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

Cesarean Section Complications Clinical Trial

Official title:

Outcomes of Early Versus Delayed Oral Feeding After Elective Cesarean Section in a Teaching Hospital in Ghana.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03070795
• Other study ID #: KBTH - IRB /00065/2016
• Status: Recruiting
• Phase: N/A
• First received: February 17, 2017
• Last updated: March 7, 2017
• Start date: February 23, 2017
• Est. completion date: August 20, 2017

Study information

• Verified date: March 2017
• Source: University of Ghana Medical School
• Contact: Kojo A. Apea-Kubi, MBChB, MGCPS
• Phone: 0264625142
• Email: kojoapeakubi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: August 20, 2017
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Procedure:
• early feeding
start oral sips four hours after cesarean section
• delayed feeding
start oral feeding on post operation day 1 (>12hours) after surgery

Locations

Country	Name	City	State
Ghana	Korle-Bu Teaching Hospital	Accra	Greater Accra

Sponsors (1)

Lead Sponsor	Collaborator
University of Ghana Medical School

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-operative ileus	onset of vomiting >4 times per day	within 3 days after surgery
Secondary	Crampy abdominal pain	abdominal pain after feeding following cesarean section	within 3 days after surgery
Secondary	Time of initiation of breastfeeding post operatively	time it takes to start breastfeeding after cesrean section	within 3 days after surgery
Secondary	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
Secondary	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
Secondary	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