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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06316024
Enrollment
200
Registered
2024-03-18
Start date
2024-03-31
Completion date
2025-03-31
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

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.

Interventions

DIETARY_SUPPLEMENTwater

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

DIETARY_SUPPLEMENTjuice/sport drink group

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

DIETARY_SUPPLEMENTChewing gum group

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

Sponsors

Chiayi Christian Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
first time to bowel soundTo record the time duration from immediately after surgery to first bowel sound, an average of 24 hours.The investigator records the time duration of the first occurrence of bowel sounds immediately after surgery
beginning of breastmilk lactationTo record the time duration from immediately after surgery to the beginning of breast milk lactation, an average of 24 hours.The investigator records the time of the beginning of breast milk lactation.
length of hospital stayTo record the length of hospital stay immediately after surgery, and an average of 24 hours.The investigator records the length of hospital stay for each participant.

Secondary

MeasureTime frameDescription
time to first solid food intakeThe time duration from immediately after surgery to the first intake of solid food, an average of 24 hours.The investigator measures the time it takes for the first intake of solid food.
duration of IV hydrationThe time duration from immediately after surgery to IV hydration, an average of 24h.The investigator records the time duration of IV hydration.
first stoolTo record the time period from immediately after surgery to fist stool, an average of 24 hours.The investigator records the time period of first stool.
first ambulationTo record the time duration from immediately after surgery to first ambulation, an average of 24 hours.The investigator records the time period of first ambulation.
IV cannulae removalTo record the time duration from immediately after surgery to IV cannulae removal, an average of 24 h.The investigator records the time period of IV cannulae removal.
satisfaction VAS (0-100) regarding the early intakeAfter the finish of the experiment, an average of 5 days.The participants report the satisfaction score (range from 0 to 100) for the early intake.
time to first drinkTo record the time duration from immediately after surgery to the first drink, an average of 24h.The investigator records the time duration of the first drink

Contacts

Primary ContactChia-Hai Liu, Phd
02217@cych.org.tw05-2765041
Backup ContactChia-Lung Shih, Phd
stone770116@gmail.com052765041

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026