Outcomes of Early Versus Delayed Oral Feeding After Cesarean Section in Korle-bu Teaching Hospital

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.

Study Overview

• Status: Unknown
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Procedure: early feeding; Procedure: delayed feeding

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 Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Greater Accra
    • Accra, Greater Accra, Ghana
      • Recruiting
      • Korle-Bu Teaching Hospital
      • Contact: mustapha salifu; Phone Number: +233 243407809
      • Contact: mustapha salifu; Phone Number: +233 302 666 766; Email: rdo@kbth.gov.gh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 49 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Uncomplicated elective Cesarean sections performed under regional anaesthesia without extensive intra operative bowel adhesions.

Women who give consent to participate in the study.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: early feeding; patients undergoing elective cesarean section will be allowed to feed (sips) four hours after cesarean section.	Procedure: early feeding; start oral sips four hours after cesarean section
ACTIVE_COMPARATOR: delayed feeding; patients undergoing elective cesarean section will be allowed to feed on post operation day 1 (12 hours post op).	Procedure: delayed feeding; start oral feeding on post operation day 1 (>12hours) after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative ileus	onset of vomiting >4 times per day	within 3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crampy abdominal pain	abdominal pain after feeding following cesarean section	within 3 days after surgery
Time of initiation of breastfeeding post operatively	time it takes to start breastfeeding after cesrean section	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.	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	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	within 2 weeks of surgery

Collaborators and Investigators

• Sponsor: University of Ghana Medical School
• Investigators: Principal Investigator: kojo apea-kubi, Korle Bu Teaching Hospital; Principal Investigator: isaac abiaw, Korle Bu Teaching Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 23, 2017
• Primary Completion (ANTICIPATED): June 20, 2017
• Study Completion (ANTICIPATED): August 20, 2017

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (ACTUAL): March 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: early feeding; delayed feeding; post-operative ileus
• Other Study ID Numbers: KBTH - IRB /00065/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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