Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT04530851
Status:
COMPLETED
Last Update Posted:
2020-08-28
First Post:
2020-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Compare Outcome of Enhanced Recovery After Cesarean Surgery and Conventional Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-25', 'studyFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2020-08-25', 'lastUpdatePostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare length of stay of pregnant women after Cesarean section between ERAS protocol and conventional care', 'timeFrame': '1 year', 'description': 'The primary outcome is length of stay (Day)'}], 'secondaryOutcomes': [{'measure': 'Compare pain of pregnant women after Cesarean section between ERAS protocol and conventional care', 'timeFrame': '1 year', 'description': 'The outcome is pain score (visual analogue scale )'}, {'measure': 'Compare opioid use of pregnant women after Cesarean section between ERAS protocol and conventional care', 'timeFrame': '1 year', 'description': 'The outcome are opioid use (Meperidine, Tramadol, Morphine)'}, {'measure': 'Compare complication of pregnant women after Cesarean section between ERAS protocol and conventional care', 'timeFrame': '1 year', 'description': 'The outcome are complication after surgery such as fever, wound infection, wound dehiscence, metritis'}, {'measure': 'Compare bowel function of pregnant women after Cesarean section between ERAS protocol and conventional care', 'timeFrame': '1 year', 'description': 'The outcome is time to passing gas after surgery(hour)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERAS', 'Cesarean section', 'Length of stay'], 'conditions': ['To Determine Whether ERAS Can Reduce Length of Stay in Pregnant Women After Cesarean Section']}, 'descriptionModule': {'briefSummary': 'Research objective to compare outcome(Length of stay, pain score, opioid drug use, Bowel function and complication ) of ERAS protocol and conventional care in pregnant women after elective cesarean section in Rajavithi hospital.', 'detailedDescription': "Research design is Randomized control trial. The pregnant women who go to elective cesarean section don't know the allocation. The group of ERAS protocol was separated from Conventional care in patient care unit.\n\nThe Pregnant are randomly in two group. In the ERAS group the pregnant receive the the intervention for preoperative care(Counselin, H2- antagonist and metroclopramide for prevent aspiration, Drink clear liquid until 2 hour before surgery), Intraoperative care (first generation cephalosporin in 60 minute before surgery, Clorhexidine for skin cleansing and Povidine for vaginal cleansing, regional anesthesia, keep warming, blunt expansion of uterine incision, do not peritoneal suture and subcuticular suture if less than 2 cm, local wound anesthesia.), post operative care ( Paracetamol and NSAIDs for for pain control, early remove catheter and ambulation, 5-HT3 antagonist for prevent nausea)"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women who scheduled for elective Cesarean section at Rajavithi Hospital\n\nExclusion Criteria:\n\n* Pregnant women who has preeclampsia with severe feature\n* Pregnant women who has diabetes mellitus with uncontrolled blood sugar\n* Pregnant women who has blood loss \\> 1,500 ml after surgery\n* Pregnant women who has chrioamnionitis.\n* Pregnant women who has severe medical disease\n* Pregnant women who has BMI \\>= 40 kg/m2\n* Pregnant women who has placenta adherence.'}, 'identificationModule': {'nctId': 'NCT04530851', 'briefTitle': 'Compare Outcome of Enhanced Recovery After Cesarean Surgery and Conventional Care', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Department of Medical Services Ministry of Public Health of Thailand'}, 'officialTitle': 'Compare Outcome of Enhanced Recovery After Cesarean Surgery and Conventional Care in Rajavithi Hospital', 'orgStudyIdInfo': {'id': '103/2562'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventional care', 'description': 'This group is conventional care of pregnant women after Cesarean section'}, {'type': 'EXPERIMENTAL', 'label': 'ERAS protocol', 'description': 'This protocol for improve outcome of pregnant women after Cesarean section', 'interventionNames': ['Procedure: ERAS']}], 'interventions': [{'name': 'ERAS', 'type': 'PROCEDURE', 'description': '* Counseling\n* H2- antagonist and metroclopramide for prevent aspiration\n* Drink clear liquid until 2 hour before surgery\n* First generation cephalosporin in 60 minute before surgery\n* Clorhexidine for skin cleansing and Povidine for vaginal cleansing\n* Regional anesthesia\n* Keep warming\n* Blunt expansion of uterine incision\n* Do not peritoneal suture and subcuticular suture if less than 2 cm\n* Local wound anesthesia.\n* Paracetamol and NSAIDs for for pain control\n* Early remove catheter and ambulation\n* 5-HT3 antagonist for prevent nausea', 'armGroupLabels': ['ERAS protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Rajavithi hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Department of Medical Services Ministry of Public Health of Thailand', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}