Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function

NCT06316024 | Not Yet Recruiting

• 1 other identifier: IRB2023056
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (3)

• first time to bowel sound

  The investigator records the time duration of the first occurrence of bowel sounds immediately after surgery

  To record the time duration from immediately after surgery to first bowel sound, an average of 24 hours.

• beginning of breastmilk lactation

  The investigator records the time of the beginning of breast milk lactation.

  To record the time duration from immediately after surgery to the beginning of breast milk lactation, an average of 24 hours.

• length of hospital stay

  The investigator records the length of hospital stay for each participant.

  To record the length of hospital stay immediately after surgery, and an average of 24 hours.

Secondary Outcomes (7)

• 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.

• 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.

Study Arms (4)

Nothing Per Os group

NO INTERVENTION

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

water group

EXPERIMENTAL

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

Dietary Supplement: water

juice/sport drink group

EXPERIMENTAL

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

Dietary Supplement: juice/sport drink group

chewing gum group

EXPERIMENTAL

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

Dietary Supplement: Chewing gum group

Interventions

water DIETARY_SUPPLEMENT

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

water group

juice/sport drink group DIETARY_SUPPLEMENT

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

juice/sport drink group

Chewing gum group DIETARY_SUPPLEMENT

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

chewing gum group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 20 to 65 years
• Receiving caesarean delivery
• Receiving spinal and/or epidural anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiayi Christian Hospital: lead

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Central Study Contacts

Chia-Hai Liu, Phd

CONTACT

05-2765041; 02217@cych.org.tw

Chia-Lung Shih, Phd

CONTACT

052765041; stone770116@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: March 18, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share