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Not yet recruitingNCT06316024Updated Mar 18, 2024

Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function

An interventional study of water and juice/sport drink group in Cesarean Section, sponsored by Chiayi Christian Hospital. Not yet recruiting. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-18.

Sponsored by Chiayi Christian Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Cesarean Section
03

In context

Lead sponsor

Chiayi Christian Hospital is the lead sponsor of 27 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. age between 20 to 65 years
  2. Receiving caesarean delivery
  3. Receiving spinal and/or epidural anesthesia

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • 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

  • 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

  • Experimental
    chewing gum group

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

    Dietary Supplement: Chewing gum group

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

06

What researchers measure

Primary outcomes

  1. first time to bowel sound

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

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

  2. beginning of breastmilk lactation

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

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

  3. length of hospital stay

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

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

Secondary outcomes

  1. time to first drink

    The investigator records the time duration of the first drink

    Time frame: To record the time duration from immediately after surgery to the first drink, an average of 24h.

  2. time to first solid food intake

    The investigator measures the time it takes for the first intake of solid food.

    Time frame: The time duration from immediately after surgery to the first intake of solid food, an average of 24 hours.

  3. duration of IV hydration

    The investigator records the time duration of IV hydration.

    Time frame: The time duration from immediately after surgery to IV hydration, an average of 24h.

  4. IV cannulae removal

    The investigator records the time period of IV cannulae removal.

    Time frame: To record the time duration from immediately after surgery to IV cannulae removal, an average of 24 h.

  5. first ambulation

    The investigator records the time period of first ambulation.

    Time frame: To record the time duration from immediately after surgery to first ambulation, an average of 24 hours.

  6. first stool

    The investigator records the time period of first stool.

    Time frame: To record the time period from immediately after surgery to fist stool, an average of 24 hours.

  7. satisfaction VAS (0-100) regarding the early intake

    The participants report the satisfaction score (range from 0 to 100) for the early intake.

    Time frame: After the finish of the experiment, an average of 5 days.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2024; primary completion for Mar 2025, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2024
First posted
Mar 18, 2024
StartEst.
Mar 2024
Primary completionEst.
Mar 2025
CompletionEst.
Mar 2025
Last update
Mar 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06316024
Lead sponsor
Chiayi Christian Hospital
Responsible party
Sponsor
First posted
Mar 18, 2024
Start date
Mar 2024 (estimated)
Primary completion
Mar 2025 (estimated)
Completion
Mar 2025 (estimated)
Last update
Mar 18, 2024

Study contacts

Chia-Hai Liu, Phd
Contact
02217@cych.org.tw
05-2765041 ext. 5579
Chia-Lung Shih, Phd
Contact
stone770116@gmail.com
052765041 ext. 5579

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Water · Chewing Gum

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