Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function During Postpartum Recovery After Cesarean Delivery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- first time to bowel sound
研究概览
简要总结
The percentage of cesarean deliveries is on the rise, accounting for 30-40% of all deliveries in Taiwan. Following a cesarean delivery, a few doctors in Taiwan still adheres to the progressive eating regimen of "nothing per mouth" for 24 hours or until the patient passes flatus or hears bowel sounds. However, a meta-analysis has shown that early oral intake (6-8 hours) significantly reduces the time required for the restoration of gastrointestinal function and hospital stay compared to delayed oral intake. Furthermore, early oral intake has not shown to increase the likelihood of gastrointestinal complications. While several food types have been adopted for early oral intake, no study has investigated the effect of different food types on clinical outcomes regarding gastrointestinal function and hospital stay for cesarean delivery. Therefore, the objective of this study is to investigate the effect of different food types on clinical outcomes for cesarean delivery through a randomized controlled trial. The subjects of this study are pregnant women who come to Chiayi Christian Hospital to schedule cesarean deliveries. They are randomly assigned to one of four groups: nothing by mouth, water, juice/sports drink, or chewing gum. The relevant clinical outcomes, such as time to first bowel sound or readiness for discharge, are recorded. One-way analysis of variance or Chi-square test is used to compare the differences among the four groups. Our expected results could provide valuable information on the type of food that could be used to improve the recovery of mothers after cesarean delivery and increase the quality of breastfeeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age between 20 to 65 years
- •Receiving caesarean delivery
- •Receiving spinal and/or epidural anesthesia
排除标准
- •Clinical diagnosis of pre-existing gastrointestinal disorders
- •.Clinical diagnosis of an intraoperative blood loss exceeding 1000 ml during cesarean delivery
- •Clinical diagnosis of existing chronic medical disorders
- •.History of major abdominal surgery
- •Clinical diagnosis of any acute complications resulting from cesarean delivery
研究组 & 干预措施
Nothing Per Os group
The participants do not drink anything approximately 6-8 hours after surgery.
juice/sport drink group
The participants drink 240 ml juice/sport drink approximately 6-8 hours after surgery.
干预措施: juice/sport drink group (Dietary Supplement)
chewing gum group
The participants start chewing gum approximately 6-8 hours after surgery.
干预措施: Chewing gum group (Dietary Supplement)
water group
The participants drink 240 ml water approximately 6-8 hours after surgery.
干预措施: water (Dietary Supplement)
结局指标
主要结局
first time to bowel sound
时间窗: To record the time duration from immediately after surgery to first bowel sound, an average of 24 hours.
The investigator records the time duration of the first occurrence of bowel sounds immediately after surgery
beginning of breastmilk lactation
时间窗: To record the time duration from immediately after surgery to the beginning of breast milk lactation, an average of 24 hours.
The investigator records the time of the beginning of breast milk lactation.
length of hospital stay
时间窗: To record the length of hospital stay immediately after surgery, and an average of 24 hours.
The investigator records the length of hospital stay for each participant.
次要结局
- time to first drink(To record the time duration from immediately after surgery to the first drink, an average of 24h.)
- time to first solid food intake(The time duration from immediately after surgery to the first intake of solid food, an average of 24 hours.)
- duration of IV hydration(The time duration from immediately after surgery to IV hydration, an average of 24h.)
- satisfaction VAS (0-100) regarding the early intake(After the finish of the experiment, an average of 5 days.)
- IV cannulae removal(To record the time duration from immediately after surgery to IV cannulae removal, an average of 24 h.)
- first ambulation(To record the time duration from immediately after surgery to first ambulation, an average of 24 hours.)
- first stool(To record the time period from immediately after surgery to fist stool, an average of 24 hours.)
