Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT04719533
Status:
UNKNOWN
Last Update Posted:
2021-10-21
First Post:
2020-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes Following Pre-marking of Episiotomy Location
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': "Patients' data recorded according to a coding system"}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomized-controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-13', 'studyFirstSubmitDate': '2020-10-02', 'studyFirstSubmitQcDate': '2021-01-20', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extended laceration of the episiotomy', 'timeFrame': 'Up to 1 hour following the episiotomy', 'description': 'Additional perineal tears originating from the original episiotomy, as described in the birth chart'}, {'measure': 'Third- and fourth-degree perineal tears', 'timeFrame': 'Up to 2 hours following the episiotomy', 'description': 'Perineal tears involving the anal sphincter in addition to the episiotomy, as documented in hospital records'}, {'measure': 'Post-partum hemorrhage', 'timeFrame': 'Up to 6 weeks following delivery', 'description': 'Early (\\<24 hours) or later (24 hours to 6 weeks) hemorrhage following delivery requiring physician intervention as documented in medical records'}, {'measure': 'Blood transfusion requirement', 'timeFrame': 'Up to 5 days following delivery', 'description': 'Any requirement for blood products following delivery as documented in the hospital discharge'}, {'measure': 'Episiotomy site infection', 'timeFrame': 'Up to 6 weeks following delivery', 'description': 'any documented infection of the episiotomy site treated in ambulatory or hospital setting, as recorded in medical records'}, {'measure': 'Requirement of resuturing of episiotomy or evacuation of hematoma', 'timeFrame': 'up to 6 weeks following delivery', 'description': 'Any additional surgical intervention required relating to the episiotomy, as recorded in medical records'}, {'measure': 'Long-term symptoms related to episiotomy', 'timeFrame': 'Up to 5 years following delivery', 'description': 'Any symptoms including perineal pain, dyspareunia, urine incontinence or fecal incontinence as reported by women using a numerical scale or dichotomic scale where appropriate'}, {'measure': 'Perineal tears in subsequent deliveries', 'timeFrame': 'Up to 5 years following delivery', 'description': 'As recorded in hospital records'}, {'measure': 'Surgical correction of episiotomy', 'timeFrame': 'Up to 5 years following delivery', 'description': 'Any additional surgical procedures required for correction of episiotomy related symptoms as recorded in medical records'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['episiotomy', 'episiotomy complications', 'premarked episiotomy'], 'conditions': ['Episiotomy; Complications', 'Episiotomy Extended by Laceration', 'Episiotomy Infection']}, 'descriptionModule': {'briefSummary': 'To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.', 'detailedDescription': 'Purpose: To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.\n\nHypothesis: Women following episiotomy following pre-marking of the location will suffer from fewer short- and long-term complications compared to those without pre-marked episiotomy location.\n\nStudy type: prospective randomized-controlled trial'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women 18 years of age or older who present in active labour to our center and consent to participate in the study\n\nExclusion Criteria:\n\n* women under 18 years of age or those who do not or are unable to provide informed consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT04719533', 'briefTitle': 'Outcomes Following Pre-marking of Episiotomy Location', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'Short and Long Term Outcomes of Patients With and Without Pre-marked Episiotomy Location', 'orgStudyIdInfo': {'id': 'SOR-0089-20-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-marked episiotomy location', 'description': 'Women in this group will undergo pre-marking of episiotomy location', 'interventionNames': ['Other: Pre-marking of episiotomy location']}, {'type': 'NO_INTERVENTION', 'label': 'No pre-marked episiotomy location', 'description': 'Women in this group will not undergo pre-marking of episiotomy location'}], 'interventions': [{'name': 'Pre-marking of episiotomy location', 'type': 'OTHER', 'description': 'A template marking the pre-determined correct location of episiotomy will be used to mark to women in the interventional group', 'armGroupLabels': ['Pre-marked episiotomy location']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84101', 'city': 'Beersheba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Sharon Davidesko, MD', 'role': 'CONTACT', 'email': 'shazadmoni85@gmail.com', 'phone': '+972546837362'}], 'facility': 'Soroka University Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'centralContacts': [{'name': 'Sharon Davidesko, MD', 'role': 'CONTACT', 'email': 'shazadmoni85@gmail.com', 'phone': '+972546837362'}], 'overallOfficials': [{'name': 'Sharon Davidesko, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data is to be shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sharon Davidesko MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sharon Davidesko MD', 'investigatorAffiliation': 'Soroka University Medical Center'}}}}