Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- The need for admission to neonatal intensive care unit (NICU)
研究概览
简要总结
Neonatal respiratory distress may occur in either term or preterm newborns with a higher relative risk in preterm, and whether born vaginally or through caesarean section, but in a higher percentage after elective caesarean section whose rate is rising.
Prostaglandins may be given about one hour before an elective caesarean section after excluding the presence of contraindication to their use to decrease the neonatal respiratory diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that occurs frequently in children who had previously TTN will diminish.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years or more.
- •Term singleton pregnancy (38 - 38+6 weeks gestation).
- •Planned for elective transverse lower segment caesarean section with an indication.
排除标准
- •Women with history of significant cardiac disease, eclampsia, pre eclampsia, epilepsy, severe asthma, severe allergic condition, vascular disease, renal or hepatic disease.
- •Women with contraindication to prostaglandins as Glucoma or known hypersensitivity to prostaglandins or specifically for misoprostol.
- •Psychological problem or mental disease that renders the patient not able to understand the nature, scope, and sequences of the study.
- •Pregnancies with known foetal malformation/s or chromosomal aberration.
研究组 & 干预措施
Misoprostol
After preparing for elective caesarean section, the pessary will be given containing the misoprostol medication 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized
干预措施: Misoprostol (Drug)
Placebo
After preparing for elective caesarean section, the pessary will be given containing placebo 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized
干预措施: Placebos (Drug)
结局指标
主要结局
The need for admission to neonatal intensive care unit (NICU)
时间窗: first 24 hours after delivery
Number of newborns admitted to NICU for respiratory morbidity
次要结局
- APGAR score below 6 at 5 minute(5 minutes after delivery)
研究者
Ahmed Mohamed El Kotb Abdel Fattah
Dr., Lecturer in obstertics and gynecology, Ain Shams University Hospital
Ain Shams University