Why do we need this research?
Thrombophilia is a condition that increases a person’s chances of having a blood clot. Pregnant women with inherited thrombophilia are thought to be more likely to experience complications during their pregnancy, such as pre-eclampsia, slow growth and recurrent miscarriage.
Anticoagulants – or ‘blood-thinning’ medicines – are the main treatment for people with thrombophilia. Many clinicians believe that anticoagulant treatments could improve outcomes for women with inherited thrombophilia who have experienced multiple miscarriages, although the current evidence for their use is inconclusive. More research is needed to show whether this treatment really does help to prevent miscarriage.
What’s happening in this project?
Researchers funded by Tommy’s are taking part in a large, multinational study called ALIFE-2. In this randomised controlled trial, women with inherited thrombophilia and a history of at least two previous losses will either be treated with Low Molecular Weight Heparin (LMWH) or receive standard pregnancy monitoring only. LMWH treatment will begin within the first seven weeks of pregnancy and continue until birth.
The ALIFE-2 study is being carried out at 40 hospitals in eight countries around the world. 400 women agreed to take part, and 327 became pregnant and have been allocated to either treatment with LMWH or standard care. The team are waiting for the last few women to deliver their babies, and then will assess whether treatment with LMWH was beneficial by comparing how many women in each group had a live birth. They will also check how many women had pregnancy complications such as miscarriage, pre-eclampsia and premature birth, and make sure that there were no safety concerns with LMWH treatment.
What difference will this project make?
This study should finally confirm whether anticoagulant treatment can help to prevent further losses in women with inherited thrombophilia and a history of recurrent miscarriage. If the trial is successful, LMWH could become the standard treatment for these women. However, this study may also show that LMWH treatment does not improve outcomes for these women. If this happens, it will mean that women with inherited thrombophilia and a history of recurrent miscarriage no longer need to receive unnecessary anticoagulant treatment during their pregnancies, and researchers will be able to focus their attention on other promising treatments for these women.