Effectiveness of Mouth Dissolving Mosapride Tablets on Enhancing Gut Recovery After Cesarean Section: Randomized Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Time of first flatus
研究概览
简要总结
Giving women one day before and immediately after cesarean section a mouthly dissolving mosapride tablets 2every every 8 hours for maximum of 5 days ,or getting recovered gastrointestinal functions And assess preoperative gastrointestinal functions
详细描述
Uncomplicated post cesarean women one day before and immediately after elective cesarean receive 2 mouthly dissolving mosapride tablets every 8 hours maximum for 5 days and clinical care giver follow the woman's gastrointestinal functions, including intraoperative and postoperative nausea vomiting, passing flatus, hearing intestinal sounds, passing stools, occurring of paralytic ileus, length of the hospital stay
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, Outcomes Assessor)
盲法说明
Color coded active tablets backed in red while identical dummy tablets coded in blue,both tablets are physically identical and usually no anticipated noticed side effects from mosapride
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •all women undergoing elective cesarean section
排除标准
- •prior abdominal surgery, abdominal adhesion, chronic constipation, allergy to mosapride
研究组 & 干预措施
Mouth dissolving mosapride
Fluxopride 5mg of Macryrl egypt 2 tablets one day before and immediately after elective cesarean section every 8hour for maximum of 5 days
干预措施: Mosapride (Drug)
Placebo mouth dissolving tablets
Dummy identical tablets taken in the same way
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Time of first flatus
时间窗: 96 hours postoperative
Clinical
次要结局
- Paralytic ileus incidence and its severity(7days)
- Toleration of fluids and solids intake(2 weeks postoperative)
- Incidence of intraoperative and postoperative nausea and vomiting(Intraoperative and 2 weeks postoperative)
- First defecation(2 weeks postoperative)
研究者
ashraf nassif mahmoud elmantwe,MD
Assistant professor
Benha University