Why a randomized trial is necessary

There are two therapeutical approaches that appear to improve substantially the prognosis of such a severe condition. However, according to our present knowledge, both are potentially associated with complications, and therefore it is essential to know which of these treatments is better.

Present available data can not answer this question, because it is coming from different hospitals with different selection criteria, and therefore not comparable. It may be, for example, that the severity of the cases reported in one centre is different from another. Therefore, the only way to know which treatment is the best is to conduct a so-called "randomized trial", thus ensuring that the patients treated with one or another treatment have similar characteristics. This means that participating mothers have a 50% chance of getting either treatment. The treatment used is determined by a list made by a computer. At the end of the study, the results obtained will provide a real knowledge on the survival rates and complications associated to each treatment, and therefore will allow physicians to offer the best option to their patients.

Benefits of a TTTS randomized trial
The benefits of conducting this trial are clear,

  • TTTS is an extremely severe complication leading to fetal death or permanent neurologic damage for both twins in 60 to 100% of cases,
  • patients included in this study are managed with an option that in any case substantially improves the survival rate of their babies,
  • establishing which of the two treatments is the best in terms of survival rates and associated complications will be of great benefit for future mothers with this syndrome.

Why an open trial
The trial is a multicenter project because many cases are required. It is an open trial so any hospital in the world may join it by contacting with the organization.

Both health professionals and parents are encouraged to spread the knowledge of the syndrome, and raise the awareness of this Eurofoetus randomized trial to evaluate the best treatment for TTS. The more health centers incorporate, the time required for completion of the trial will decrease.