Early Initiation of Oral Feeding Versus Traditional Feeding Post Caesarean Section

Not Applicable

Completed

• Conditions: Complication; Postoperative
• Interventions: Other: Early feeding post caesarean section

• Registration Number: NCT06539117
• Lead Sponsor: Darlington-Peter Chibuzor Ugoji

Brief Summary

Early initiation of oral feeding, within 6-12 hours post-caesarean section, has been noticed to be well tolerated by patients and helps them recover fast. Our study aimed to evaluate the tolerability, safety and benefits of early oral feeding post-caesarean section.

Detailed Description

BACKGROUND: Early initiation of oral feeding, within 6-12 hours post-caesarean section, has been noticed to be well tolerated by patients and helps them recover fast. However, the traditional method of waiting for 24 hours to commence oral feeding post-caesarean section is still being widely practiced due to the fear of post-operative ileus. Though some studies have shown this fear to be unfounded, early initiation of oral feeding is not yet universally accepted.

OBJECTIVES: To evaluate the tolerability, safety and benefits of early oral feeding post-caesarean section.

STUDY DESIGN AND SETTING: This was a randomized control trial (equivalence) carried out at Alex Ekwueme Federal University Teaching Hospital Abakaliki, Nigeria.

METHODS: Three hundred and six eligible women, randomized into groups (A=early and B=traditional feeding group) were admitted into the post natal ward after elective or emergency caesarean section. Women in group A were commenced on graded oral sips 6 hours post- caesarean section and subsequently soft diets from the 12th hour, after oral sips were well tolerated, while those in group B were commenced on the same regimen as in group A 24 hours post-caesarean section.

MAIN OUTCOME MEASURE: Time of return of bowel sound, time of resuming normal diets, duration of hospital stay, and post-operative complications ANALYSIS: Data obtained were analyzed using the computer software, IBM SPSS version 26. Frequency tables were made and results tested for significance using the t-test for continuous variables and Chi-square test for categorical variables. Relative risk (RR) was also determined, with confidence interval set at 95% and the level of significance determined by p-value \< 0.05

Study Timeline

• Study Start: 2023-04-15
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Study First Submitted: 2024-04-14
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-02
• Last Update Submitted: 2024-08-02
• Study First Posted: 2024-08-06
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 153

Inclusion Criteria

• Pregnant women included in this study were those booked for elective or emergency caesarean section under spinal anaesthesia, for various indications from antenatal clinic, antenatal ward, labour ward and obstetric emergency unit who met inclusion criteria and consented to the study.

Exclusion Criteria

• Women with prolonged obstructed labour.
• Women with immunosuppression or HIV/AIDS
• Women with eclampsia.
• Women with medical complications of pregnancy such as:
• Sickle cell anaemia, uncontrolled diabetes, uncontrolled hypertension.
• Women who received general anaesthesia
• Women with previous history of bowel surgery
• Women on drugs that can cause constipation
• Women with previous history of chronic constipation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EARLY FEEDING GROUP	Early feeding post caesarean section	In this group, participants were encouraged to commence oral sips of 150 millilitres of water from 6 hours post-caesarean delivery by the staff nurse. Thereafter, they were given semi-solid diet (250 milliliter of pap) from the 12th hour, and subsequently solid diet (a plate of well- cooked rice) by the trained nursing staff.
TRADITIONAL FEEDING GROUP	Early feeding post caesarean section	Participants in this group were managed traditionally by restricting commencement of oral fluid intake until after 24 hours. They were allowed intake of oral sips of 150 millilitres of water after 24 hours post-caesarean section, thereafter, 250 millilitres of pap and subsequently solid diet (a plate of well-cooked rice)

Primary Outcome Measures

Name	Time	Method
Rate of tolerability of oral sips	48hours	This was the rate of tolerability of oral sips especially in the first 48 hours post surgery as shown by absence of complications such as nausea, vomiting, abdominal distention and paralytic ileus.

Trial Locations

Locations (1)

AEFUTHA; 🇳🇬 Abakaliki, Ebonyi, Nigeria