Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-29 @ 11:09 PM
Study NCT ID:
NCT01310660
Status:
COMPLETED
Last Update Posted:
2016-02-01
First Post:
2011-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Levator Injuries Using Transvaginal Endosonography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 269}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'lastUpdateSubmitDate': '2016-01-29', 'studyFirstSubmitDate': '2011-03-07', 'studyFirstSubmitQcDate': '2011-03-07', 'lastUpdatePostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The principal objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth.', 'timeFrame': 'Antenatal, after delivery and postnatal'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Childbirth Related Levator Injuries']}, 'descriptionModule': {'briefSummary': 'Prospective studies to date have identified that the levator ani muscle injuries occur in 14-19% of women after vaginal delivery.\n\nIn none of studies a vaginal examination was performed at the time of delivery. It has previously been shown that sonographic injuries of the anal sphincter that were believed to be occult were in fact clinically apparent but not recognised at the time of delivery. It is therefore important to correlate clinical findings to ultrasound images.\n\n3D endovaginal endosonography has not previously been used to identify levator injuries. This should potentially provide a better view of the pelvic floor muscles.\n\nThe relationship between levator injury and symptoms of pelvic floor dysfunction has not been previously established using validated questionnaires. In this study, we include validated questionnaires to evaluate urinary incontinence, faecal incontinence and vaginal symptoms. As symptoms may become apparent only in the long term it is prudent that the women are followed up in the long term.\n\nThe principle objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth. The levator muscle forms a major part of the pelvic floor and damage to this muscle can potentially cause urinary, bowel and sexual problems and pelvic organ prolapse.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nulliparous', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pregnant women who have not delivered previously\n2. Singleton pregnancy\n3. Maternal age \\> 18 years and\n4. No previous pregnancies \\>20 weeks of gestation\n5. Ability to read and understand English.\n\nExclusion Criteria:\n\n1. Pregnant women who have delivered previously\n2. Multiple pregnancies'}, 'identificationModule': {'nctId': 'NCT01310660', 'acronym': 'ELITE', 'briefTitle': 'Evaluation of Levator Injuries Using Transvaginal Endosonography', 'organization': {'class': 'OTHER', 'fullName': 'Croydon University Hospital'}, 'officialTitle': 'Evaluation of Levator Injuries Using Transvaginal Endosonography', 'orgStudyIdInfo': {'id': '10/H0806/87'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nulliparous'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CR7 7YE', 'city': 'Croydon', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Croydon University Hospital', 'geoPoint': {'lat': 51.38333, 'lon': -0.1}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Croydon University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Urogynaecologist', 'investigatorFullName': 'Ranee Thakar', 'investigatorAffiliation': 'Croydon University Hospital'}}}}