[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584307":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":43,"responsibleParty":62,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":23,"enrollmentInfo":77,"targetDuration":23,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":91,"whyStopped":23,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of Milano Bicocca","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Rebozo and Maternal Procedures","ACTIVE_COMPARATOR","Combination of forward-leaning inversion (FLI) and side-lying release (SLR) and Rebozo technique in a pre-specified order (see Assigned Interventions).",[13],"Other: Rebozo and Maternal Procedures",{"label":15,"type":10,"description":16,"interventionNames":17},"Control group","Standard of care, including upright, semi-recumbent, lateral recumbent, and hands-and-knees position.",[18],"Other: Control",[20,24],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"Combination of FLI and side-lying release SLR and Rebozo technique in a pre-specified order:\n\n1\\) FLI for 30 seconds repeated for 3 subconsequent contractions; 2) SLR for 30 seconds repeated for 3 consequent contractions; 3) Rest with free maternal postures for 15 minutes; 4) 15 minutes of Rebozo on maternal pelvis (women on hands and knees); 5) Rest with free maternal postures for 15 minutes; 6) 15 minutes of Rebozo on the side of the fetal spine (supine women).\n\nDuration of the intervention ranges between 90 and 105 minutes. The intervention will start within thirty minutes after randomization; it can be interrupted at any time if needed. It will be considered performed when the proposed sequence is completed. After completion of the sequence, women will be allowed to move freely and adopt different postures. No FLI or SLR procedures or the Rebozo technique will be further allowed until sonographic assessment of the fetal head is performed at 3 hour and thirty after randomization",[9],null,{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Control","Standard of care, including upright, semi-recumbent, lateral recumbent, and hands-and-knees position. They will not receive forward-leaning inversion (FLI) and side-lying release (SLR) and Rebozo technique. the control group will continue to adopt maternal postures with no possibility of performing the FLI or SLR procedures or the Rebozo technique until sonographic assessment of fetal head position is completed at 3 hours and thirty after randomization.",[15],[29],{"name":30,"affiliation":31,"role":32},"Sara Ornaghi, PHD","School of Medicine and Surgery, University of Milano-Bicocca, 20900 Monza, Italy","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":23,"email":38},"Maria Panzeri, PHD student","CONTACT","00393337422526","maria.panzeri@unimib.it",{"name":40,"role":36,"phone":41,"phoneExt":23,"email":42},"Simona Fumagalli, PHD","00393935554696","simona.fumagalli@unimib.it",[44],{"facility":45,"status":23,"city":46,"state":23,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"IRCCS San Gerardo dei Tintori","Monza","20900","Italy","IT",{"type":51,"coordinates":52},"Point",[53,54],9.27246,45.58005,{"lat":54,"lon":53},[57,61],{"name":58,"role":36,"phone":59,"phoneExt":23,"email":60},"Sara Ornaghi","00393381693586","sara.ornaghi@unimib.it",{"name":58,"role":32,"phone":23,"phoneExt":23,"email":23},{"type":63,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[65],{"name":66,"class":6},"Fondazione IRCCS San Gerardo dei Tintori","100584307","rebozo-and-maternal-procedures-to-reduce-persistent-occiput-posterior-position-of-the-fetal-head-100584307",false,"NCT06887634","Rebozo and Maternal Procedures to Reduce Persistent Occiput Posterior Position of the Fetal Head","Rebozo and Maternal Procedures to Reduce Persistent Occiput Posterior Position of the Fetal Head: a Randomized Clinical Trial - the ReMaP-POPP RCT -","ReMaP-POPP","Inclusion Criteria:\n\n* woman in labor between 3 and 8 cm of cervical dilation\n* woman with a singleton term fetus (≥37 0\u002F7 weeks of gestation) in an Occiput Posterior Persistent Position clinically diagnosed and confirmed by transabdominal sonography\n\nExclusion Criteria:\n\n* Women with growth restricted fetuses according to the Delphi's consensus\n* Fetuses with congenital anomalies or infections or with chromosomal abnormalities\n* Intrauterine fetal demise\n* Fetal and\u002For maternal conditions requiring urgent or emergent delivery or impeding the use of FLI and SLR and\u002For the Rebozo technique (non-reassuring fetal heart rate, abnormal vaginal bleeding, immobilizing epidural analgesia, polyhydramnios, extrapelvic fetal head, body mass index ≥35 Kg\u002Fm2, hypertensive disorders of pregnancy with inadequate control of blood pressure, maternal heart disease in class III to V according to the modified World Health Organization, glaucoma or ocular surgery, esophageal reflux disease, hypermobile sacro-ileac joint, and severe symphysis dysfunction)","FEMALE","18 Years",{"count":78,"type":79},578,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this clinical trial is to assess whether a combination of forward-leaning inversion and side-lying release procedures and Rebozo technique in a pre-specified sequence during the first stage of labor among women with a posterior fetus would favor anterior rotation. The main questions it aims to answer is:\n\n• What is the probability of persistent occiput posterior position of the fetal head three hours and thirty minutes after randomization, diagnosed by sonography? Researchers will compare the intervention group, which received a sequence of forward-leaning inversion (FLI), side-lying release procedures (SLR), and the Rebozo technique (lasting 90-105 minutes), to the control group, which received standard care (free maternal postures), to assess whether the specific combination of interventions in the experimental group reduces the probability of the fetal head remaining in the occiput posterior position.\n\nParticipants in the intervention group will undergo a combination of forward-leaning inversion, side-lying release procedures, and the Rebozo technique, administered in a pre-determined sequence. In contrast, participants in the control group will receive standard care (free maternal postures).",[85],"Persistent Occiput Posterior Position During Labor",[87,88,89,90],"Occiput posterior position","Persistent Occiput Posterior Position","Rebozo technic","Maternal postures","NOT_YET_RECRUITING","2025-08-29",{"date":94,"type":95},"2025-09-05","ACTUAL",{"date":97,"type":79},"2025-09",{"date":99,"type":79},"2027-07",{"name":5,"class":6},1]