TRUFFLE-2 Study-Austria

Background and study aim: In the last months of pregnancy, babies who are smaller or who grow more slowly than expected are at higher risk of dying in the mother`s womb. Some of these smaller babies who survive may have developmental problems later in infancy. Doctors have many ways to monitor such babies in the womb but, until the baby is born, the only treatment available is to deliver the baby. If the pregnancy has reached its full term, induction of labor is the usual option. If the baby is preterm (before 37 weeks of pregnancy) the right course of action is less clear. Delivering the baby early, as soon as there are signs of problems, will minimize any damage due to lack of oxygen in the womb, but the baby may suffer harm because of being born prematurely. This study is looking at the balance of risks linked with continuing the pregnancy a little longer or delivering the baby early. Who can participate? Pregnant women whose babies are either smaller or growing more slowly than expected between 32 and 36 weeks of pregnancy, will be invited to participate in the study. What does the study involve? Babies will be closely monitored with ultrasound scans, Doppler tests for blood flow and computerized heart rate tests. All these tests are regularly used in normal maternity care and are safe. If the Doppler test shows changes in the blood flow to the babys brain, mothers will be randomly assigned to one of two groups: in one group the babies will be delivered immediately. In the other group the babies will continue to be monitored closely. Babies in the second group will be delivered if computerized analysis of the babys heart rate shows signs of deteriorating health. The health of all the babies will be recorded at birth, and their development checked at two years of age. What are the possible benefits and risks of participating? The timing of the babys birth will be chosen at random. The risks of being born too early are mainly of breathing problems for the baby and a very small risk of bleeding in the brain related to prematurity. The risks of waiting are that the babys condition may deteriorate rapidly such that he or she gets seriously short of oxygen. All these risks are very small. Neither ultrasound nor baby heart rate monitoring will cause harm to the baby directly. Where is the study run from? This international study is coordinated by Prof. Christoph Lees from the Imperial College London, UK. The Austrian part of the study will be coordinated by Prof. Philipp Klaritsch from the Medical University of Graz together with Dr. Julia Binder from the Medical University of Vienna and Dr. Samira Abdel-Azim from the Medical University of Innsbruck.