Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:56 AM
Study NCT ID:
NCT03442634
Status:
COMPLETED
Last Update Posted:
2018-08-09
First Post:
2018-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Versus Traditional Oral Hydration After Cesarean Section
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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2018-02-16', 'studyFirstSubmitQcDate': '2018-02-21', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'audible intestinal sounds', 'timeFrame': 'first 12 hours after cesarean section', 'description': 'auscultation of intestinal sounds hourly for the first 12 hours after cesarean section'}], 'secondaryOutcomes': [{'measure': 'postoperative anorexia, nausea and vomiting', 'timeFrame': 'first 24 hours after cesarean section', 'description': 'recording the incidence of git upset symptoms in the first 24 hours after cesarean section'}, {'measure': 'time for first breast feeding', 'timeFrame': 'first 24 hours after cesarean section', 'description': 'recording the time of first breast-feed'}, {'measure': 'abdominal distension', 'timeFrame': 'first 24 hours after cesarean section', 'description': 'recording the incidence of abdominal distension after cesarean section'}, {'measure': 'amount of given intravenous fluids', 'timeFrame': 'up to 24 hours after cesarean section', 'description': 'recording amount in ml of given iv fluids'}, {'measure': 'need for pain analgesics', 'timeFrame': 'up to 24 hours after cesarean section', 'description': 'recording the amount of pain analgesia needed after cesarean section'}, {'measure': 'length of hospital stay', 'timeFrame': 'up to 48 hours after cesarean section', 'description': "recording the length of patients' stay at hospital"}, {'measure': 'satisfaction measured with a visual analogue scale before patient discharge', 'timeFrame': 'first 6 hours after cesarean section', 'description': 'measuring satisfaction level after cesarean section'}, {'measure': 'time to first flatus', 'timeFrame': 'up to 48 hours after cesarean section', 'description': 'recording the time at which the patient had its first flatus'}, {'measure': 'time to first bowel movement', 'timeFrame': 'up to 72 hours after cesarean section', 'description': 'recording the time at which the patient had her first bowel motion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bowel movements', 'cesarean section', 'oral hydration'], 'conditions': ['Gastrointestinal Motility and Defecation Conditions']}, 'descriptionModule': {'briefSummary': 'this study helps us to compare and evaluate prospectively the benefits and safety of early hydration on bowel movement after cesarean section it includes two groups, a control group and a study group. the study group will get 200 ml of sugar free water within 1 hour after cs while the control group will get 200 ml of sugar free water 6 hours after cs', 'detailedDescription': 'Traditionally, patients are not given fluids or food after cesarean sections until bowel function returns as evidenced by bowel sounds, passage of stool or flatus since , uneventful (uncomplicated) cesarean sections have no effect on intestinal functions and with putting in minds the need of the mother for early hydration , movement , breast feeding and early discharge; that is why we are investigating the effectiveness and safety of early oral hydration after cesarean sections'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Term Singleton Pregnancy.\n* Uncomplicated Elective Cesarean Section.\n* Time of Cesarean Section doesn't exceed 90 minutes.\n* Average blood loss during and after cesarean section (doesn't exceed 1000cc).\n* All patients will be under spinal anesthesia.\n\nExclusion Criteria:\n\n* Postpartum Hemorrhage.\n* Surgical Complications Such as intestinal injury.\n* Medical disorders such as Diabetes and Hypertension\n* Factors that may influence postpartum blood loss as anemia, multiple pregnancy and polyhydraminos.\n* Use of tocolytic drugs"}, 'identificationModule': {'nctId': 'NCT03442634', 'briefTitle': 'Early Versus Traditional Oral Hydration After Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Early Versus Traditional Oral Hydration After Cesarean Section; A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'cshydration'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Hydration Group', 'description': "this study group will get 200 ml of sugar free water within 1 hour after cesarean section followed by oral hydration as per patients' desire then starting semisolid and solid foods when patients are open bowel Intervention: Early Oral Hydration", 'interventionNames': ['Other: Early Hydration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Hydration Group', 'description': "this study group will get 200 ml of sugar free water after 6 hours after cesarean section followed by oral hydration as per patients' desire then starting semisolid and solid foods when patients are open bowel Intervention: Traditional Oral Hydration", 'interventionNames': ['Other: Traditional Oral Hydration']}], 'interventions': [{'name': 'Early Hydration', 'type': 'OTHER', 'otherNames': ['Early Oral Hydration'], 'description': 'this group will start oral hydration within 1 hour after cesarean section', 'armGroupLabels': ['Early Hydration Group']}, {'name': 'Traditional Oral Hydration', 'type': 'OTHER', 'otherNames': ['Delayed Oral Hydration'], 'description': 'this group will start oral hydration 6 hours after cesarean section', 'armGroupLabels': ['Traditional Hydration Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Bassem A Islam, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams Maternity Hospital'}, {'name': 'Karim A Wahba, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams Maternity Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Obstetrics and Gynaecology Resident', 'investigatorFullName': 'Mohamed Hassan Mohamed Mostafa', 'investigatorAffiliation': 'Ain Shams University'}}}}