[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"obstetric-trauma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:obstetric-trauma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,58],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100480030","correlation-pelvic-floor-function-and-ultrasound-findings-one-year-after-childbirth-100480030",false,"NCT05530681","Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth","DeliverUU","Inclusion Criteria:\n\n* age = or \\> 18 years\n* Dutch\u002FEnglish-speaking\n* \\> 33 weeks gestation\n* delivering in UZ Leuven\n* vaginal delivery\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* not Dutch\u002FEnglish-speaking\n* \\\u003C 33 weeks gestation\n* not delivering in UZ Leuven\n* non-vaginal delivery\n* Any disorder, that independently from delivery, affects pelvic floor function or structure, such as, but not limited to musculoskeletal or neurologic diseases.\n* any women with drug addiction, cognitive deficit, language-barrier and illiteracy\n* any disorder or timing or circumstances, which in the Investigator's opinion represents an obstacle to proper informed consent, or safe and\u002For compliant participation.\n* any prior or simultaneous treatment(s) potentially jeopardising safety or compromising trial integrity.","FEMALE","18 Years","45 Years",{"count":20,"type":21},320,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a single-center prospective cohort study sponsored by the University Hospitals Leuven (UZ). Women will undergo a pelvic floor ultrasound and will be asked to fill out a questionnaire at the time of their admission into the labour suite, at the postpartum check-up and 12 months postpartum.\n\nThe primary objective is to correlate self-reported symptoms of Pelvic Floor Dysfunction (PFD) (binary outcome) at one year after delivery with structural changes to the Pelvic Floor Muscles (PFM) and postpartum evidence of levator avulsion (binary indicator) as measured by TransPerineal UltraSound (TPUS).\n\nSecondary objectives are to compare demographical and obstetrical variables between patients suffering from PFD symptoms or pelvic floor injury (documented one year after delivery) and those who do not; to record how patients manage and cope with PFD including recovery and compliance with Pelvic Floor Muscle Training (PFMT) as prescribed in the standard pathway of peripartum care; and to use of TPUS images for the development of artificial intelligence tools for automated image analysis.\n\nPrimary outcomes are PFD symptoms one year after delivery and injury to the PFM evidenced by POP-Q and TPUS. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records.\n\nThe presence and severity of PFD will be measured using standardized self-reporting tools: Pelvic Organ Prolapse Distress Index (POP-DI), Patient Assessment Constipation-SYMptoms (PAC-SYM), International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-SF), St. Mark's Incontinence Score (SMIS), Female Sexual Function Index (FSFI), Female Sexual Distress Scale - Revised (FSDS-R). FSFI is a widely used generic tool with sufficient granularity and validated in a large number of languages. FSDS-R assesses the construct \"personal distress\", which has been considered as an additional important aspect contributing to sexual dysfunction of women.\n\nPFD, as a clustered outcome, being the presence of any kind of pelvic floor dysfunction symptoms, will be defined as POP-DI score of ≥11 OR ICIQ-SF score of ≥1 OR SMIS score of ≥1 OR FSFI score ≤ 26.55 OR FSDS-R score ≥11.",[27,28,29,30,31,32,33,34,35],"Pelvic Floor Disorders","Obstetric Trauma","Urinary Incontinence","Anal Incontinence","Pelvic Organ Prolapse","Pelvic Pain","Sexual Dysfunction","Constipation","Anal Sphincter Injury",[37,38,39,40,41,42,43,44],"urinary incontinence","anal incontinence","pelvic organ prolapse","sexual dysfunction","constipation","postpartum","levator avulsion","anal sphincter injury","RECRUITING","2024-06-28",{"date":48,"type":49},"2024-07-01","ACTUAL",{"date":51,"type":49},"2022-08-17",{"date":53,"type":21},"2025-09-01",{"name":55,"class":56},"Universitaire Ziekenhuizen KU Leuven","OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":57},"100519917","prelabor-visual-biofeedback-by-a-self-operated-ultrasound-device-100519917","NCT06049784","Prelabor Visual Biofeedback by a Self-operated Ultrasound Device","Prelabor Maternal Pushing Training Using Visual Biofeedback by a Self-operated Ultrasound Device","Inclusion Criteria:\n\n* Nuliparity\n* Singleton pregnancy\n* Planned for vaginal delivery\n* Low risk pregnancy\n* Ability to fulfill a questionnaire\n\nExclusion Criteria:\n\n* Multifetal gestation\n* Contraindications for vaginal delivery (Placenta previa, Breech presentation etc.)\n* High risk pregnancy",true,{"count":67,"type":21},261,[24],"A substantial number of women report fear of childbirth and negative birth experiences. The objective of the study is to assess the efficacy of visual biofeedback before labor using a self-operated home ultrasound for maternal pushing training, which is expected to reduce fear of childbirth, increase perceived control during birth, prevent prolonged labor and the ensuing maternal and neonatal negative adverse outcomes, and prevent maternal post-traumatic stress symptoms. Intrapartum visual biofeedback provided by obstetricians during the second stage of labor has been shown to increase pushing efficiency and improve maternal obstetric and psychological outcomes. Previously, visual biofeedback has been implemented only in an in-hospital setting and, with one known exception, only during labor. A Mobile Self-Operated Home Ultrasound System has been reported as a feasible and reliable tool for obstetrical ultrasound. A randomized controlled trial will be conducted with three study groups of pregnant women (37-39 weeks of gestation): (1) Obstetrical ultrasound+visual biofeedback in-hospital and at home using self-operated ultrasound; (2) Obstetrical ultrasound+visual biofeedback in-hospital; (3) Obstetrical ultrasound only. Visual biofeedback by ultrasound will be performed by transperineal ultrasound, enabling the future mother to visualize the descent of the fetal head within the birth canal in response to her pushing effort. Follow-up will be conducted two weeks later and at six weeks postpartum. Positive results following the application of biofeedback by self-operated home ultrasound may change the paradigm for pre-labour sonographic education. Self-operated home ultrasound will also enable more comprehensive pre-labor ultrasound-based education and hopefully reduce adverse physical and psychological outcomes following childbirth.",[71,28],"Obstetric Labor Complications",[73,74,75,76],"Visual Biofeedback","Self Operated Ultrasound device","Second stage of labor","Trans Perineal Ultrasound","2024-05-02",{"date":79,"type":49},"2024-05-06",{"date":81,"type":49},"2023-12-31",{"date":83,"type":21},"2026-12",{"name":85,"class":56},"Rabin Medical Center"]