Misoprostol Administration Before Elective Caesarean Section to Reduce the Risk of Respiratory Morbidity in Newborns
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- the incidence of Transient tachypnea of the newborn which defined by increase respiratory rate more than 60 cycle per minute in pregnant women with gestational age less than 38 weeks before elective cesarean section
研究概览
简要总结
The aim of our study is to evaluate the efficacy of Misoprostol before elective cesarean section in pregnant women with gestational age less than 38 weeks for preventing the occurrence of neonatal respiratory morbidity.
详细描述
Caesarean section is one of the most common carried out surgical procedures in modern obstetrics. About 18.5 million caesarean section are conducted yearly worldwide, and 21-33% of all caesarean section are performed in middle and high-income countries.
The most frequent complications that are seen in neonates include respiratory morbidity, hypoglycemia, sepsis, and admission to the neonatal intensive care unit (NICU). The family and caregivers are affected in many ways when a newborn is admitted to the intensive care unit.
Both preterm and term infants delivered by caesarean section have been reported to experience respiratory distress syndrome, which is brought on by a surfactant deficiency.
Respiratory distress (RD) affects about 27% of babies born, and it is more common in newborns delivered by elective cesarean section (ECS) than in emergency CS or vaginally.
In the neonatal intensive care unit, neonatal respiratory distress syndrome (NRDS), which is mostly brought on by pulmonary surfactant insufficiency after delivery, is acknowledged as one of the most frequent causes of respiratory distress in newborn preterm infants.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with indication for elective caesarean section.
- •Age less than 35 years old.
- •Gestational age less than 38 weeks.
- •Gestational age will be confirmed by certain LMP or reliable early ultrasound measurement of crown-rump length.
- •Singleton pregnancy with no major anomalies
排除标准
- •Any obstetric disorders as preeclampsia and diabetes.
- •Fetus with oligohydramnios, intrauterine growth restriction.
- •Any contraindications to misoprostol like those with previous allergic reaction or hypersensitivity to prostaglandin hemorrhagic disorders, and severe anemia.
- •History of more than or equal 2 previous caesarean section.
研究组 & 干预措施
Misoprostol before elective cesarean section .
candidates will receive 100mcg Misoprostol one hour before elective caesarean section.
干预措施: Misoprostol (Drug)
Giving no treatment before elective caesarean section.
candidates will receive no treatment before elective caesarean section.
干预措施: Misoprostol (Drug)
结局指标
主要结局
the incidence of Transient tachypnea of the newborn which defined by increase respiratory rate more than 60 cycle per minute in pregnant women with gestational age less than 38 weeks before elective cesarean section
时间窗: in the first 5 minute after delivery of fetus post operative
次要结局
未报告次要终点
研究者
Merna Ashraf Ahmed Farid
gynaecologist and obsteterician resident
Kafrelsheikh University