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TRAP Intervention STudy: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence
Sponsor: Universitaire Ziekenhuizen KU Leuven
Summary
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.
Official title: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence: an Open-label Randomized Controlled Trial: TRAPIST - TRAP Intervention STudy
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2016-05
Completion Date
2025-06
Last Updated
2024-07-10
Healthy Volunteers
No
Interventions
Early selective reduction of TRAP mass
Ultrasound-guided intrafetal ablation using an 18 Gauge to 20 Gauge needle
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.
Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle
Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle
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
Locations (14)
Children's Memorial Hermann Hospital
Houston, Texas, United States
Universitätsklinik für Frauenheilkunde und Geburtshilfe
Graz, Austria
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Mount Sinai Hospital
Toronto, Canada
Centre Médico-Chirurgical et Obstétrical
Schiltigheim, France
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Sheba Medical Center
Tel Litwinsky, Israel
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy
Ospedale dei Bambini Vittore Buzzi
Milan, Italy
Leiden University Medical Center
Leiden, Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Birmingham Women's Hospital
Birmingham, United Kingdom
King's College
London, United Kingdom
St. George's Hospital, University of London (UK sponsor)
London, United Kingdom