AI_PREMie – Artificial intelligence to prevent preterm birth due to preeclampsia while protecting mothers lives

• Principal Investigator: Prof. Fionnuala Ni Ainle
• Sub Investigator: Prof. Jennifer Donnelly
• Study Coordinator: Sirisha Bellamkonda

This is an Science Foundation Ireland-funded, award-winning project launched in 2020 in which the Rotunda has partnered with UCD, National Maternity Hospital and The Coombe Hospital to evaluate a combination of patient biomarker testing and risk assessment powered by machine-learning to diagnose preeclampsia and predict patient outcomes.

For more information please visit aipremie.com.

PERIMETER – Perinatal outcomes of early-onset fetal growth restriction: a retrospective observational study

• Principal Investigator: Prof. Fergal Malone
• Sub Investigators: Dr Rocco Cuzzilla and Dr David Mackin
• Study Coordinator: Denisa Asandei

The aim of the PERIMETER study is to evaluate perinatal mortality and morbidity associated with early-onset fetal growth restriction (FGR) in Ireland. There is a pressing need to describe further the perinatal outcomes of early-onset FGR, particularly at periviable gestations, to inform clinical decision-making. Tertiary perinatal centres across Dublin have a standardised approach to diagnosis and management of early onset FGR, providing an opportunity to report outcomes of this high-risk population in a local context.

IRELAnD – Investigating the role of early low-dose aspirin in diabetes: a phase III multicentre double-blinded, placebo-controlled randomised trial of low-dose aspirin initiated in the first trimester of diabetes pregnancy 

• Principal Investigator: Prof. Fionnuala Breathnach 
• Sub-Investigator(s): Dr Catherine Finnegan
• Trial Coordinator: Denisa Asandei 

This is a multicentre randomised conrtolled trial investigating the role of aspirin in pregnancy outcomes of women with pre-gestational diabetes. The trial is led by the Rotunda Hospital and is also recruiting patients at The Coombe Women & Infants University Hospital, National Maternity Hospital, Our Lady of Lourdes Hospital Drogheda, Galway University Hospital and Cork University Maternity Hospital. 

The results of this trial were recently published on the Americal Journal of Obstetrics and Gynaecology

HOME INDUCTION – A randomised open-label trial to assess outpatient induction of labour and compare efficacy of Propess vs Dilapan-S® for induction of labour at 39 weeks’ gestation in normal risk nulliparous women. 

• Principal Investigator: Prof. Fergal Malone 
• Co-Investigator: Dr Sarah Nicholson 
• Trial Coordinator: Sirisha Bellamkonda 

A randomised open-label trial to assess different methods of outpatient induction of labour and compare the efficacy of a prostaglandin vaginal insert (Propess) versus a non-pharmacologic cervical dilator (Dilapan) for induction of labour at 39 weeks’ gestation in normal risk nulliparous women. 

https://youtu.be/Knt7gALRCq4 

PIPELLE – Is pipelle biopsy of benefit in patients with postmenopausal bleeding and atrophic-appearing cavity? 

Principal Investigator: Dr Naomi Burke 

Co-Investigator: Dr Liz Tunney 

Trial Co-ordinator: Denisa Asandei 

A single site RCT to investigate whether the Pipelle endometrial sampling device is of benefit in patients with postmenopausal bleeding and an atrophic-appearing uterine cavity. Differences in pain scores, cost saving and differences in clinical follow up will be assessed to evaluate the benefit of Pipelle biopsy in patients with PMB and atrophic-appearing cavity. 

PARTUM – Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity 

Principal Investigator: Prof Jennifer Donnelly 

Trial Co-ordinator: Sirisha Bellamkonda 

A pilot trial to determine whether low-dose aspirin (ASA) is efficacious and safe at preventing postpartum venous thromboembolism (VTE) in women at increased risk of VTE, compared to placebo. 

https://youtu.be/2rx1E5bIDIw

HIGHLOW – Intermediate-dose versus low-dose low-molecular-weight heparin in pregnant and post-partum women with a history of venous thromboembolism: an open-label, multicentre, randomised controlled trial

• Principal Investigator: Prof. Fionnuala Ni Ainle
• Sub Investigator: Prof. Jennifer Donnelly

HIGHLOW was a randomised controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy.

For more information on HIGHLOW please see The Lancet publication here or view the interview with Prof. Fionnuala Ni Ainle and Prof. Jennifer Donnelly below.