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

Not Applicable

• Conditions: Cesarean Section Complications
• Interventions: Procedure: early feeding; Procedure: delayed feeding

• Registration Number: NCT03070795
• Lead Sponsor: University of Ghana Medical School

Brief 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.

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 Timeline

• Study First Submitted: 2017-02-17
• Study Start: 2017-02-23
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-06
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-10
• Primary Completion: 2017-06-20
• Study Completion: 2017-08-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 170

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early feeding	early feeding	patients undergoing elective cesarean section will be allowed to feed (sips) four hours after cesarean section.
delayed feeding	delayed feeding	patients undergoing elective cesarean section will be allowed to feed on post operation day 1 (12 hours post op).

Primary Outcome Measures

Name	Time	Method
post-operative ileus	within 3 days after surgery	onset of vomiting \>4 times per day

Secondary Outcome Measures

Name	Time	Method
Crampy abdominal pain	within 3 days after surgery	abdominal pain after feeding following cesarean section
Time of initiation of breastfeeding post operatively	within 3 days after surgery	time it takes to start breastfeeding after cesrean section
Woman's satisfaction	within 3 days after surgery	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.
Time of ambulation out of bed after surgery	within 3 days after surgery	time it takes for the mother to get out of bed and sit up or mobilize
Incedence of a wound infection	within 2 weeks of surgery	measure of the presence of wound infection in both arms on day of discharge and 2 weeks post discharge

Trial Locations

Locations (1)

Korle-Bu Teaching Hospital; 🇬🇭 Accra, Greater Accra, Ghana