVH)(within 1st 48 hours after delivery)

研究者

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

Ahmed Abass

Lecturer

Ain Shams University

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