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临床试验/NCT03396107
NCT03396107已完成3 期

Role of Antenatal Corticosteroid Use in Elective Term Cesarean Section

Assiut University1 个研究点 分布在 1 个国家目标入组 498 人开始时间: 2018年5月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
498
试验地点
1
主要终点
Incidence of respiratory complications after cesarean section

研究概览

简要总结

Caesarean section is a risk factor for the development of neonatal respiratory complications, mostly respiratory distress syndrome (RDS) and transient tachypnoea of the new-born, both in term and preterm infants.

详细描述

Infants born at term by caesarean delivery are more likely to develop respiratory morbidity than infants born vaginally, and this risk increases furthermore for the subgroup of children born by elective caesarean section, i.e. before onset of labour, with potentially severe implications. The risk is decreasing with advancing gestational age, and infants born between 37+0 and 37+6 weeks are at 1.7 times more risk for respiratory complications than those born between 38+0 and 38+6 weeks, which in turn are at 2.4 times more risk than the infants born between 39+0 and 39+6 weeks. If women were given two intramuscular injections of 12 mg of dexamethasone, two doses for 48 hrs,the rates of admissions were 5.2% at 37 weeks, 2.8% at 38 weeks, and 0.6% at 39 weeks. Although none of the babies in the control group died, admission will increase parental anxiety, the cost to nursery unit and invasive procedures including artificial ventilation giving mothers dexamethasone, two doses before elective section halved neonatal morbidity. Five studies lasting between three and 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 In view of this evidence, it is currently recommended that elective caesarean section should be deferred to 39 weeks. However approximately 10%-15% of woman planed for c/s may deliver before 38 weeks, and there may be concern on waiting in the presence of speci c indications or previous history. Respiratory morbidity in cases of term elective caesarean birth appears to have a different pathophysiology than in preterm birth, and retention in the lungs being the most likely cause.

Interestingly, recent evidence indicates that apart from the traditional mechanical concept of vaginal squeeze, molecular mechanisms (predominantly lung epithelial sodium channels promote alveolar uid drainage, and these channels are under active in fetuses unexposed to the process of labor. Glucocorticoid appears to increase the number and the function of thyroid hormones, providing a rational for their exogenous administration in cases of elective caesarean delivery.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Maternal age (18-35 years)
  • Singleton pregnancy
  • Gestational age (38-40 years)

排除标准

  • Major maternal morbidities as DM and pre-eclampsia
  • Sever oligohydramnios
  • Premature rupture of membranes
  • Women who receive steroids during pregnancy

研究组 & 干预措施

Dexamethasone

Active Comparator

Dexamethasone 6mg, IM, 48 hours before cesarean section

干预措施: Dexamethasone (Drug)

Placebo

Placebo Comparator

Placebo 6mg, IM, 48 hours before cesarean section

干预措施: Placebo (Drug)

结局指标

主要结局

Incidence of respiratory complications after cesarean section

时间窗: 30 min

To determine respiratory distress in infants born by elective cesarean section

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

Mohammed Mostafa Haroun

Principle investigator

Assiut University

研究点 (1)

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