Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function

Not Applicable

Not yet recruiting

• Conditions: Cesarean Section
• Interventions: Dietary Supplement: Chewing gum group; Dietary Supplement: water; Dietary Supplement: juice/sport drink group

• Registration Number: NCT06316024
• Lead Sponsor: Chiayi Christian Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-04
• Status Verified: 2024-02
• Study Start: 2024-03
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-18
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. age between 20 to 65 years
2. Receiving caesarean delivery
3. Receiving spinal and/or epidural anesthesia

Exclusion Criteria

1. Clinical diagnosis of pre-existing gastrointestinal disorders
2. .Clinical diagnosis of an intraoperative blood loss exceeding 1000 ml during cesarean delivery
3. Clinical diagnosis of existing chronic medical disorders
4. .History of major abdominal surgery
5. Clinical diagnosis of any acute complications resulting from cesarean delivery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chewing gum group	Chewing gum group	The participants start chewing gum approximately 6-8 hours after surgery.
water group	water	The participants drink 240 ml water approximately 6-8 hours after surgery.
juice/sport drink group	juice/sport drink group	The participants drink 240 ml juice/sport drink approximately 6-8 hours after surgery.

Primary Outcome Measures

Name	Time	Method
first time to bowel sound	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	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	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.

Secondary Outcome Measures

Name	Time	Method
time to first drink	To record the time duration from immediately after surgery to the first drink, an average of 24h.	The investigator records the time duration of the first drink
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.	The investigator measures the time it takes for the first intake of solid food.
duration of IV hydration	The time duration from immediately after surgery to IV hydration, an average of 24h.	The investigator records the time duration of IV hydration.
satisfaction VAS (0-100) regarding the early intake	After the finish of the experiment, an average of 5 days.	The participants report the satisfaction score (range from 0 to 100) for the early intake.
IV cannulae removal	To record the time duration from immediately after surgery to IV cannulae removal, an average of 24 h.	The investigator records the time period of IV cannulae removal.
first ambulation	To record the time duration from immediately after surgery to first ambulation, an average of 24 hours.	The investigator records the time period of first ambulation.
first stool	To record the time period from immediately after surgery to fist stool, an average of 24 hours.	The investigator records the time period of first stool.