Cesarean Section ComplicationsNCT03070795
Outcomes of Early Versus Delayed Oral Feeding After Cesarean Section in Korle-bu Teaching Hospital
A study testing early feeding and delayed feeding in people with Cesarean Section Complications, run by University of Ghana Medical School at 1 site in Ghana.
Trial summary
study compares the outcomes of feeding mothers early (4 hours ) after cesarean section compared to delayed feeding (on post operation day 1) in terms of gastrointestinal function and maternal satisfaction with the feeding schedule. Read more about this study
- Who is it for?
- Ages Up to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- early feeding and delayed feeding
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteGhana
- Study dates
- 23 Feb 2017to 20 Aug 2017
- 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 Up to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Uncomplicated elective Cesarean sections performed under regional anaesthesia without extensive intra operative bowel adhesions.
- Women who give consent to participate in the study.
Who cannot join
- Elective Cesarean sections complicated by severe haemorrhage, bowel injury requiring bowel manipulation, repair, resection and anastomosis or colostomy.
- Women who require a Cesarean hysterectomy. Women who require a Post-partum hysterectomy. Mothers with severe pre-eclampsia. Mothers with sickle cell disease. Mothers with pregestational or gestational diabetes. Mothers who have been scheduled for Cesarean section and require general anaesthesia.
- Women who have had a previous laparotomy other than a Cesarean section.
Trial locations and contacts
1 site in 1 country.
mustapha salifu contact
Ghana1 site, 1 recruiting
- Recruiting
Korle-Bu Teaching Hospital
Accra, Greater Accra Region
mustapha salifu, +233 243407809
mustapha salifu, +233 302 666 766, rdo@kbth.gov.gh
About this study
Official title: Outcomes of Early Versus Delayed Oral Feeding After Elective Cesarean Section in a Teaching Hospital in Ghana.
study compares the outcomes of feeding mothers early (4 hours ) after cesarean section compared to delayed feeding (on post operation day 1) in terms of gastrointestinal function and maternal satisfaction with the feeding schedule.
Read the detailed description
patients who are scheduled to undergo elective cesarean section are randomised to two groups, one group will be allowed to feed 4 hours after cesarean section while the other group will be fed traditionally by feeding on the first post op day. gastrointestinal signs and symptoms will be measured such as post operative ileus, vomiting, nausea, abdminal distension. other parameters to be measured include time to ambulate out of bed after surgery, time to start breastfeeding after surgery. satisfaction with both feeding regimes will be assessed after surgery and the incedence of wound infecion will be compared between the two groups after two weeks durung the post natal review.
- Conditions
- Cesarean Section Complications
- Being tested
- early feeding, delayed feeding
- Keywords
- post-operative ileus, early feeding, delayed feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early feedingProcedure or surgery
start oral sips four hours after cesarean section
delayed feedingProcedure or surgery
start oral feeding on post operation day 1 (>12hours) after surgery
| Study group | Role | What they receive |
|---|---|---|
| early feeding | Experimental | patients undergoing elective cesarean section will be allowed to feed (sips) four hours after cesarean section. Receives: Procedure: early feeding |
| delayed feeding | Active comparator | patients undergoing elective cesarean section will be allowed to feed on post operation day 1 (12 hours post op). Receives: Procedure: delayed feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative ileus
onset of vomiting >4 times per day
Measured: within 3 days after surgery
Secondary outcomes (5)
Crampy abdominal pain
abdominal pain after feeding following cesarean section
Measured: within 3 days after surgery
Time of initiation of breastfeeding post operatively
time it takes to start breastfeeding after cesrean section
Measured: within 3 days after surgery
Woman's satisfaction
measure level of satisfaction with feeding regime using an assessment scoring tool. this is in the form of a questionair adminstered to the client by the investigator.
