Randomized Trial for Stage 1 Twin-To-Twin Transfusion Syndrome

In this study, women who are pregnant with identical twins with stage I twin-to-twin transfusion syndrome (TTTS) will be randomly assigned to one of two groups: an early surgical intervention group or an observational group, whereby surgical intervention is offered only if and when the condition progresses to stages II to IV.

Our program is the first in North American to enroll patients in this multicenter, international study. A detailed description of the study is available here: http://clinicaltrials.gov/ct2/show/NCT01220011?term=stage+i+twin&rank=1

Rationale

Stage 1 TTTS can improve spontaneously, therefore fetal surgery (fetoscopic ablation of placental vessels) has historically been reserved for more severe stages (stages II, III and IV). We are not able to predict with certainty which patients will worsen and which will improve. This study will help us to determine whether it’s beneficial and worth the risk of intervening early so as to prevent the condition from progressing, or whether it’s better to intervene in the later stages of TTTS when it’s obvious that treatment is necessary.