Early Initiation of Oral Feeding Versus Traditional Feeding Post Caesarean Section: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Rate of tolerability of oral sips
研究概览
简要总结
Early initiation of oral feeding, within 6-12 hours post-caesarean section, has been noticed to be well tolerated by patients and helps them recover fast. Our study aimed to evaluate the tolerability, safety and benefits of early oral feeding post-caesarean section.
详细描述
BACKGROUND: Early initiation of oral feeding, within 6-12 hours post-caesarean section, has been noticed to be well tolerated by patients and helps them recover fast. However, the traditional method of waiting for 24 hours to commence oral feeding post-caesarean section is still being widely practiced due to the fear of post-operative ileus. Though some studies have shown this fear to be unfounded, early initiation of oral feeding is not yet universally accepted.
OBJECTIVES: To evaluate the tolerability, safety and benefits of early oral feeding post-caesarean section.
STUDY DESIGN AND SETTING: This was a randomized control trial (equivalence) carried out at Alex Ekwueme Federal University Teaching Hospital Abakaliki, Nigeria.
METHODS: Three hundred and six eligible women, randomized into groups (A=early and B=traditional feeding group) were admitted into the post natal ward after elective or emergency caesarean section. Women in group A were commenced on graded oral sips 6 hours post- caesarean section and subsequently soft diets from the 12th hour, after oral sips were well tolerated, while those in group B were commenced on the same regimen as in group A 24 hours post-caesarean section.
MAIN OUTCOME MEASURE: Time of return of bowel sound, time of resuming normal diets, duration of hospital stay, and post-operative complications ANALYSIS: Data obtained were analyzed using the computer software, IBM SPSS version 26. Frequency tables were made and results tested for significance using the t-test for continuous variables and Chi-square test for categorical variables. Relative risk (RR) was also determined, with confidence interval set at 95% and the level of significance determined by p-value < 0.05
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women included in this study were those booked for elective or emergency caesarean section under spinal anaesthesia, for various indications from antenatal clinic, antenatal ward, labour ward and obstetric emergency unit who met inclusion criteria and consented to the study.
排除标准
- •Women with prolonged obstructed labour.
- •Women with immunosuppression or HIV/AIDS
- •Women with eclampsia.
- •Women with medical complications of pregnancy such as:
- •Sickle cell anaemia, uncontrolled diabetes, uncontrolled hypertension.
- •Women who received general anaesthesia
- •Women with previous history of bowel surgery
- •Women on drugs that can cause constipation
- •Women with previous history of chronic constipation
结局指标
主要结局
Rate of tolerability of oral sips
时间窗: 48hours
This was the rate of tolerability of oral sips especially in the first 48 hours post surgery as shown by absence of complications such as nausea, vomiting, abdominal distention and paralytic ileus.
次要结局
未报告次要终点
研究者
Darlington-Peter Chibuzor Ugoji
Principal Investigator
Alex Ekwueme Federal University Teaching Hospital