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WS07‐02Treatment for TTS should be done within a trial
Author(s) -
Ville Y.
Publication year - 2000
Publication title -
ultrasound in obstetrics and gynecology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.202
H-Index - 141
eISSN - 1469-0705
pISSN - 0960-7692
DOI - 10.1046/j.1469-0705.2000.00009-1-45.x
Subject(s) - medicine , randomized controlled trial , laser therapy , twin to twin transfusion syndrome , pace , pediatrics , pregnancy , surgery , fetus , laser , physics , biology , optics , genetics , geodesy , geography
Over a year I invited you here to participate to the rct for treating twin‐to‐twin transfusion syndrome (TTS). Are there any data available to reconsider this? The answer is clearly no, on the contrary. Indeed large series on amniodrainage or laser therapy have become available. With serial amniodrainage overall survival for both twins is 49% or 71% where at least one baby survive. In cases where one fetus dies in utero , 20% of the survivors die, and in another 20% they have severe neurological morbidity. Laser treatment has now a survival rate of 54% for both twins and 81% for at least one survivor. Neurological morbidity seems to be less than 10%. Has this larger experience contributed to solve the question whether one or the other therapy is better? No, it only underscores that our estimate of the number of patients needed in a rct was right: 10% difference in survival rate and 15% for severe neonatal morbidity. All new data, all new studies are an urgent call for randomisation. If not, both patients and their obstetricians will continue to argue based on unsubstantiated views. Further case series will not bring any critically new element. Results Over 45 patients have now been included, all but a few in France. If we would extrapolate the number of patients randomised at our centre, only three other groups would have to recruit at the same pace to reach the 142 patients needed by the end of next year. Discussion There are many arguments to try to finish the study within a few years. It avoids the obvious bias due to improvements of perinatal resuscitation. It would keep high motivation amongst referring clinicians. I would dare to say more: at this point it has become unethical not to randomise cases with TTTS. Not laser, neither amniodrainage have become established yet as the best treatment and there is no room for empirical new techniques until the trial is completed.