• Early pregnancy azathioprine use and pregnancy outcomes.

      Cleary, Brian J; Kallen, Bengt; Pharmacy Department, Coombe Women and Infants University Hospital, Dublin 8,, Ireland. bcleary@coombe.ie (2012-02-01)
      BACKGROUND: Azathioprine (AZA) is used during pregnancy by women with inflammatory bowel disease (IBD), other autoimmune disorders, malignancy, and organ transplantation. Previous studies have demonstrated potential risks. METHODS: The Swedish Medical Birth Register was used to identify 476 women who reported the use of AZA in early pregnancy. The effect of AZA exposure on pregnancy outcomes was studied after adjustment for maternal characteristics that could act as confounders. RESULTS: The most common indication for AZA use was IBD. The rate of congenital malformations was 6.2% in the AZA group and 4.7% among all infants born (adjusted OR: 1.41, 95% CI: 0.98-2.04). An association between early pregnancy AZA exposure and ventricular/atrial septal defects was found (adjusted OR: 3.18, 95% CI: 1.45-6.04). Exposed infants were also more likely to be preterm, to weigh <2500 gm, and to be small for gestational age compared to all infants born. This effect remained for preterm birth and low birth weight when infants of women with IBD but without AZA exposure were used as a comparison group. A trend toward an increased risk of congenital malformations was found among infants of women with IBD using AZA compared to women with IBD not using AZA (adjusted OR: 1.42, 95% CI: 0.93-2.18). CONCLUSIONS: Infants exposed to AZA in early pregnancy may be at a moderately increased risk of congenital malformations, specifically ventricular/atrial septal defects. There is also an increased risk of growth restriction and preterm delivery. These associations may be confounded by the severity of maternal illness.
    • The efficacy of fibrinogen concentrate compared with cryoprecipitate in major obstetric haemorrhage - an observational study.

      Ahmed, S; Harrity, C; Johnson, S; Varadkar, S; McMorrow, S; Fanning, R; Flynn, C M; O' Riordan, J M; Byrne, B M; Department of Obstetrics and Gynaecology, Coombe Women and Infants University Hospital, Dublin, Ireland. (2012-10)
      Fibrinogen replacement is critical in major obstetric haemorrhage (MOH). Purified, pasteurised fibrinogen concentrate appears to have benefit over cryoprecipitate in ease of administration and safety but is unlicensed in pregnancy. In July 2009, the Irish Blood Transfusion Service replaced cryoprecipitate with fibrinogen.
    • An emergency department intervention to protect an overlooked group of children at risk of significant harm.

      Kaye, P; Taylor, C; Barley, K; Powell-Chandler, A; Emergency Department, Royal United Hospital, Coombe Park, Bath, UK., philip_bath@hotmail.com (2012-02-01)
      BACKGROUND: Parental psychiatric disorder, especially depression, personality disorder and deliberate self-harm, is known to put children at greater risk of mental illness, neglect or physical, emotional and sexual abuse. Without a reliable procedure to identify children of parents presenting with these mental health problems, children at high risk of significant harm can be easily overlooked. Although deliberate self-harm constitutes a significant proportion of emergency presentations, there are no guidelines which address the emergency physician's role in identifying and assessing risk to children of these patients. METHODS: A robust system was jointly developed with the local social services child protection team to identify and risk-stratify children of parents with mental illness. This allows us to intervene when we identify children at immediate risk of harm and to ensure that social services are aware of potential risk to all children in this group. The referral process was audited repeatedly to refine the agreed protocol. RESULTS: The proportion of patients asked by the emergency department personnel about dependent children increased and the quality of information received by the social services child protection team improved. CONCLUSIONS: All emergency departments should acknowledge the inadequacy of information available to them regarding patients' children and consider a policy of referral to social services for all children of parents with mental health presentations. This process can only be developed through close liaison within the multidisciplinary child protection team.
    • Endosomal gene expression: a new indicator for prostate cancer patient prognosis?

