Outcomes of Early Versus Delayed Oral Feeding After Cesarean Section in Korle-bu Teaching Hospital
1 other identifier
interventional
170
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2017
CompletedStudy Start
First participant enrolled
February 23, 2017
CompletedFirst Posted
Study publicly available on registry
March 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2017
CompletedMarch 10, 2017
March 1, 2017
4 months
February 17, 2017
March 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
post-operative ileus
onset of vomiting \>4 times per day
within 3 days after surgery
Secondary Outcomes (5)
Crampy abdominal pain
within 3 days after surgery
Time of initiation of breastfeeding post operatively
within 3 days after surgery
Woman's satisfaction
within 3 days after surgery
Time of ambulation out of bed after surgery
within 3 days after surgery
Incedence of a wound infection
within 2 weeks of surgery
Study Arms (2)
early feeding
EXPERIMENTALpatients undergoing elective cesarean section will be allowed to feed (sips) four hours after cesarean section.
delayed feeding
ACTIVE COMPARATORpatients undergoing elective cesarean section will be allowed to feed on post operation day 1 (12 hours post op).
Interventions
start oral feeding on post operation day 1 (\>12hours) after surgery
Eligibility Criteria
You may qualify if:
- Uncomplicated elective Cesarean sections performed under regional anaesthesia without extensive intra operative bowel adhesions.
- Women who give consent to participate in the study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korle-Bu Teaching Hospital
Accra, Greater Accra Region, Ghana
Study Officials
- PRINCIPAL INVESTIGATOR
kojo apea-kubi
Korle Bu Teaching Hospital
- PRINCIPAL INVESTIGATOR
isaac abiaw
Korle Bu Teaching Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2017
First Posted
March 6, 2017
Study Start
February 23, 2017
Primary Completion
June 20, 2017
Study Completion
August 20, 2017
Last Updated
March 10, 2017
Record last verified: 2017-03