Ignite Creation Date:
2025-12-24 @ 3:39 PM
Ignite Modification Date:
2026-01-01 @ 9:53 PM
Study NCT ID:
NCT00799292
Status:
COMPLETED
Last Update Posted:
2018-07-24
First Post:
2008-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014667', 'term': 'Vasopressins'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'charles.ascher-walsh@mssm.edu', 'phone': '212-241-2827', 'title': 'Charles Ascher-Walsh MD, MPH', 'organization': 'Mt Sinai School of Medicine, Department of Obstetrics and Gynecology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intra-operative Blood Loss During Vaginal Hysterectomy', 'timeFrame': 'Blood loss will be assessed at the end of the operative procedure', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Operative Time and Complication Rates', 'timeFrame': 'Duration of procedures and immediate post-operative stay in hospital', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Estimated Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Injection', 'description': 'Patients did not receive an injection at cervix prior to beginning the procedure.'}, {'id': 'OG001', 'title': 'Injection of Vasopressin', 'description': 'Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.'}], 'classes': [{'categories': [{'measurements': [{'value': '266.4', 'spread': '240.50', 'groupId': 'OG000'}, {'value': '145.3', 'spread': '137.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of vaginal hysterectomy', 'description': 'Estimated blood loss as mL', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Injection', 'description': 'Patients did not receive an injection at cervix prior to beginning the procedure.'}, {'id': 'FG001', 'title': 'Injection of Vasopressin', 'description': 'Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Enrollment and informed consent was obtained prior to the operation in the gynecology clinic or private offices from 1/2004 - 1/2005.', 'preAssignmentDetails': 'Randomization occurred at the time of surgery.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No Injection', 'description': 'Patients did not receive an injection at cervix prior to beginning the procedure.'}, {'id': 'BG001', 'title': 'Injection of Vasopressin', 'description': 'Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-25', 'studyFirstSubmitDate': '2008-10-21', 'resultsFirstSubmitDate': '2008-10-21', 'studyFirstSubmitQcDate': '2008-11-26', 'lastUpdatePostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2008-11-26', 'studyFirstPostDateStruct': {'date': '2008-11-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2008-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra-operative Blood Loss During Vaginal Hysterectomy', 'timeFrame': 'Blood loss will be assessed at the end of the operative procedure'}, {'measure': 'Estimated Blood Loss', 'timeFrame': 'Duration of vaginal hysterectomy', 'description': 'Estimated blood loss as mL'}], 'secondaryOutcomes': [{'measure': 'Operative Time and Complication Rates', 'timeFrame': 'Duration of procedures and immediate post-operative stay in hospital'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Blood Loss During Vaginal Hysterectomy']}, 'referencesModule': {'references': [{'pmid': '19155900', 'type': 'DERIVED', 'citation': 'Ascher-Walsh CJ, Capes T, Smith J, Michels A. Cervical vasopressin compared with no premedication and blood loss during vaginal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2009 Feb;113(2 Pt 1):313-8. doi: 10.1097/AOG.0b013e3181954c44.'}]}, 'descriptionModule': {'briefSummary': 'Vasoconstrictive agents are increasingly being used in order to decrease blood loss during vaginal hysterectomy. The first reported study of the use of a vasoconstrictive agent for this purpose was on the use of epinephrine injected intracervically preoperatively by England, et. al. They demonstrated a significant decrease in the amount of blood lost during the surgery but also demonstrated a significant increase in the risk of post-operative infections, most frequently a vaginal cuff cellulitis requiring antibiotic treatment. Recent studies using vasopressin as the vasoconstrictive agent have also found the same significant decrease in blood loss while not demonstrating a difference in the rate of post-operative infections. The more recent studies by Speer and Unger , and Kammerer-Doak, et.al. were larger, better designed studies and are considered more credible. More surgeons are therefore injecting vasopressin intracervically preoperatively.\n\nSome surgeons believe that the injection of vasopressin intracervically prior to the initial incision of a vaginal hysterectomy effects surgical plains and therefore makes the surgical dissection more difficult. This is thought to possibly both add to operative time and increase the rate of complications. The aforementioned studies used the injection of saline as a control for the injection of vasopressin or epinephrine. To date, no study has compared the use of vasopressin versus no injection in a controlled, randomized manner. We do not know if the injection of saline intracervically may actually increase the amount of bleeding over the baseline and therefore the decreased blood loss caused by the injection of vasopressin my actually be overestimated.\n\nWe propose to compare the effects of injecting vasopressin intracervically preoperatively versus no preoperative medication. We will not only evaluate the amount of operative blood loss, but also compare operative time and complication rates.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women greater that 18 undergoing vaginal hysterectomy for any indication, with or without concomitant procedures\n\nExclusion Criteria:\n\n* women with a significant medical condition, including severe liver disease, congestive heart failure, documented coronary artery disease, impaired renal function determined by an elevated serum creatinine, asthma with steroid use in the past year, and migraines'}, 'identificationModule': {'nctId': 'NCT00799292', 'briefTitle': 'Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial', 'organization': {'class': 'INDIV', 'fullName': 'Ascher-Walsh, Charles, M.D.'}, 'officialTitle': 'Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy', 'orgStudyIdInfo': {'id': 'ASW 123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No injection', 'description': 'Patients did not receive an injection at cervix prior to beginning the procedure'}, {'type': 'EXPERIMENTAL', 'label': 'Injection of vasopressin', 'description': 'Patients will be randomized to receive 20cc of dilute vasopressin (20units in 50cc normal saline)injected at cervix at beginning of the hysterectomy', 'interventionNames': ['Drug: Vasopressin']}], 'interventions': [{'name': 'Vasopressin', 'type': 'DRUG', 'description': "20cc of dilute vasopressin (20units in 50cc normal saline). At beginning of the procedure 5cc injected were injected at 2,4,8 and 10 o'clock on the cervix", 'armGroupLabels': ['Injection of vasopressin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Charles Ascher-Walsh, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mt Sinai School of Medicine, Dept Obstetrics and Gynecology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascher-Walsh, Charles, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'oldNameTitle': 'Charles Ascher-Walsh MD, MPH', 'oldOrganization': 'Mt Sinai School of Medicine, Department of Obstetrics and Gynecology'}}}}