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

NCT ID: NCT03070795

Last Updated: 2017-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-23

Study Completion Date

2017-08-20

Brief Summary

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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

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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.

Conditions

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Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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early feeding

patients undergoing elective cesarean section will be allowed to feed (sips) four hours after cesarean section.

Group Type EXPERIMENTAL

early feeding

Intervention Type PROCEDURE

start oral sips four hours after cesarean section

delayed feeding

patients undergoing elective cesarean section will be allowed to feed on post operation day 1 (12 hours post op).

Group Type ACTIVE_COMPARATOR

delayed feeding

Intervention Type PROCEDURE

start oral feeding on post operation day 1 (\>12hours) after surgery

Interventions

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early feeding

start oral sips four hours after cesarean section

Intervention Type PROCEDURE

delayed feeding

start oral feeding on post operation day 1 (\>12hours) after surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ghana Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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kojo apea-kubi

Role: PRINCIPAL_INVESTIGATOR

Korle Bu Teaching Hospital

isaac abiaw

Role: PRINCIPAL_INVESTIGATOR

Korle Bu Teaching Hospital

Locations

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Korle-Bu Teaching Hospital

Accra, Greater Accra Region, Ghana

Site Status RECRUITING

Countries

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Ghana

Central Contacts

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Kojo A. Apea-Kubi, MBChB, MGCPS

Role: CONTACT

0264625142 ext. +233

mustapha salifu

Role: CONTACT

0243407809

Facility Contacts

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mustapha salifu

Role: primary

+233 243407809

mustapha salifu

Role: backup

+233 302 666 766

Other Identifiers

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KBTH - IRB /00065/2016

Identifier Type: -

Identifier Source: org_study_id

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