Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cesarean Section
• Intervention / Treatment: Dietary supplement: water; Dietary supplement: juice/sport drink group; Dietary supplement: Chewing gum group

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chia-Hai Liu, Phd; Phone Number: 5579 05-2765041; Email: 02217@cych.org.tw
• Study Contact Backup: Name: Chia-Lung Shih, Phd; Phone Number: 5579 052765041; Email: stone770116@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Nothing Per Os group; The participants do not drink anything approximately 6-8 hours after surgery.
Experimental: water group; The participants drink 240 ml water approximately 6-8 hours after surgery.	Dietary supplement: water; The participants drink 240 mL of water approximately 6-8 hours after surgery
Experimental: juice/sport drink group; The participants drink 240 ml juice/sport drink approximately 6-8 hours after surgery.	Dietary supplement: juice/sport drink group; The participants drink 240 mL of juice/sport drink approximately 6-8 hours after surgery
Experimental: chewing gum group; The participants start chewing gum approximately 6-8 hours after surgery.	Dietary supplement: Chewing gum group; The participants eat chewing gum approximately 6-8 hours after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chiayi Christian Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB2023056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No