Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section
试验速览
- 阶段
- 3 期
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- incidence of neonatal respiratory morbidity (NRM)
研究概览
简要总结
Neonatal respiratory morbidities represent a common group of post natal complications including respiratory distress syndrome, transient tachypnea of newborn, and persistent pulmonary hypertension of newborn.
It is thought that preoperative vaginal misoprostol administration may decrease the incidence of neonatal respiratory morbidity especially transient tachypnea of newborn. And therefore, it may decrease the incidence of admission to neonatal intensive care units for respiratory causes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18 years or more.
- •Early term singleton pregnancy.
- •Elective caesarian section at (37 - 38+6) weeks of gestation.
- •Any indication for lower uterine segment caesarian section other than labor (as malpresentations, severe preeclampsia, placenta previa with no previous bleeding attacks, Diabetes Mellitus, macrosomic fetus, non reassuring cardiotocogram (CTG), and fetal growth restriction).
- •Informed written consent signed by the participating pregnant woman.
排除标准
- •Women having any contraindication to Prostaglandin E1 as hypersensitivity, respiratory disease (especially bronchial asthma), or glaucoma.
- •Any mental problems that block understanding of the nature and all the possible consequences of the procedure and the study.
- •Pregnancies of known fetal diseases or chromosomal abnormalities.
- •Non-singleton pregnancies.
- •Emergency caesarian section as in ruptured membrane and women in labor pain.
研究组 & 干预措施
Misoprostol Group
干预措施: Misoprostol (Drug)
Placebo Group
干预措施: Placebo (Drug)
结局指标
主要结局
incidence of neonatal respiratory morbidity (NRM)
时间窗: up to 24 hours after birth
The incidence of neonatal respiratory morbidity, especially transient tachypnea of newborn, in early term neonates born to elective caesarian section.
次要结局
- Neonatal intensive care unit (NICU) admission(up to 24 hours after birth)
研究者
Samar Ali
Principal Investigator
Ain Shams University