Rotunda Hospital researchers awarded €1.4 million to help avoid life-threatening pregnancy complications

Researchers from the Rotunda Hospital and the HRB Mother and Baby Clinical Trial Network have been granted funding from the Health Research Board for two new clinical trials that aim to improve the health outcomes of pregnant women with diabetes and to prevent life-threatening blood clots.

The IRELAnD trial will study the role of aspirin in improving the health of pregnant women with diabetes. Women who have diabetes before they become pregnant are among the highest risk patients in obstetrics. Such women have a very significant risk of developing a high blood pressure complication of pregnancy, called preeclampsia. Low-dose aspirin has been investigated for the prevention of preeclampsia, with mixed results, but such prior studies  have not focussed on women with diabetes specifically. The IRELAnD trial aims to reduce the incidence of preeclampsia in this this at-risk population and will recruit over 550 women across 8 sites in Ireland over 3 years.

Professor Fionnuala Breathnach, Consultant in Obstetrics and Gynaecology, RCSI and Rotunda Hospital, the lead investigator for IRELAnD said

‘Our research team is highly motivated to embark on this important work. There exists a growing population of women entering into pregnancy with a diagnosis of pre-existing diabetes, and a disproportionate degree of poor pregnancy outcome is shouldered by this high-risk group of women. The capacity of aspirin to reduce the incidence of pregnancy-related high blood pressure and its complications, to prolong gestation, to increase birth weight and to reduce the unacceptably high incidence of stillbirth in this population would confer life-long health benefits to the children of women with diabetes.’

In the HIGHLOW study, doctors in Ireland and in other countries will collaborate to perform a large study comparing different doses of medication to prevent recurrence of life-threatening blood clots in pregnant women. The study will determine which dose is most effective (in terms of preventing a new blood clot) and safest (in terms of side-effects such as bleeding). Women who are pregnant have an increased chance of developing blood clots, and women with a previous blood clot have a higher recurrence risk in pregnancy. In fact, the risk is so high that clot-preventing medication (Low Molecular Weight Heparin) is warranted during the entire pregnancy and for 6 weeks after delivery in select patients. However, although the stakes are so high, we simply do not know what the correct medication dose is for these patients because this critically important question has not been adequately answered previously. The HIGHLOW trial will recruit 350 women across 7 sites in Ireland over 3 years.

Dr Fionnuala Ni Ainle, Consultant Hematologist, Rotunda Hospital and Mater Misericordiae University Hospital, said of HIGHLOW;

This funding will help to address an important clinical problem for women in Ireland and worldwide and will provide definitive information on the optimal dose of low molecular weight heparin to use for clot prevention in pregnant women, thereby potentially saving lives and reducing disability and healthcare costs’

Professor Fergal Malone, Master of the Rotunda and co-Chair of the HRB Mother and Baby Clinical Trial Network said;

This is yet further recognition of the capability of the Irish healthcare system to research and solve major health complications of pregnancy. The collaboration of the leading obstetric and paediatric researchers from all over Ireland into a world-class research network will continue to enhance the reputation of Irish medical science while solving maternal health challenges that have global public health implications.

HRB Mother and Baby CTNI Website – www.hrb-mbctni.ie

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