Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-28 @ 11:18 AM
Study NCT ID:
NCT02129894
Status:
UNKNOWN
Last Update Posted:
2014-05-02
First Post:
2014-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Abdominal Binders in Patients Undergoing Cesarean Sections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2016-04-14', 'unreleaseDateUnknown': True}, {'resetDate': '2016-05-24', 'releaseDate': '2016-04-18'}, {'resetDate': '2021-08-06', 'releaseDate': '2021-07-15'}], 'estimatedResultsFirstSubmitDate': '2016-04-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-01', 'studyFirstSubmitDate': '2014-04-30', 'studyFirstSubmitQcDate': '2014-05-01', 'lastUpdatePostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain measurement', 'timeFrame': 'up to post operateive day 2', 'description': 'Pain will be measured using a visual analog scale'}, {'measure': 'Patient Distress score', 'timeFrame': 'up to post operateive day 2', 'description': 'A validated patient distress score will be used'}], 'secondaryOutcomes': [{'measure': 'hemoglobin and hematocrit', 'timeFrame': 'post operative day 1 and 2'}, {'measure': 'Pain medication usage', 'timeFrame': 'post operative day 1 and 2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cesarean section', 'postoperative pain', 'pregnancy', 'abdominal binder'], 'conditions': ['Cesarean Section Post Operative Management']}, 'referencesModule': {'references': [{'pmid': '32871021', 'type': 'DERIVED', 'citation': 'Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.'}, {'pmid': '26892694', 'type': 'DERIVED', 'citation': 'Gillier CM, Sparks JR, Kriner R, Anasti JN. A randomized controlled trial of abdominal binders for the management of postoperative pain and distress after cesarean delivery. Int J Gynaecol Obstet. 2016 May;133(2):188-91. doi: 10.1016/j.ijgo.2015.08.026. Epub 2016 Jan 14.'}]}, 'descriptionModule': {'briefSummary': 'To see if the use of Abdominal Binders improves patients out comes after cesarean delivery', 'detailedDescription': 'Inclusion: All patients admitted to labor and delivery\n\nConsented patients who had a cesarean delivery will be randomized using a number table to receive or not receive an abdominal binder.\n\nOutcomes: On postoperative days 1 and 2, patients were asked to complete a pain visual analog scale and the validated Symptom Distress Scale. Postoperative hemoglobin and hematocrit were also recorded.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen undergoing cesarean section for any indication\n\nExclusion Criteria:\n\n* unable to give consent'}, 'identificationModule': {'nctId': 'NCT02129894', 'briefTitle': 'The Use of Abdominal Binders in Patients Undergoing Cesarean Sections', 'organization': {'class': 'OTHER', 'fullName': "St. Luke's Hospital, Pennsylvania"}, 'officialTitle': 'The Use of Abdominal Binders in Patients Undergoing Cesarean Sections: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SLHN-50-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'abdominal binder', 'description': 'Post cesarean section patients will get a abdominal binder placed', 'interventionNames': ['Device: abdominal Binder']}, {'type': 'NO_INTERVENTION', 'label': 'No Abdominal Binder', 'description': 'Post cesarean section patients will not have abdominal binder'}], 'interventions': [{'name': 'abdominal Binder', 'type': 'DEVICE', 'description': 'placement of abdominal binder', 'armGroupLabels': ['abdominal binder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James N Anasti, MD', 'role': 'CONTACT', 'email': 'anastij@slhn.org', 'phone': '484-526-4670'}, {'name': 'James N Anasti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St Luke's University Hospital", 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}], 'centralContacts': [{'name': 'James N Anasti, MD', 'role': 'CONTACT', 'email': 'anastij@slhn.org', 'phone': '484-526-4670'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Luke's Hospital, Pennsylvania", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-04-14', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2016-04-18', 'type': 'RELEASE'}, {'date': '2016-05-24', 'type': 'RESET'}, {'date': '2021-07-15', 'type': 'RELEASE'}, {'date': '2021-08-06', 'type': 'RESET'}], 'unpostedResponsibleParty': "St. Luke's Hospital, Pennsylvania"}}}}