Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-02-22 @ 7:25 AM
Study NCT ID:
NCT03070795
Status:
UNKNOWN
Last Update Posted:
2017-03-10
First Post:
2017-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Early Versus Delayed Oral Feeding After Cesarean Section in Korle-bu Teaching Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-07', 'studyFirstSubmitDate': '2017-02-17', 'studyFirstSubmitQcDate': '2017-03-03', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-operative ileus', 'timeFrame': 'within 3 days after surgery', 'description': 'onset of vomiting \\>4 times per day'}], 'secondaryOutcomes': [{'measure': 'Crampy abdominal pain', 'timeFrame': 'within 3 days after surgery', 'description': 'abdominal pain after feeding following cesarean section'}, {'measure': 'Time of initiation of breastfeeding post operatively', 'timeFrame': 'within 3 days after surgery', 'description': 'time it takes to start breastfeeding after cesrean section'}, {'measure': "Woman's satisfaction", 'timeFrame': 'within 3 days after surgery', 'description': '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.'}, {'measure': 'Time of ambulation out of bed after surgery', 'timeFrame': 'within 3 days after surgery', 'description': 'time it takes for the mother to get out of bed and sit up or mobilize'}, {'measure': 'Incedence of a wound infection', 'timeFrame': 'within 2 weeks of surgery', 'description': 'measure of the presence of wound infection in both arms on day of discharge and 2 weeks post discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post-operative ileus', 'early feeding', 'delayed feeding'], 'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nUncomplicated elective Cesarean sections performed under regional anaesthesia without extensive intra operative bowel adhesions.\n\nWomen who give consent to participate in the study.\n\nExclusion Criteria:\n\n* Elective Cesarean sections complicated by severe haemorrhage, bowel injury requiring bowel manipulation, repair, resection and anastomosis or colostomy.\n\nWomen 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.\n\nWomen who have had a previous laparotomy other than a Cesarean section.'}, 'identificationModule': {'nctId': 'NCT03070795', 'briefTitle': 'Outcomes of Early Versus Delayed Oral Feeding After Cesarean Section in Korle-bu Teaching Hospital', 'organization': {'class': 'OTHER', 'fullName': 'University of Ghana Medical School'}, 'officialTitle': 'Outcomes of Early Versus Delayed Oral Feeding After Elective Cesarean Section in a Teaching Hospital in Ghana.', 'orgStudyIdInfo': {'id': 'KBTH - IRB /00065/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'early feeding', 'description': 'patients undergoing elective cesarean section will be allowed to feed (sips) four hours after cesarean section.', 'interventionNames': ['Procedure: early feeding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'delayed feeding', 'description': 'patients undergoing elective cesarean section will be allowed to feed on post operation day 1 (12 hours post op).', 'interventionNames': ['Procedure: delayed feeding']}], 'interventions': [{'name': 'early feeding', 'type': 'PROCEDURE', 'description': 'start oral sips four hours after cesarean section', 'armGroupLabels': ['early feeding']}, {'name': 'delayed feeding', 'type': 'PROCEDURE', 'description': 'start oral feeding on post operation day 1 (\\>12hours) after surgery', 'armGroupLabels': ['delayed feeding']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Accra', 'state': 'Greater Accra Region', 'status': 'RECRUITING', 'country': 'Ghana', 'contacts': [{'name': 'mustapha salifu', 'role': 'CONTACT', 'phone': '+233 243407809'}, {'name': 'mustapha salifu', 'role': 'CONTACT', 'email': 'rdo@kbth.gov.gh', 'phone': '+233 302 666 766'}], 'facility': 'Korle-Bu Teaching Hospital', 'geoPoint': {'lat': 5.55602, 'lon': -0.1969}}], 'centralContacts': [{'name': 'Kojo A. Apea-Kubi, MBChB, MGCPS', 'role': 'CONTACT', 'email': 'kojoapeakubi@gmail.com', 'phone': '0264625142', 'phoneExt': '+233'}, {'name': 'mustapha salifu', 'role': 'CONTACT', 'phone': '0243407809'}], 'overallOfficials': [{'name': 'kojo apea-kubi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korle Bu Teaching Hospital'}, {'name': 'isaac abiaw', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korle Bu Teaching Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ghana Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}