Intervention Study: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence (TRAPist)

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 between 12.0 and 13.6 weeks in gestation 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, 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.

What is the purpose of this study?
The purpose of the study is to examine if early intervention improves the outcome of the pump twin as compared to late intervention.

Where is this study being conducted?
The University of Texas Health Science Center Houston is one of the sites in the United States taking part in this international clinical trial.

Who is the sponsor of the study?
The sponsor for the clinical trial is Professor Liesbeth Lewi at Universitaire Ziekenhuizen Leuven in Leuven, Belgium.

Why should I participate in this study?
Your participation may help determine the best therapeutic approach for pregnant women affected by TRAP.

What happens to me if I participate in the study?
If you decide to take part in the study you will be randomized to undergo fetal intervention either at 12-14 weeks gestational age (early) or 16-18 weeks gestational age (late). The investigators will review your ultrasounds, consults and will randomize via telemedicine.

Is compensation available for participation?
At this time there is no compensation for participation in the study.

Who can I contact for more information about this study?
Please contact The Fetal Center at (832) 325-7288 and ask for the Senior Research Scientist, Jeannine Garnett.