Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function

Chiayi Christian Hospital

Status: Not yet enrolling

Conditions: Cesarean Section

Treatments: Dietary Supplement: Chewing gum group; Dietary Supplement: water; Dietary Supplement: juice/sport drink group

Study type: Interventional

Funder types: Other

Identifiers

NCT06316024

IRB2023056

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Nothing Per Os group

No Intervention group

Description:

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

water group

Experimental group

Description:

The participants drink 240 ml water approximately 6-8 hours after surgery.

Treatment:

Dietary Supplement: water

juice/sport drink group

Experimental group

Description:

The participants drink 240 ml juice/sport drink approximately 6-8 hours after surgery.

Treatment:

Dietary Supplement: juice/sport drink group

chewing gum group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Chewing gum group