Research – RCSI Rotunda Research Department
The RCSI Rotunda Research Department brings together leading Irish obstetric and neonatal researchers, with an international reputation to address problems in women's and children’s health that will have a global impact. The Rotunda Hospital-based team has a well-established record in collaborative research and in conducting large-scale, multicentre, randomised controlled trials, as well as education and outreach initiatives.
The RCSI-Rotunda consultant team comprises of:
- Prof. Fergal Malone, Consultant Maternal Fetal Medicine and Chairman RCSI Obstetrics and Gynaecology
- Prof. Fionnuala Breathnach, Consultant Obstetrician Gynaecologist and RCSI Associate Professor
- Dr Karen Flood, Consultant Obstetrician Gynaecologist and RCSI Senior Lecturer
- Dr Niamh Daly, Consultant Obstetrician Gynaecologist and RCSI Senior Lecturer
- Dr Naomi Burke, Consultant Obstetrician Gynaecologist and RCSI Senior Lecturer
- Prof. Afif El-Khuffash, Consultant Neonatologist and Paediatrician and RCSI Clinical Professor
The RCSI-Rotunda research support team comprises of:
- Dr Zara Molphy, Head of Research Programmes
- Denisa Asandei, Clinical Operations Manager
- Elisa Belmonte, Communications Manager
- Sirisha Bellamkonda, Trial Coordinator
- Hollie Byrne, Research Assistant
- Sarah Marcu, Research Assistant
The research team also provide support to a wider network of consultants both on-site at the Rotunda and off-site, including:
- Prof. Jennifer Donnelly, Consultant Obstetrician, The Rotunda/The Mater Hospital
- Prof. Fionnuala Ni Ainle, Consultant Haematologist, The Rotunda/The Mater Hospital
- Dr Carmen Regan, Consultant Obstetrician, The Coombe Hospital and RCSI Senior Lecturer
- Dr Neil O’Gorman, Consultant Obstetrician, The Coombe Hospital
- PhD/MSc/MD candidates
Interventional clinical research portfolio
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
- Co-Investigator: 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.
HOME IND – 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.
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 Coordinator: Denisa Asandei
A single site randomised controlled trial 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 Coordinator: 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.
ACEDUCT – Co-administration of Acetaminophen with Ibuprofen to improve duct-related outcomes in extremely premature infants
- Principal Investigator: Prof. Afif El-Khuffash
- Co-Investigator: Dr Rachel Mullaly
To evaluate the clinical impact, efficacy and safety of combination regime (Ibuprofen and Acetaminophen) for first treatment course for significant PDA in extremely low gestational age neonates (ELGANs) versus Ibuprofen alone.
PROTECT – Pentoxifylline to improve long-term outcomes in preterm infants with late-onset sepsis or necrotising enterocolitis
- Principal Investigator (Rotunda site): Prof. Afif El-Khuffash
The aim of PROTECT is to investigate whether intravenous pentoxyfylline (PTX) versus placebo increase survival without disability at 24 months of age in infants born at less than 29 weeks gestation with late onset sepsis or necrotising enterocolitis.
Non-interventional clinical research
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.
DIONYSUS – International registry for the management and clinical outcomes in hemolytic disease of the fetus and newborn
- Principal Investigator (Rotunda site): Prof. Fergal Malone
- Sub Investigator: Dr David Mackin
This is an international multicentre observational cohort study to assess differences in prenatal and postnatal management strategies and clinical outcomes of haemolytic disease of the fetus and newborn (HDFN) in cases with moderate to severe HDFN due to Rhesus, Kell or other types of red blood cell antigen alloimmunisation, managed at expert fetal therapy centres worldwide.
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.
Recently closed clinical trials (2022/23)
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.