Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function

NCT ID: NCT06316024

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2025-03-31

Brief Summary

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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

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Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nothing Per Os group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

water group

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

Group Type EXPERIMENTAL

water

Intervention Type DIETARY_SUPPLEMENT

The participants drink 240 mL of water approximately 6-8 hours after surgery

juice/sport drink group

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

Group Type EXPERIMENTAL

juice/sport drink group

Intervention Type DIETARY_SUPPLEMENT

The participants drink 240 mL of juice/sport drink approximately 6-8 hours after surgery

chewing gum group

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

Group Type EXPERIMENTAL

Chewing gum group

Intervention Type DIETARY_SUPPLEMENT

The participants eat chewing gum approximately 6-8 hours after surgery

Interventions

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water

The participants drink 240 mL of water approximately 6-8 hours after surgery

Intervention Type DIETARY_SUPPLEMENT

juice/sport drink group

The participants drink 240 mL of juice/sport drink approximately 6-8 hours after surgery

Intervention Type DIETARY_SUPPLEMENT

Chewing gum group

The participants eat chewing gum approximately 6-8 hours after surgery

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chiayi Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Chia-Hai Liu, Phd

Role: CONTACT

05-2765041 ext. 5579

Chia-Lung Shih, Phd

Role: CONTACT

052765041 ext. 5579

Other Identifiers

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IRB2023056

Identifier Type: -

Identifier Source: org_study_id

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