Effect of Coffee Consumption on Intestinal Motility After Caesarean Sections; Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- passage of stool.
研究概览
简要总结
Randomized controlled trial in Obstetrics and Gynecology department (MULTI-CENTRIC).To measure the effect of coffee consumption on intestinal motility after caesarean section for the patient who fulfills the criteria. Then they will be randomized to 3 groups. The primary outcome and secondary outcome will be measured.
详细描述
Randomized controlled trial. Participants who fulfill the inclusion criteria (elective caesarian section, singleton pregnancy, term, viable fetus), and exclusion criteria (medical disorders, known intestinal diseases, past history of intestinal surgery, intraoperative diagnosis of extensive adhesion, intraoperative complications "e.g., intestinal injury and ureteric injury intraoperative complication that can lengthen the operation time, postoperative complications like anesthesia complication and electrolytes imbalance ) Then they will be randomized to 3 groups. Group 1, will start to drink coffee 6 hours postoperative for maximum 3 doses (100ml), 8 hours apart, diet will start after 1st audible bowel sound.
Group 2, will drink water 6 hours postoperative. Diet will start after 1st audible bowel sound.
Group 3 is the control group and they will be (NOTHING PER ORAL) for 24 hours on intravenous fluid (3 LITRES/24 HOURS). Diet will start after 1st audible bowel sound.
Primary outcome: passage of stool. Secondary outcome: passage of flatus, audible intestinal sound time, feeding time, pain scale by Visual Analogue Scale (VAS), amount, and type of analgesia needed, breastfeeding time, mobilization and 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
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •elective caesarian section, singleton pregnancy, term, viable fetus
排除标准
- •medical disorders, known intestinal diseases, past history of intestinal surgery, intraoperative diagnosis of extensive adhesion, intraoperative complications "e.g., intestinal injury and ureteric injury intraoperative complication that can lengthen the operation time, postoperative complications like anesthesia complication and electrolytes imbalance )
结局指标
主要结局
passage of stool.
时间窗: 72 hours
passage of stool within 72 hours. (time to be recorded by 24-hour clock from finishing of surgery)
次要结局
- Type of analgesia needed.(72 hours)
- The amount of analgesia .(72 hours)
- Audible intestinal sound time.(72 hours)
- Pain scale by VAS (Visual Analogue Scale ).(72 hours)
- The first Breastfeeding time.(72 hours)
- Passage of flatus. . The amount of analgesia. The first Breastfeeding time. The initiation of Mobilization. Hospital length stay.(72 hours)
- Feeding time(72 hours)
- Hospital length stay.(72 hours)
- The initiation of Mobilization.(72 hours)
研究者
Mufareh Asiri
OB/GYN REGISTRAR
Armed Forces Hospitals, Southern Region, Saudi Arabia