To determine the effect of early initiation of oral feeding on the time to first bowel movement in the population of patients undergoing elective cesarean section.
To determine the effect of early initiation of oral feeding on the time to first flatus passage in the population of patients undergoing elective cesarean section.
To determine the effect of early initiation of oral feeding on gastrointestinal complications in the population of patients undergoing elective cesarean section.
Design
This was a phase 2, randomized, parallel-group, single-blind, controlled clinical trial conducted on 120 patients.
Randomization was performed using the rand function in Excel software.
Settings and conduct
All patients undergo elective cesarean section in the morning. Initiation of feeding at the specified time points:
In the first group, 4 hours after surgery, patients receive warm tea followed by hospital diet.
In the second group, 8 hours after surgery, patients receive warm tea followed by hospital diet.
Patients are provided with a questionnaire to record the time of first flatus passage and bowel movement.
Nurses assess and record gastrointestinal symptoms such as nausea, vomiting, and anorexia using a checklist.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Pregnant women at or beyond 37 weeks of gestation who are candidates for elective cesarean section under spinal anesthesia.
Exclusion Criteria:
Women who experienced postoperative hemorrhage or any other complication.
Intervention groups
1-Patients who experience early oral feeding 4 hours after cesarean delivery (Intervention group)
2-Patients who receive oral feeding 8 hours after cesarean delivery (Control group)
Main outcome variables
To determine the effect of early initiation of oral feeding on postoperative outcomes and complications in patients undergoing elective cesarean section.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240630062285N1
Registration date:2024-07-05, 1403/04/15
Registration timing:registered_while_recruiting
Last update:2024-07-05, 1403/04/15
Update count:0
Registration date
2024-07-05, 1403/04/15
Registrant information
Name
Arian Faramarzinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5565 8500
Email address
ma-dohadi@tums.student.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-01, 1403/04/11
Expected recruitment end date
2024-09-18, 1403/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of early oral feeding on consequences and complications of elective Cesarean section
Public title
Effect of early oral feeding on consequences of Cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women at or beyond 37 weeks of gestation who are candidates for elective cesarean section under spinal anesthesia
Exclusion criteria:
Patients who experienced severe adhesions during their cesarean section Procedure duration was longer than 45 minutes Women with underlying gastrointestinal conditions such as inflammatory bowel disease Patients with emergency delivery indications (e.g., placenta previa, premature rupture of membranes, etc.) Patients who, for any reason, including contraindications to general anesthesia or spinal anesthesia, or personal preference, did not receive spinal anesthesia during their cesarean section Women who experienced postoperative hemorrhage
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were randomly assigned to groups using a computer-generated random number sequence with a block size of four. The generated identifiers were placed in sealed envelopes by a statistician and attached to the doctor's order sheets. The envelopes were opened after surgery, and the information was manually recorded onto the clinicians' order sheets. Nurses provided oral feedings to the participants. The analyzer was blinded to the group assignments, but the participants and nurses were not.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants were randomly assigned to groups using a computer-generated random number sequence with a block size of four. The generated identifiers were placed in sealed envelopes by a statistician and attached to the doctor's order sheets. The envelopes were opened after surgery, and the information was manually recorded onto the clinicians' order sheets. Nurses provided oral feedings to the participants. The analyzer was blinded to the group assignments, but the participants and nurses were not. The same person who distributed the informed consent and performed the analysis was the blinded assessor.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Every 6 hours until the patient experiences first flatus passage.
Method of measurement
Patient self-report and documentation in the medical record.
Secondary outcomes
1
Description
Time to first bowel movement after cesarean section
Timepoint
Every 6 hours until the patient experiences first bowel movement
Method of measurement
Patient self-report and documentation in the medical record
2
Description
Maternal satisfaction with hospital stay
Timepoint
At the end of hospitalization
Method of measurement
Visual Analogue Scale
3
Description
abdominal cramp
Timepoint
Every 6 hours throughout the hospital stay.
Method of measurement
Patient self-report and physician examination using a checklist.
Intervention groups
1
Description
Intervention group: Patients who experience early oral feeding 4 hours after cesarean delivery. Patients undergo elective cesarean section in the morning. Initiation of feeding 4 hours after surgery with warm tea followed by hospital diet. Patients are advised to avoid raw fruits, milk, and legumes for 12 hours after the operation.
Category
Treatment - Other
2
Description
Control group: Patients who experience early oral feeding 8 hours after cesarean delivery. Patients undergo elective cesarean section in the morning. Initiation of feeding 8 hours after surgery with warm tea followed by hospital diet. Patients are advised to avoid raw fruits, milk, and legumes for 12 hours after the operation.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After completing the study, the results of the study will be published in the form of a scientific article, and the data will be accessible through correspondence with the corresponding author.
When the data will become available and for how long
The possibility of accessing the data will be available after the publication of the study results in scientific journals, which will be around 9 months after the completion of the study.
To whom data/document is available
The data will be made available to researchers and decision-makers in the healthcare system.
Under which criteria data/document could be used
The data will be made available if the purpose of the research is to improve healthcare for patients, while maintaining the privacy of the participants.
From where data/document is obtainable
Contact the corresponding author
What processes are involved for a request to access data/document
The process of accessing the data is through correspondence by email or telephone contact with the corresponding author.