NCT06539117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

April 14, 2024

Last Update Submit

August 2, 2024

Conditions

Keywords

Caesarean sectionPost-operative feedingParalytic ileus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

EARLY FEEDING GROUP

EXPERIMENTAL

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

TRADITIONAL FEEDING GROUP

ACTIVE COMPARATOR

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

Interventions

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.

EARLY FEEDING GROUPTRADITIONAL FEEDING GROUP

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPost Caesarean section
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AEFUTHA

Abakaliki, Ebonyi State, 480101, Nigeria

Location

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

Intestinal Pseudo-Obstruction

Condition Hierarchy (Ancestors)

IleusIntestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • DARLINTON-PETER CHIBUZOR C UGOJI, MBBS

    Alex Ekwueme Federal University Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Open labeled equivalence randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2024

First Posted

August 6, 2024

Study Start

April 15, 2023

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

This will be following publication

Locations