[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519917":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":34,"centralContacts":41,"locations":50,"responsibleParty":68,"collaborators":71,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":24,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":24,"enrollmentInfo":84,"targetDuration":24,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":52,"whyStopped":24,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Rabin Medical Center","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Visual Biofeedback using self operated home ultrasound device","EXPERIMENTAL","Sonographic fetal weight and biophysical profiles will be done at the hospital clinic. A single ultrasound biofeedback session using trans-perineal Ultrasound (TPU) will guide maternal pushing. The process includes (a) Ultrasound assessing fetal head descent with the screen facing the provider, measuring the angle of progression (AOP); (b) Explaining anatomical landmarks to the patient; (c) Repeat AOP measurement with the screen facing the patient for biofeedback; (d) Reassess with the screen turned away.\n\nParticipants will receive a handheld home ultrasound device, learning to perform self-biofeedback at home, ideally twice a week, up to 4 times. Session records will be sent electronically to the sonographer for assessment and feedback.\n\nAll groups will complete questionnaires three times: (1) baseline, (2) about two weeks later (after home biofeedback training), and (3) six to eight weeks postpartum.",[13],"Device: Visual Biofeedback using self operated home ultrasound device",{"label":15,"type":16,"description":17,"interventionNames":18},"Visual biofeedback at the Hospital","ACTIVE_COMPARATOR","A sonographic fetal weight estimate and biophysical profile will occur at the hospital clinic for all patients. A single ultrasound-based biofeedback session will employ TPU for maternal pushing guidance. This process involves (a) Assessing fetal head descent with ultrasound to measure the angle of progression (AOP) during rest and pushing; (b) Explaining anatomical landmarks to the patient; (c) Repeating the AOP measurement as biofeedback; (d) Reassessing with the screen turned away.\n\nParticipants will complete questionnaires three times: (1) baseline, (2) two weeks later, and (3) six to eight weeks postpartum.",[19],"Device: Visual Biofeedback using ultrasound at hospital",{"label":21,"type":22,"description":23,"interventionNames":24},"Control \u002F Standard care - Obstetrical ultrasound only","NO_INTERVENTION","A sonographic estimated fetal weight and biophysical profile will be performed in the hospital.\n\nThe participant will fill in questionnaires at three time points: (1) at baseline, before the ultrasound examination; (2) about two weeks later (i.e., after completing the self-operated visual biofeedback training at home, or at an equivalent time for the other two groups); (3) six to eight weeks postpartum.",null,[26,30],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":24},"DEVICE","participants will receive a handheld home ultrasound device, learning to perform self-biofeedback at home. Session records will be sent electronically to the sonographer for assessment and feedback.",[9],{"type":27,"name":31,"description":32,"armGroupLabels":33,"otherNames":24},"Visual Biofeedback using ultrasound at hospital","A single ultrasound biofeedback session using Transperineal Ultrasound will guide maternal pushing.",[15],[35,39],{"name":36,"affiliation":37,"role":38},"Sharon Perlman, MD","Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":37,"role":38},"Natav Hendin, MD",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":24,"email":46},"Shira Waks","CONTACT","972528557212","Shiraw@clalit.org.il",{"name":36,"role":44,"phone":48,"phoneExt":24,"email":49},"972547481097","drsharonperlman@gmail.com",[51],{"facility":5,"status":52,"city":53,"state":24,"zip":24,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Petah Tikva","Israel","IL",{"type":57,"coordinates":58},"Point",[59,60],34.88747,32.08707,{"lat":60,"lon":59},[63,65],{"name":64,"role":44,"phone":48,"phoneExt":24,"email":49},"Sharon Perlman, Prof",{"name":40,"role":44,"phone":66,"phoneExt":24,"email":67},"972546899506","Hendinatav@gmail.com",{"type":38,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Sharon Perlman","Senior attending physician, Proffesor of Obstetrics and Gynecology",[72],{"name":73,"class":6},"Tel Aviv University","100519917","prelabor-visual-biofeedback-by-a-self-operated-ultrasound-device-100519917",false,"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,"FEMALE","18 Years",{"count":85,"type":86},261,"ESTIMATED","INTERVENTIONAL",[89],"NA","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.",[92,93],"Obstetric Labor Complications","Obstetric Trauma",[95,96,97,98],"Visual Biofeedback","Self Operated Ultrasound device","Second stage of labor","Trans Perineal Ultrasound","2024-05-02",{"date":101,"type":102},"2024-05-06","ACTUAL",{"date":104,"type":102},"2023-12-31",{"date":106,"type":86},"2026-12",{"name":5,"class":6},1]