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.

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.

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 + Acetaminophen] for first treatment course for significant PDA in extremely low gestational age neonates (ELGANs) vs. Ibuprofen alone.

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.

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.

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.