Clinical trial NCT03070795: Outcomes of Early Versus Delayed Oral Feeding After Cesarean Section in Korle-bu Teaching Hospital
Official title: Outcomes of Early Versus Delayed Oral Feeding After Elective Cesarean Section in a Teaching Hospital in Ghana.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Keywords: post-operative ileus
early feeding
delayed feeding
Lead sponsor: University of Ghana Medical School
Sponsor class: OTHER
First posted: 2017-03-06
Enrollment: 170
Sex: FEMALE
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: post-operative ileus
timeFrame: within 3 days after surgery
Secondary outcomes:
measure: Crampy abdominal pain
timeFrame: within 3 days after surgery
measure: Time of initiation of breastfeeding post operatively
timeFrame: within 3 days after surgery
measure: Woman's satisfaction
timeFrame: within 3 days after surgery
measure: Time of ambulation out of bed after surgery
timeFrame: within 3 days after surgery
measure: Incedence of a wound infection
timeFrame: within 2 weeks of surgery
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: Korle-Bu Teaching Hospital
state: Greater Accra
Study officials:
affiliation: Korle Bu Teaching Hospital
name: kojo apea-kubi
role: PRINCIPAL_INVESTIGATOR
affiliation: Korle Bu Teaching Hospital
name: isaac abiaw
role: PRINCIPAL_INVESTIGATOR
References: