Early Initiation of Oral Feeding Versus Traditional Feeding Post Caesarean Section

Early Initiation of Oral Feeding Versus Traditional Feeding Post Caesarean Section: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Complication; Postoperative
• Intervention / Treatment: Other: Early 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 Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Ebonyi
    • Abakaliki, Ebonyi, Nigeria, 480101
      • AEFUTHA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EARLY FEEDING GROUP; 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.	Other: 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.
Active Comparator: TRADITIONAL FEEDING GROUP; 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)	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of tolerability of oral sips	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.	48hours

Collaborators and Investigators

• Sponsor: Darlington-Peter Chibuzor Ugoji
• Investigators: Principal Investigator: DARLINTON-PETER CHIBUZOR C UGOJI, MBBS, Alex Ekwueme Federal University Teaching Hospital

Publications and helpful links

General Publications

• Mamah J.E, Asiegbu O, Asiegbu U, Nnadozie U, Okafor L. A six-year review of caesarean section at the Federal Teaching Hospital Abakaliki, Ebonyi State, South East Nigeria. Open Journal of Obstetrics and Gynaecology, 2020 Dec,11; (10) 1669-1676.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: April 14, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Caesarean section; Paralytic ileus; Post-operative feeding
• Other Study ID Numbers: NHREC/16/05/22/185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This will be following publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No