Clinical trial NCT06539117: Early Initiation of Oral Feeding Versus Traditional Feeding Post Caesarean Section
Official title: Early Initiation of Oral Feeding Versus Traditional Feeding Post Caesarean Section: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complication
Postoperative
Keywords: Caesarean section
Post-operative feeding
Paralytic ileus
Lead sponsor: Alex Ekwueme Federal University Teaching Hospital
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 153
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open labeled equivalence randomized control trial
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of tolerability of oral sips
timeFrame: 48hours
Secondary outcomes:
Other outcomes:
Locations:
city: Abakaliki
country: Nigeria
facility: AEFUTHA
state: Ebonyi
Study officials:
affiliation: Alex Ekwueme Federal University Teaching Hospital
name: DARLINTON-PETER CHIBUZOR C UGOJI, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.