A randomised placebo-controlled trial of low-dose aspirin initiated in the first trimester for optimising pregnancy outcome in pregestational diabetes

Pre-existing diabetes confers a high risk for adverse pregnancy outcome. High blood pressure disorders in pregnancy, including preeclampsia, are particularly common in this population and the combination of pre-existing diabetes and preeclampsia represents a notable high risk for poor pregnancy outcome, including stillbirth. Preeclampsia is known to originate in early pregnancy, at the time of early placental development, although it does not manifest until much later in pregnancy.

The role of aspirin in the prevention of preeclampsia has been investigated in several trials. Some early trials demonstrated an impressive benefit, while later larger trials did not. Pooled data from these studies suggest that there may be a modest benefit to aspirin therapy in some women deemed to be at high risk for developing preeclampsia. However, the few studies that recruited women with diabetes report conflicting results. Furthermore, the majority of such studies initiated aspirin therapy too late in pregnancy for it to plausibly exert any beneficial effect, because the placenta is effectively built in the first 14 weeks of pregnancy, during which time the fate of late pregnancy outcome is determined.

The aim of this study is to ascertain whether aspirin therapy commenced in early pregnancy in women with pre-existing diabetes may reduce the risk of poor pregnancy outcome related to placental dysfunction in this high-risk obstetric population.


Award Date
24 February 2017
Award Value
€776,996
Principal Investigator
Professor Fionnuala Breathnach
Host Institution
Royal College of Surgeons in Ireland
Scheme
Definitive Intervention and Feasibility Awards