Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT03041220
Status:
WITHDRAWN
Last Update Posted:
2023-08-14
First Post:
2017-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Best Incision Site for Obese Patients - Low Versus High Transverse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002585', 'term': 'Cesarean Section'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI no longer at institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-09', 'studyFirstSubmitDate': '2017-01-11', 'studyFirstSubmitQcDate': '2017-02-01', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type of skin incision', 'timeFrame': 'Delivery to 6 weeks postpartum', 'description': 'Identify which type of skin incision has better outcomes in obese pregnant patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cesarean Section']}, 'descriptionModule': {'briefSummary': "Retrospective chart review using both out patient and inpatient records of obese patients (BMI of 30 or greater) who have had a cesarean section since the year 2009. We will evaluate the patient's BMI, their skin incision type at time of c-section, their co-morbidities, number of previous c-sections and post partum follow up for wound infection, wound separation and wound breakdown. We will also review operative notes to evaluate blood loss, length of surgery and complications during surgery. We will obtain maternal characteristics and information about the pregnancy.", 'detailedDescription': "Past studies have looked primarily at vertical vs low transverse skin incision. There is data that performing a high transverse skin incision on obese patients leads to better visualization and less wound infection but there are few studies comparing it directly to low transverse skin incision.\n\nRetrospective chart review of obese patient's who have had a cesarean section at St Mary's hospital by either a low or high transverse skin incision between January 1, 2009 - July 31, 2014. We will review charts up to 6 week postpartum.\n\nPregnancies will be identified through identifing those who have cesarean sections. They will be narrowed down by those who have BMI of \\> 30. Maternal prenatal records, postnatal records and delivery records will be reviewed."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ages between 18 - 45 years, female, and no limitation on ethnic background.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obese patients (BMI of 30 or greater) who have had a cesarean section\n\nExclusion Criteria:\n\n* Vaginal delivery'}, 'identificationModule': {'nctId': 'NCT03041220', 'briefTitle': 'Best Incision Site for Obese Patients - Low Versus High Transverse', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Best Incision Site for Obese Patients - Low Versus High Transverse', 'orgStudyIdInfo': {'id': '24387'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cesarean section', 'description': 'Obese pregnant patients who have had a cesarean section.', 'interventionNames': ['Procedure: cesarean section']}], 'interventions': [{'name': 'cesarean section', 'type': 'PROCEDURE', 'description': 'obese patients (BMI of 30 or greater) who have had a cesarean section', 'armGroupLabels': ['cesarean section']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Heather Said, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Louis University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}