Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06316024
• Other study ID #: IRB2023056
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Chiayi Christian Hospital
• Contact: Chia-Hai Liu, Phd
• Phone: 05-2765041
• Email: 02217[@]cych.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Dietary Supplement:
• water
The participants drink 240 mL of water approximately 6-8 hours after surgery
• juice/sport drink group
The participants drink 240 mL of juice/sport drink approximately 6-8 hours after surgery
• Chewing gum group
The participants eat chewing gum approximately 6-8 hours after surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chiayi Christian Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.