Measured: within 3 days after surgery
Time of ambulation out of bed after surgery
time it takes for the mother to get out of bed and sit up or mobilize
Measured: within 3 days after surgery
Incedence of a wound infection
measure of the presence of wound infection in both arms on day of discharge and 2 weeks post discharge
Measured: within 2 weeks of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start23 Feb 2017
- Primary completion20 Jun 2017 (estimated)
- Study completion20 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ghana Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- kojo apea-kubi, Principal investigator, Korle Bu Teaching Hospitalisaac abiaw, Principal investigator, Korle Bu Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070795
- Sponsor's protocol ID
- KBTH - IRB /00065/2016
- Status last verified
- Mar 2017
- First submitted
- 17 Feb 2017
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Early Versus Delayed Oral Feeding After Elective Cesarean Section in a Teaching Hospital in Ghana.
- ClinicalTrials.gov ID
- NCT03070795
- Acronym / sponsor ID
- KBTH - IRB /00065/2016
- Conditions
- Cesarean Section Complications
- Keywords
- post-operative ileus, early feeding, delayed feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University of Ghana Medical SchoolUniversity, hospital or other
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 20 Jun 2017 (estimated)
- Study completion
- 20 Aug 2017 (estimated)
- First posted
- 6 Mar 2017 (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.
study compares the outcomes of feeding mothers early (4 hours ) after cesarean section compared to delayed feeding (on post operation day 1) in terms of gastrointestinal function and maternal satisfaction with the feeding schedule.
Detailed description
patients who are scheduled to undergo elective cesarean section are randomised to two groups, one group will be allowed to feed 4 hours after cesarean section while the other group will be fed traditionally by feeding on the first post op day. gastrointestinal signs and symptoms will be measured such as post operative ileus, vomiting, nausea, abdminal distension. other parameters to be measured include time to ambulate out of bed after surgery, time to start breastfeeding after surgery. satisfaction with both feeding regimes will be assessed after surgery and the incedence of wound infecion will be compared between the two groups after two weeks durung the post natal review.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early feeding | Experimental | Procedure: early feedingpatients undergoing elective cesarean section will be allowed to feed (sips) four hours after cesarean section. |
| delayed feeding | Active comparator | Procedure: delayed feedingpatients undergoing elective cesarean section will be allowed to feed on post operation day 1 (12 hours post op). |
Who may qualify
- Ages
- Up to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Uncomplicated elective Cesarean sections performed under regional anaesthesia without extensive intra operative bowel adhesions.
- Women who give consent to participate in the study.
Key exclusion criteria (3 listed)
- Elective Cesarean sections complicated by severe haemorrhage, bowel injury requiring bowel manipulation, repair, resection and anastomosis or colostomy.
- Women who require a Cesarean hysterectomy. Women who require a Post-partum hysterectomy. Mothers with severe pre-eclampsia. Mothers with sickle cell disease. Mothers with pregestational or gestational diabetes. Mothers who have been scheduled for Cesarean section and require general anaesthesia.
- Women who have had a previous laparotomy other than a Cesarean section.
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 feedingstart oral sips four hours after cesarean section | Procedure or surgery | early feeding |
| delayed feedingstart oral feeding on post operation day 1 (>12hours) after surgery | Procedure or surgery | delayed feeding |
Primary outcome
post-operative ileus
Time frame: within 3 days after surgery
onset of vomiting >4 times per day
5 secondary outcomes
Crampy abdominal pain
Time frame: within 3 days after surgery
Time of initiation of breastfeeding post operatively
Time frame: within 3 days after surgery
Woman's satisfaction
Time frame: within 3 days after surgery
Time of ambulation out of bed after surgery
Time frame: within 3 days after surgery
Incedence of a wound infection
Time frame: within 2 weeks of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
mustapha salifu contact
kojo apea-kubi principal investigator
Korle Bu Teaching Hospital
isaac abiaw principal investigator
Korle Bu 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 and delayed feeding in people with Cesarean Section Complications, run by University of Ghana Medical School at 1 site in Ghana.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Mar 2017. 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 Ghana. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kojo A. Apea-Kubi, MBChB, MGCPS (0264625142 ext. +233, kojoapeakubi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative ileus (time frame: within 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2017.