Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
Study NCT ID:
NCT00697606
Status:
TERMINATED
Last Update Posted:
2015-12-30
First Post:
2008-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Seprafilm® for Prevention of Adhesions at Repeat Cesarean
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-02-01', 'releaseDate': '2015-12-30'}], 'estimatedResultsFirstSubmitDate': '2015-12-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000267', 'term': 'Tissue Adhesions'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}}, 'statusModule': {'whyStopped': 'lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-29', 'studyFirstSubmitDate': '2008-06-12', 'studyFirstSubmitQcDate': '2008-06-12', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine if Seprafilm® decreases the incidence of adhesion formation by 50% after primary cesarean.', 'timeFrame': 'at repeat cesarean'}], 'secondaryOutcomes': [{'measure': 'To determine to what extent Seprafilm® decreases the incidence of adhesion formation.', 'timeFrame': 'at repeat cesarean'}, {'measure': 'To determine the incidence of adhesion formation during repeat cesarean delivery.', 'timeFrame': 'at repeat cesarean'}, {'measure': 'To evaluate complication rates in those with Seprafilm® versus those without during repeat surgery by examining length of operating times, blood loss, bladder injuries, and Apgar scores', 'timeFrame': 'at repeat cesarean'}, {'measure': 'To determine the incidence of fertility issues in women having Seprafilm® placed during primary cesarean delivery versus those not having Seprafilm® placed. Participating women will be contacted by telephone every 4 months.', 'timeFrame': 'ongoing during trial'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Seprafilm®', 'cesarean', 'adhesions', 'primary', 'repeat'], 'conditions': ['Adhesion Formation After Primary Cesarean Delivery']}, 'descriptionModule': {'briefSummary': 'Adhesion formation is a result of abdominal and pelvic surgery and is a cause of such diseases as chronic pain syndrome, bowel obstruction and infertility. Both patients and surgeons suffer when adhesions are encountered, since the surgery becomes more intense, lengthy, and complicated. Seprafilm® has been shown to limit the formation of adhesions in gynecologic and abdominal surgery. Limited data is available on the effectiveness of Seprafilm® in the prevention of abdominal wall and pelvic adhesions at the time of cesarean section. Adhesions at the time of repeat cesarean make the surgery frustrating and complex, with difficult lysis of adhesions being the cause of morbidities such as bladder damage, increased blood loss, and longer operating times. The objective of this definitive project is to define the extent of reduction of adhesion formation of Seprafilm® when used at the time of primary cesarean section. Women undergoing primary cesarean section will be randomized for Seprafilm® application, and the incidence and grade of adhesions at repeat cesarean will be determined.', 'detailedDescription': 'This is a prospective randomized double-blinded study. Patients will be randomized prior to primary cesarean section to either the study arm (Seprafilm® placement) or control arm (nothing placed). Seprafilm® will be placed over the repaired uterine incision and over the anterior aspect of the uterus prior to closure of the fascia (2 to 3 sheets per patient). Randomization will be by opaque envelops containing group assignment.\n\nParticipants and surgeons will be blinded to group designation at the time of repeat cesarean. The surgeon will be asked to grade the adhesions at the time of repeat cesarean.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Pregnant women after 24 weeks' gestation.\n2. First cesarean delivery.\n3. Age \\> 18 years.\n4. Cesarean to be performed by a participating surgeon.\n5. Non-closure of the visceral or parietal peritoneum.\n\nExclusion Criteria:\n\n1. Any prior abdominal surgery including prior cesarean, laparoscopy, appendectomy, cholecystectomy or any uterine adnexal or bowel surgery.\n2. Clinical diagnosis of chorioamnionitis.\n3. Women having tubal ligation at the time of primary cesarean.\n4. Inability to obtain informed consent."}, 'identificationModule': {'nctId': 'NCT00697606', 'acronym': 'SPARC', 'briefTitle': 'Seprafilm® for Prevention of Adhesions at Repeat Cesarean', 'organization': {'class': 'OTHER', 'fullName': 'Abington Memorial Hospital'}, 'officialTitle': 'Randomized Double-Blind Controlled Study to Determine if Seprafilm® Reduces Adhesions After Primary Cesarean Section', 'orgStudyIdInfo': {'id': 'Study #08-032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Seprafilm®', 'interventionNames': ['Device: Seprafilm®']}, {'type': 'SHAM_COMPARATOR', 'label': 'B', 'description': 'Control', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Seprafilm®', 'type': 'DEVICE', 'description': 'Seprafilm® placed at time of primary cesarean', 'armGroupLabels': ['A']}, {'name': 'Control', 'type': 'OTHER', 'description': 'no Seprafilm® used at primary cesarean', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19001', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Memorial Hospital', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}], 'overallOfficials': [{'name': 'Amy Mackey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abington Memorial Hospital'}, {'name': 'Mark Shahin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abington Memorial Hospital'}, {'name': 'Richard Latta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abington Memorial Hospital'}, {'name': 'David Peleg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abington Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abington Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'David Peleg, MD', 'investigatorAffiliation': 'Abington Memorial Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-12-30', 'type': 'RELEASE'}, {'date': '2016-02-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'David Peleg, MD, Principle Investigator, Abington Memorial Hospital'}}}}