Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-03 @ 2:03 PM
Study NCT ID:
NCT03349151
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2017-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Results of Early Versus On-demand Maternal Feeding After Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomised'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-09', 'studyFirstSubmitDate': '2017-11-14', 'studyFirstSubmitQcDate': '2017-11-18', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'On postoperative day 2 before they are discharged from the hospital.', 'description': 'The primary outcome is patient satisfaction before discharge from hospital, measured using a scale called visual analogue scale (VAS). It is a 100-mm long scale with adjectival descriptions at both end positions. There will be a statement explaining what was intended to measure. Participants will be asked to mark the VAS on the second they of the surgery before they are discharged from the hospital. On this scale 0= lack of satisfaction from the timing of having their meal after the surgery 100= full satisfaction from the timing of their meal after the surgery.'}], 'secondaryOutcomes': [{'measure': 'Postoperative passage of flatus and defecation', 'timeFrame': 'Postoperative day 0 to day 2.', 'description': 'The participants will be asked to inform the nurse when they have their first passage of flatus and defecation.'}, {'measure': 'Postoperative gastrointestinal complaints', 'timeFrame': 'Thirty minutes after the surgery', 'description': 'Thirty minutes after the surgery the nurse will question the patients if they have a complaint of nausea, vomiting or abdominal distention.'}, {'measure': 'Postoperative pain medication', 'timeFrame': 'Postoperative from day 0 to day 2', 'description': 'After the surgery the need for pain medication will be followed. The name of the medicine, the time when the pain killer was used, the dosage of the medicine will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative maternal feeding, cesarean section'], 'conditions': ['Cesarean Delivery', 'Feeding Patterns', 'Patient Satisfaction', 'Postoperative Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '12431715', 'type': 'BACKGROUND', 'citation': 'Bisgaard T, Kehlet H. Early oral feeding after elective abdominal surgery--what are the issues? Nutrition. 2002 Nov-Dec;18(11-12):944-8. doi: 10.1016/s0899-9007(02)00990-5.'}, {'pmid': '12137699', 'type': 'BACKGROUND', 'citation': 'Mangesi L, Hofmeyr GJ. Early compared with delayed oral fluids and food after caesarean section. Cochrane Database Syst Rev. 2002;2002(3):CD003516. doi: 10.1002/14651858.CD003516.'}, {'pmid': '24856433', 'type': 'BACKGROUND', 'citation': 'Masood SN, Masood Y, Naim U, Masood MF. A randomized comparative trial of early initiation of oral maternal feeding versus conventional oral feeding after cesarean delivery. Int J Gynaecol Obstet. 2014 Aug;126(2):115-9. doi: 10.1016/j.ijgo.2014.02.023. Epub 2014 Apr 29.'}, {'pmid': '25794417', 'type': 'BACKGROUND', 'citation': 'Wrench IJ, Allison A, Galimberti A, Radley S, Wilson MJ. Introduction of enhanced recovery for elective caesarean section enabling next day discharge: a tertiary centre experience. Int J Obstet Anesth. 2015 May;24(2):124-30. doi: 10.1016/j.ijoa.2015.01.003. Epub 2015 Jan 14.'}, {'pmid': '8684757', 'type': 'BACKGROUND', 'citation': 'Kramer RL, Van Someren JK, Qualls CR, Curet LB. Postoperative management of cesarean patients: the effect of immediate feeding on the incidence of ileus. Obstet Gynecol. 1996 Jul;88(1):29-32. doi: 10.1016/0029-7844(96)00131-7.'}]}, 'descriptionModule': {'briefSummary': "To compare early versus on demand maternal feeding after cesarean delivery regarding gastrointestinal complaints and patient's satisfaction.", 'detailedDescription': 'Two hundred uncomplicated singleton term pregnancies who had caesarean section under regional anaesthesia will be included in our trial. Patients will be randomized to a soft food diet (honey, skimmed cheese, soup, mashed potatoe, pudding, grissini) served on postoperative 2nd hour or whenever they wanted to eat on return to the ward. Thirty minutes after they eat their meal, nausea, vomiting, ileus and distention will be questioned. Participants will be provided with the visual analogue scale (VAS), which will be presented with a statement explaining what was intended to measure. Patient satisfaction before discharge from hospital will be recorded by the patient by using a 100-mm VAS (0= minimum satisfaction, 100= maximum satisfaction). Time to first flatus passage and defecation will be recorded after the caesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uncomplicated singleton term pregnancy\n* Planned or intrapartum uncomplicated cesarean section\n* Cesarean section under regional anesthesia\n\nExclusion Criteria:\n\n* General anesthesia\n* History of bowel surgery\n* Prenatal diagnosis of fetal anomaly\n* Maternal disease\n* Intraoperative or immediate postoperative major complications'}, 'identificationModule': {'nctId': 'NCT03349151', 'briefTitle': 'Postoperative Results of Early Versus On-demand Maternal Feeding After Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'Postoperative Results of Early Versus On-demand Maternal Feeding After Cesarean Delivery', 'orgStudyIdInfo': {'id': 'ATADEK-2017/4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early feeding', 'description': 'This group will be served soft meal diet served on postoperative 2nd hour on return to the ward.', 'interventionNames': ['Behavioral: Early feeding']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'On- demand feeding', 'description': 'This group will be served soft meal diet served whenever they wanted to eat on return to the ward.', 'interventionNames': ['Behavioral: On- Demand feeding']}], 'interventions': [{'name': 'Early feeding', 'type': 'BEHAVIORAL', 'description': 'Feeding on postoperative 2nd hour on return to the ward', 'armGroupLabels': ['Early feeding']}, {'name': 'On- Demand feeding', 'type': 'BEHAVIORAL', 'description': 'Feeding whenever the patient asks for on return to the ward', 'armGroupLabels': ['On- demand feeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34457', 'city': 'Istanbul', 'state': 'Sariyer', 'country': 'Turkey (Türkiye)', 'facility': 'Acibadem Maslak Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Mete Gungor, MD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Acibadem MAA University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study protocol, statistical analysis plan might be shared when the study is completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor', 'investigatorFullName': 'Esra Ozbasli', 'investigatorAffiliation': 'Acibadem University'}}}}