Clinical trial NCT06316024: Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function
Official title: Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function During Postpartum Recovery After Cesarean Delivery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cesarean Section
Lead sponsor: Chiayi Christian Hospital
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: first time to bowel sound
timeFrame: To record the time duration from immediately after surgery to first bowel sound, an average of 24 hours.
measure: beginning of breastmilk lactation
timeFrame: To record the time duration from immediately after surgery to the beginning of breast milk lactation, an average of 24 hours.
measure: length of hospital stay
timeFrame: To record the length of hospital stay immediately after surgery, and an average of 24 hours.
Secondary outcomes:
measure: time to first drink
timeFrame: To record the time duration from immediately after surgery to the first drink, an average of 24h.
measure: time to first solid food intake
timeFrame: The time duration from immediately after surgery to the first intake of solid food, an average of 24 hours.
measure: duration of IV hydration
timeFrame: The time duration from immediately after surgery to IV hydration, an average of 24h.
measure: IV cannulae removal
timeFrame: To record the time duration from immediately after surgery to IV cannulae removal, an average of 24 h.
measure: first ambulation
timeFrame: To record the time duration from immediately after surgery to first ambulation, an average of 24 hours.
measure: first stool
timeFrame: To record the time period from immediately after surgery to fist stool, an average of 24 hours.
measure: satisfaction VAS (0-100) regarding the early intake
timeFrame: After the finish of the experiment, an average of 5 days.
Other outcomes:
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