ComplicationNCT06539117
Early Initiation of Oral Feeding Versus Traditional Feeding Post Caesarean Section
A study testing Early feeding post caesarean section in people with Complication and Postoperative, run by Darlington-Peter Chibuzor Ugoji at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complication, Postoperative
- What is being tested?
- Early feeding post caesarean section
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteNigeria
- Study dates
- 15 Apr 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Women with previous history of bowel surgery
- Women on drugs that can cause constipation
- Women with previous history of chronic constipation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Complication, Postoperative
- Being tested
- Early feeding post caesarean section
- Keywords
- Caesarean section, Post-operative feeding, Paralytic ileus
- Medical subject headings
- Intestinal Pseudo-Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early feeding post caesarean sectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Other: Early feeding post caesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start15 Apr 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open labeled equivalence randomized control trial
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Darlington-Peter Chibuzor Ugoji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Darlington-Peter Chibuzor Ugoji, Alex Ekwueme Federal University Teaching Hospital
- Investigators
- DARLINTON-PETER CHIBUZOR C UGOJI, MBBS, Principal investigator, Alex Ekwueme Federal University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539117
- Sponsor's protocol ID
- NHREC/16/05/22/185
- Status last verified
- Aug 2024
- First submitted
- 14 Apr 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This will be following publication
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 at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Initiation of Oral Feeding Versus Traditional Feeding Post Caesarean Section: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06539117
- Acronym / sponsor ID
- NHREC/16/05/22/185
- Conditions
- Complication, Postoperative
- Keywords
- Caesarean section, Post-operative feeding, Paralytic ileus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Darlington-Peter Chibuzor UgojiUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open labeled equivalence randomized control trial
| Arm | Type | Receives |
|---|---|---|
| EARLY FEEDING GROUP | Experimental | Other: Early feeding post caesarean sectionIn 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 | Active comparator | Other: Early feeding post caesarean sectionParticipants 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) |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early feeding post caesarean sectionIn 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 GROUP, TRADITIONAL FEEDING GROUP |
Primary outcome
Rate of tolerability of oral sips
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Results publicationMamah 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.
- Individual participant dataSharing planned: No. This will be following publication
Related trials for Complication
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DARLINTON-PETER CHIBUZOR C UGOJI, MBBS principal investigator
Alex Ekwueme Federal University Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early feeding post caesarean section in people with Complication and Postoperative, run by Darlington-Peter Chibuzor Ugoji at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of tolerability of oral sips (time frame: 48hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06539117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.