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Early selective reduction of TRAP mass.",[13,14],"Procedure: Early selective reduction of TRAP mass","Device: Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle",{"label":16,"type":17,"description":18,"interventionNames":19},"Late intervention","ACTIVE_COMPARATOR","Intervention between 16.0 and 19.0 weeks. Late selective reduction of TRAP mass. This is the standard timing of the intervention. One of two possible techniques for late reduction is chosen by the treating physician.",[20,21,22],"Procedure: Late selective reduction of TRAP mass","Device: Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle","Device: Laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber",[24,30,34,38,41],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"PROCEDURE","Early selective reduction of TRAP mass","Ultrasound-guided intrafetal ablation using an 18 Gauge to 20 Gauge needle",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Late selective reduction of TRAP mass","Ultrasound-guided intrafetal ablation using a 17 Gauge to 20 Gauge needle OR fetoscopic laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber. The treating physician can decide which technique will be used for the selective reduction.",[16],{"type":35,"name":36,"description":29,"armGroupLabels":37,"otherNames":29},"DEVICE","Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle",[9],{"type":35,"name":39,"description":29,"armGroupLabels":40,"otherNames":29},"Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle",[16],{"type":35,"name":42,"description":29,"armGroupLabels":43,"otherNames":29},"Laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber",[16],[45],{"name":46,"affiliation":47,"role":48},"Liesbeth Lewi, MD PhD","UZ Leuven","STUDY_CHAIR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":29,"email":54},"Isabel Couck, MD","CONTACT","+32 16 342294","isabel.couck@uzleuven.be",{"name":46,"role":52,"phone":56,"phoneExt":29,"email":57},"+32 16 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Davies",{"type":241,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[243,245,246,248,250,252,254,256,258,260,262,263,265,267,269],{"name":231,"class":244},"UNKNOWN",{"name":179,"class":6},{"name":247,"class":244},"Ospedalo Maggiore Policlinico di Milano, Italy",{"name":249,"class":244},"Hospital Universitari Vall d'hebron Barcelona, Spain",{"name":251,"class":244},"Centro Médico-Chirurgical et Obstétrical (CMCO) Schiltigheim, France",{"name":253,"class":244},"Universitätsklinik für Frauenheilkunde und Geburtshilfe Graz, Austria",{"name":255,"class":244},"Ospedale dei Bambini \"Vittore Buzzi\" Milano, Italy",{"name":257,"class":244},"Birmingham Women's Hospital, UK",{"name":145,"class":259},"OTHER_GOV",{"name":261,"class":244},"Children's Memorial Hermann Hospital Houston Texas, USA",{"name":132,"class":6},{"name":264,"class":6},"Mount Sinai Hospital, Canada",{"name":266,"class":6},"University of Pittsburgh",{"name":268,"class":244},"University Hospital Innsbruck, Austria",{"name":270,"class":244},"Spedali Civili, University of Brescia, Italy","100256780","phase-4-trap-intervention-study-early-versus-late-intervention-for-twin-reversed-arterial-perfusion-sequence-100256780",false,"NCT02621645","TRAP Intervention STudy: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence","Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence: an Open-label Randomized Controlled Trial: TRAPIST - TRAP Intervention STudy","TRAPIST","Inclusion Criteria:\n\n* TRAP sequence in a monochorionic diamniotic twin pregnancy diagnosed between 11.6 and 13.6 weeks, as determined by the crown-rump length of the pump twin in spontaneous conceptions and by the date of insemination or embryonic age at replacement in pregnancies resulting from subfertility treatment\n* Women aged 18 years or more, who are able to consent\n* Anatomically normal pump twin\n* Provide written informed consent to participate in this randomized controlled trial, forms being approved by the Ethical Committees\n\nExclusion Criteria:\n\n* Contraindication for an intervention due to a severe maternal medical condition or threatening miscarriage\n* Inaccessibility of the acardiac twin due to a retroverted uterus, severe maternal obesity, uterine fibroids, bowel or placental superposition\n* A major anomaly in the pump twin, requiring surgery or leading to infant death or severe handicap\n* Spontaneous arrest of the reverse flow and\u002For pump twin demise at diagnosis","FEMALE","18 Years",{"count":282,"type":283},126,"ESTIMATED","INTERVENTIONAL",[286],"PHASE4","Multi-center open-label randomized controlled trial to assess if early intervention (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late intervention (16.0-19.0 weeks) (control group). The investigators will randomly assign women diagnosed with TRAP sequence diagnosed between 12.0 and 13.6 weeks to an early or late intervention group (1:1), using a web-based application and a computer-generated list with random permuted blocks of sizes 2 or 4 (www.sealedenvelope.com), stratified by gestational age (GA) at inclusion (11.6 -12.6 weeks versus 13.0-13.6 weeks). Analysis will be by intention to treat.",[289],"Twin Reversal Arterial Perfusion Syndrome",[291,292,293],"monochorionic","TRAP","acardiac twin","2024-07-09",{"date":296,"type":297},"2024-07-10","ACTUAL",{"date":299,"type":297},"2016-05",{"date":301,"type":283},"2025-06",{"name":5,"class":6},14]