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临床试验/NCT06316024
NCT06316024Unknown不适用

Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function During Postpartum Recovery After Cesarean Delivery: A Randomized Controlled Trial

Chiayi Christian Hospital0 个研究点目标入组 200 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

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

No Intervention

The participants do not drink anything approximately 6-8 hours after surgery.

juice/sport drink group

Experimental

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

Experimental

The participants start chewing gum approximately 6-8 hours after surgery.

干预措施: Chewing gum group (Dietary Supplement)

water group

Experimental

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.)

研究者

发起方
Chiayi Christian Hospital
申办方类型
Other
责任方
Sponsor

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