Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-24 @ 9:53 PM
Study NCT ID:
NCT02685761
Status:
UNKNOWN
Last Update Posted:
2016-09-13
First Post:
2016-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skin Incisions and Wound Complication Rates for C-sections in Obese Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 309}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-12', 'studyFirstSubmitDate': '2016-02-16', 'studyFirstSubmitQcDate': '2016-02-16', 'lastUpdatePostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound Complications', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obesity', 'Infection; Cesarean Section', 'Surgical Wound']}, 'descriptionModule': {'briefSummary': 'It is the purpose of this study to evaluate the relationship between a low transverse, vertical midline, and supra-panicular high transverse skin incisions and the rate of wound complications in women with a BMI of 40 or greater undergoing a cesarean section for delivery. So far, the choice of incision for the morbidly obese is based only on case reports. No randomized controlled trials have been done up to date comparing these methods. It is our hope that a high transverse incision will have all of the benefits of a low transverse skin incision, with the added benefit of better exposure offered by a vertical midline incision, without the added increased risk of subjecting the woman to a vertical hysterotomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pre-pregnancy BMI equal or greater than 40\n\nExclusion Criteria:\n\n* prior cesarean section or laparotomy'}, 'identificationModule': {'nctId': 'NCT02685761', 'briefTitle': 'Skin Incisions and Wound Complication Rates for C-sections in Obese Women', 'organization': {'class': 'OTHER', 'fullName': 'Albany Medical College'}, 'officialTitle': 'Randomized Controlled Trial of Wound Complication Rates Between Low Transverse, Midline Vertical, and High Transverse Skin Incisions in Women With a BMI of 40 or Above Undergoing a Cesarean Section for Delivery', 'orgStudyIdInfo': {'id': '4128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Low Transverse', 'description': 'Patients in this arm will undergo their cesarean section using the standard low transverse skin incision location'}, {'type': 'EXPERIMENTAL', 'label': 'Midline Vertical', 'description': 'Patients in this arm will undergo their cesarean section using a midline vertical skin incision', 'interventionNames': ['Procedure: Midline Vertical']}, {'type': 'EXPERIMENTAL', 'label': 'High Transverse', 'description': 'Patients in this arm will undergo their cesarean section using a high transverse skin incision, above the pannus', 'interventionNames': ['Procedure: High Transverse']}], 'interventions': [{'name': 'Midline Vertical', 'type': 'PROCEDURE', 'description': 'Cesarean section performed using a midline vertical skin incision, located between the umbilicus and pubis', 'armGroupLabels': ['Midline Vertical']}, {'name': 'High Transverse', 'type': 'PROCEDURE', 'description': 'Cesarean section performed using a transverse skin incision located above the pannus', 'armGroupLabels': ['High Transverse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12208', 'city': 'Albany', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter R Cole, MD', 'role': 'CONTACT', 'email': 'colep@mail.amc.edu', 'phone': '518-262-4942'}], 'facility': 'Albany Medical Center Obstetrics and Gynecology', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter R Cole, MD', 'role': 'CONTACT', 'email': 'colep@mail.amc.edu', 'phone': '528-264-1800'}], 'facility': 'Albany Medical Center Obstetrics and Gynecology', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter R Cole, MD', 'role': 'CONTACT', 'email': 'colep@mail.amc.edu', 'phone': '518-262-4131'}], 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '12020', 'city': 'Ballston Spa', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter R Cole, MD', 'role': 'CONTACT', 'email': 'colep@mail.amc.edu', 'phone': '518-262-1200'}], 'facility': 'Albany Medical Center Obstetrics and Gynecology', 'geoPoint': {'lat': 43.00091, 'lon': -73.84901}}, {'zip': '12065', 'city': 'Clifton Park', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter R Cole, MD', 'role': 'CONTACT', 'email': 'colep@mail.amc.edu', 'phone': '518-264-1900'}], 'facility': 'Albany Medical Center Obstetrics and Gynecology', 'geoPoint': {'lat': 42.86563, 'lon': -73.77095}}, {'zip': '12054', 'city': 'Delmar', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter R Cole, MD', 'role': 'CONTACT', 'email': 'colep@mail.amc.edu', 'phone': '518-264-0701'}], 'facility': 'Albany Medical Center Obstetrics and Gynecology', 'geoPoint': {'lat': 42.62202, 'lon': -73.83262}}, {'zip': '12110', 'city': 'Latham', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter R Cole, MD', 'role': 'CONTACT', 'email': 'colep@mail.amc.edu', 'phone': '518-264-5053'}], 'facility': 'Albany Medical Center Obstetrics and Gynecology', 'geoPoint': {'lat': 42.74702, 'lon': -73.75901}}], 'centralContacts': [{'name': 'Peter R Cole, MD', 'role': 'CONTACT', 'email': 'colep@mail.amc.edu', 'phone': '518-262-4942'}, {'name': 'Olga T Filippova, MD', 'role': 'CONTACT', 'email': 'filippo@mail.amc.edu', 'phone': '845-661-5716'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albany Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Divison of Gynecology, Department of OBGYN', 'investigatorFullName': 'Peter R Cole, MD', 'investigatorAffiliation': 'Albany Medical College'}}}}