A Randomized controlled trial to evaluate the effect of postoperative caffeine intake on the return of bowel movements post caesarean section
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- To assess the timing of passage of first flatus
研究概览
简要总结
An effort to improve post operative recovery with respect to bowel movements has been studied in various clinical studies including prokinetic medications, Chinese medications, chewing gums and acupuncture. Coffee is one of the most common and cheapest beverages taken worldwide including India, in a few studies (reported outside India) it has been shown to improve the recovery of bowel function. Through the present study, we plan to evaluate the effectiveness of postoperative caffeine intake on the return of bowel function post uncomplicated Caesarean Section. If found effective, it may be potentially used as an alternative as a non-pharmacological agent.This will be the first study from Indian settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Undergoing a planned caesarean section at AIIMS Bibinagar under regional anaesthesia;
- •Singleton pregnancy
- •Gestational age more than 37 weeks
- •Body mass index less than and equal to 40
- •Surgery duration less than 90 minutes
- •Patients willing to participate.
排除标准
- •Known Gastrointestinal disorders including history of Chronic Constipation
- •Caffeine allergy
- •Prolonged estimated surgery time (More than 90 mins)
- •Patients refusing to give consent to participate in the study
- •Patients undergoing emergency caesarean section
- •Patients undergoing LSCS under general anesthesia
- •Patients undergoing LSCS under regional but converted to General anesthesia
- •Patients with any obstetric or medical high-risk factor related to pregnancy like Gestational diabetes, Pregnancy induced hypertension, including other known cerebrovascular and cardiovascular co-morbidities;
- •Those not able to tolerate oral intake or caffeine intake(intense epigastric pain, vomiting).
结局指标
主要结局
To assess the timing of passage of first flatus
时间窗: hourly within first 24 hours
次要结局
- To assess the timing of the first bowel movement (bowel sounds) heard in both the groups(To assess the timing of defaecation in both the groups;)
研究者
Anusha Devalla
All India Institute of Medical Sciences, Bibinagar