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IRCT20240630062285N1 IRCT 2024-07-05 Tehran University of Medical Sciences Effect of early oral feeding on consequences of Cesarean section Investigating the effect of early oral feeding on consequences and complications of elective Cesarean section 2024-07-01 anticipated 120 Complete https://irct.ir/trial/77686 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A post operative ileus. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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 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: The data will be made available to researchers and decision-makers in the healthcare system. Conditions: 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. Where to obtain: Contact the corresponding author How to obtain: The process of accessing the data is through correspondence by email or telephone contact with the corresponding author. Comments:
public Arian Faramarzinia
Baharloo hospital, Behdari street, Rahahan square
Tehran Iran (Islamic Republic of) 1594654813 +98 21 5565 8500 Arianfaramarzinia79@gmail.com Tehran University of Medical Sciences scientific Arian Faramarzinia
Baharloo Hospital., Behdari Street., Rahahan Square
Tehran Iran (Islamic Republic of) 1594654813 +98 21 5565 8500 ŮŽArianfaramarzinia79@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Pregnant women at or beyond 37 weeks of gestation who are candidates for elective cesarean section under spinal anesthesia no limit no limit Female 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 K56.7 Ileus, unspecified Treatment - Other Treatment - Other 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. 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. Time to pass flatus post cesarean. Timepoint: Every 6 hours until the patient experiences first flatus passage. Method of measurement: Patient self-report and documentation in the medical record. 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. Maternal satisfaction with hospital stay. Timepoint: At the end of hospitalization. Method of measurement: Visual Analogue Scale. Abdominal cramp. Timepoint: Every 6 hours throughout the hospital stay. Method of measurement: Patient self-report and physician examination using a checklist. Tehran University of Medical Sciences Approved 2023-02-07 Ethics committee of Tehran University of Medical Sciences Baharloo hospital, Behdari street., Rahahan square. Tehran Tehran Iran (Islamic Republic of)