Clinical

Trials

see trials recruiting, ongoing, and complete

Interventional clinical research portfolio

PROTECT - Pentoxifylline to improve long-term outcomes in preterm infants with late-onset sepsis or necrotizing 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

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 (2022-2024)

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 Karen Flood 
  • Sub-Investigator(s): Dr Catherine Finnegan, Dr Sarah Nicholson 
  • 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

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.

 

 

Complete 

PARROT

Placental growth factor in assessment of women with preeclampsia to reduce maternal morbidity

 

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PDA

A randomised controlled trial of early targeted patent ductus arteriosus treatment sing a risk-based severity score

 

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T21

Longitudinal assessment of cardiac function in infants with Downs syndrome using novel echocardiography techniques

 

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HIGHLOW

To evaluate the efficacy and safety of intermediate dose LMWH versus fixed low dose LMWH in pregnant women with a history of previous VTE

 

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RECIPE

Reducing emergency caesareans and improving primiparous experience

 

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SMART

SNP-based microdeletion and aneuploidy registry

 

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HIP

Management of hypotension in the preterm extremely low gestational age newborn

 

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F-Point

A clinical study to define precision, accuracy, and comparability of results from a novel point of care fibrinogen assay (f-point), compared to an industry standard, in the clinical setting

 

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GBS

Prospective practical evaluation of intrapartum screening for maternal GBS carriage

 

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HANDLE

A study identifying abnormal haemodynamic profiles in pregnancy as a predictor of adverse obstetric outcome and characterisation of neonatal myocardial performance in infants

 

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ANSeR

The algorithm for neonatal seizure recognition

 

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AFFIRM

Can promoting awareness of fetal movements and focusing on interventions reduce fetal mortality? A stepped wedge cluster randomised trial

 

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TEST

An open-label randomised-controlled trial of low dose aspirin with an early screening test for preeclampsia and growth restriction

 

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Epidural Related Maternal Fever Study

A study to assess why some mothers develop fever associated with epidural in labour

 

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HOTPOT

Can sonographic assessment of pulmonary vascular reactivity following maternal hyperoxygenation therapy predict neonatal outcome in fetuses at risk of pulmonary hypertension?

 

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INTERACT

Pilot study to investigate the role of ultrasound guidance during evacuation of retained products of conception

 

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MINT

The use of milrinone in neonates with persistent pulmonary hypertension of the newborn

 

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H2020 BigMedilytics

A study that aims to improve monitoring and patient outcomes in a cohort of women with gestational diabetes through a remote monitoring device involving big data technologies

 

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