Condition: Twin Reversal Arterial Perfusion Syndrome · Sponsor: Universitaire Ziekenhuizen KU Leuven
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.
This description comes directly from the study's public registry record.
Isabel Couck, MD · +32 16 342294 · isabel.couck@uzleuven.be
Liesbeth Lewi, MD PhD · +32 16 342862 · liesbeth.lewi@uzleuven.be
Always discuss trial participation with your own doctor first.
| Children's Memorial Hermann Hospital | Houston, Texas, United States | Recruiting |
| Universitätsklinik für Frauenheilkunde und Geburtshilfe | Graz, Austria | Recruiting |
| Universitaire Ziekenhuizen Leuven | Leuven, Belgium | Recruiting |
| Mount Sinai Hospital | Toronto, Canada | Recruiting |
| Centre Médico-Chirurgical et Obstétrical | Schiltigheim, France | Recruiting |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg, Germany | Recruiting |
| Sheba Medical Center | Tel Litwinsky, Israel | Recruiting |
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Milan, Italy | Recruiting |
| Ospedale dei Bambini Vittore Buzzi | Milan, Italy | Recruiting |
| Leiden University Medical Center | Leiden, Netherlands | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona, Spain | Recruiting |
| Birmingham Women's Hospital | Birmingham, United Kingdom | Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT02621645