Cesarean SectionNCT06316024
Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function
A study testing water, juice/sport drink group and Chewing gum group in people with Cesarean Section, run by Chiayi Christian Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- water, juice/sport drink group and Chewing gum group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 20 to 65 years
- Receiving caesarean delivery
- Receiving spinal and/or epidural anesthesia
Who cannot join
- Clinical diagnosis of pre-existing gastrointestinal disorders
- .Clinical diagnosis of an intraoperative blood loss exceeding 1000 ml during cesarean delivery
- Clinical diagnosis of existing chronic medical disorders
- .History of major abdominal surgery
- Clinical diagnosis of any acute complications resulting from cesarean delivery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Cesarean Section
- Being tested
- water, juice/sport drink group, Chewing gum group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
waterDietary supplement
The participants drink 240 mL of water approximately 6-8 hours after surgery
juice/sport drink groupDietary supplement
The participants drink 240 mL of juice/sport drink approximately 6-8 hours after surgery
Chewing gum groupDietary supplement
The participants eat chewing gum approximately 6-8 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| Nothing Per Os group | No intervention | The participants do not drink anything approximately 6-8 hours after surgery. |
| water group | Experimental | The participants drink 240 ml water approximately 6-8 hours after surgery. Receives: Dietary Supplement: water |
| juice/sport drink group | Experimental | The participants drink 240 ml juice/sport drink approximately 6-8 hours after surgery. Receives: Dietary Supplement: juice/sport drink group |
| chewing gum group | Experimental | The participants start chewing gum approximately 6-8 hours after surgery. Receives: Dietary Supplement: Chewing gum group |
What is being measured
The primary outcome is the main question the study is designed to answer.
first time to bowel sound
The investigator records the time duration of the first occurrence of bowel sounds immediately after surgery
Measured: 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.
Measured: 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.
Measured: To record the length of hospital stay immediately after surgery, and an average of 24 hours.
Secondary outcomes (7)
time to first drink
The investigator records the time duration of the first drink
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After the finish of the experiment, an average of 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316024
- Sponsor's protocol ID
- IRB2023056
- Status last verified
- Feb 2024
- First submitted
- 4 Jan 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function During Postpartum Recovery After Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06316024
- Acronym / sponsor ID
- IRB2023056
- Conditions
- Cesarean Section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nothing Per Os group | No intervention | –The participants do not drink anything approximately 6-8 hours after surgery. |
| water group | Experimental | Dietary Supplement: waterThe participants drink 240 ml water approximately 6-8 hours after surgery. |
| juice/sport drink group | Experimental | Dietary Supplement: juice/sport drink groupThe participants drink 240 ml juice/sport drink approximately 6-8 hours after surgery. |
| chewing gum group | Experimental | Dietary Supplement: Chewing gum groupThe participants start chewing gum approximately 6-8 hours after surgery. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 20 to 65 years
- Receiving caesarean delivery
- Receiving spinal and/or epidural anesthesia
Key exclusion criteria (5 listed)
- Clinical diagnosis of pre-existing gastrointestinal disorders
- .Clinical diagnosis of an intraoperative blood loss exceeding 1000 ml during cesarean delivery
- Clinical diagnosis of existing chronic medical disorders
- .History of major abdominal surgery
- Clinical diagnosis of any acute complications resulting from cesarean delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| waterThe participants drink 240 mL of water approximately 6-8 hours after surgery | Dietary supplement | water group |
| juice/sport drink groupThe participants drink 240 mL of juice/sport drink approximately 6-8 hours after surgery | Dietary supplement | juice/sport drink group |
| Chewing gum groupThe participants eat chewing gum approximately 6-8 hours after surgery | Dietary supplement | chewing gum group |
Primary outcome
first time to bowel sound
Time frame: To 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 lactation
Time frame: To 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 stay
Time frame: To 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.
7 secondary outcomes
time to first drink
Time frame: To record the time duration from immediately after surgery to the first drink, an average of 24h.
time to first solid food intake
Time frame: The time duration from immediately after surgery to the first intake of solid food, an average of 24 hours.
duration of IV hydration
Time frame: The time duration from immediately after surgery to IV hydration, an average of 24h.
IV cannulae removal
Time frame: To record the time duration from immediately after surgery to IV cannulae removal, an average of 24 h.
first ambulation
Time frame: To record the time duration from immediately after surgery to first ambulation, an average of 24 hours.
first stool
Time frame: 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
Time frame: After the finish of the experiment, an average of 5 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing water, juice/sport drink group and Chewing gum group in people with Cesarean Section, run by Chiayi Christian Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Hai Liu, Phd (05-2765041 ext. 5579, 02217@cych.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first time to bowel sound (time frame: To record the time duration from immediately after surgery to first bowel sound, an average of 24 hours.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.