      Johnson, Ian R D; Parkinson-Lawrence, Emma J; Keegan, Helen; Spillane, Cathy D; Barry-O'Crowley, Jacqui; Watson, William R; Selemidis, Stavros; Butler, Lisa M; O'Leary, John J; Brooks, Doug A (Impact Publishers, 2015-11-10)
      Prostate cancer continues to be a major cause of morbidity and mortality in men, but a method for accurate prognosis in these patients is yet to be developed. The recent discovery of altered endosomal biogenesis in prostate cancer has identified a fundamental change in the cell biology of this cancer, which holds great promise for the identification of novel biomarkers that can predict disease outcomes. Here we have identified significantly altered expression of endosomal genes in prostate cancer compared to non-malignant tissue in mRNA microarrays and confirmed these findings by qRT-PCR on fresh-frozen tissue. Importantly, we identified endosomal gene expression patterns that were predictive of patient outcomes. Two endosomal tri-gene signatures were identified from a previously published microarray cohort and had a significant capacity to stratify patient outcomes. The expression of APPL1, RAB5A, EEA1, PDCD6IP, NOX4 and SORT1 were altered in malignant patient tissue, when compared to indolent and normal prostate tissue. These findings support the initiation of a case-control study using larger cohorts of prostate tissue, with documented patient outcomes, to determine if different combinations of these new biomarkers can accurately predict disease status and clinical progression in prostate cancer patients.
    • Epidural analgesia practices for labour: results of a 2005 national survey in Ireland.

      Fanning, Rebecca A; Briggs, Liam P; Carey, Michael F; Department of Perioperative Medicine, Coombe Women and Infants University, Hospital, Dublin, Ireland. rebecca.fanning@gmail.com (2012-02-01)
      BACKGROUND AND OBJECTIVE: The last 25 years have seen changes in the management of epidural analgesia for labour, including the advent of low-dose epidural analgesia, the development of new local anaesthetic agents, various regimes for maintaining epidural analgesia and the practice of combined spinal-epidural analgesia. We conducted a survey of Irish obstetric anaesthetists to obtain information regarding the conduct and management of obstetric epidural analgesia in Ireland in 2005. The specific objective of this survey was to discover whether new developments in obstetric anaesthesia have been incorporated into clinical practice. METHODS: A postal survey was sent to all anaesthetists with a clinical commitment for obstetric anaesthesia in the sites approved for training by the College of Anaesthetists, Ireland. RESULTS: Fifty-three per cent of anaesthetists surveyed responded. The majority of anaesthetists (98%) use low-dose epidural analgesia for the maintenance of analgesia. Only 11% use it for test-dosing and 32% for the induction of analgesia. The combined spinal-epidural analgesia method is used by 49%, but two-thirds of those who use it perform fewer than five per month. Patient-controlled epidural analgesia was in use at only one site. CONCLUSION: It appears that Irish obstetric anaesthetists have adopted the low-dose epidural analgesia trend for the maintenance of labour analgesia. This practice is not as widespread, however, for test dosing, the induction of analgesia dose or in the administration of intermittent epidural boluses to maintain analgesia when higher concentrations are used. Since its introduction in 2000, levobupivacaine has become the most popular local anaesthetic agent.
    • Establishing the accuracy and acceptability of abdominal ultrasound to define the foetal head position in the second stage of labour: a validation study.

      Ramphul, Meenakshi; Kennelly, Mairead; Murphy, Deirdre J; Academic Department of Obstetrics & Gynaecology, Trinity College Dublin & Coombe Women & Infant's University Hospital, Dublin 8, Ireland. ramphulm@tcd.ie (2012-09)
      To compare the diagnosis of the foetal head position in the second stage of labour by ultrasound scan performed by a novice sonographer and by clinical assessment, to that of an expert sonographer (gold standard); and to evaluate the acceptability of ultrasound in the second stage of labour to women and clinicians.
    • Evidence-based planning and costing palliative care services for children: novel multi-method epidemiological and economic exemplar

      Noyes, Jane; Edwards, Rhiannon Tudor; Hastings, Richard P; Hain, Richard; Totsika, Vasiliki; Bennett, Virginia; Hobson, Lucie; Davies, Gareth R; Humphreys, Ciarán; Devins, Mary; et al. (2013-04-25)
      Abstract Background Children’s palliative care is a relatively new clinical specialty. Its nature is multi-dimensional and its delivery necessarily multi-professional. Numerous diverse public and not-for-profit organisations typically provide services and support. Because services are not centrally coordinated, they are provided in a manner that is inconsistent and incoherent. Since the first children’s hospice opened in 1982, the epidemiology of life-limiting conditions has changed with more children living longer, and many requiring transfer to adult services. Very little is known about the number of children living within any given geographical locality, costs of care, or experiences of children with ongoing palliative care needs and their families. We integrated evidence, and undertook and used novel methodological epidemiological work to develop the first evidence-based and costed commissioning exemplar. Methods Multi-method epidemiological and economic exemplar from a health and not-for-profit organisation perspective, to estimate numbers of children under 19 years with life-limiting conditions, cost current services, determine child/parent care preferences, and cost choice of end-of-life care at home. Results The exemplar locality (North Wales) had important gaps in service provision and the clinical network. The estimated annual total cost of current children’s palliative care was about £5.5 million; average annual care cost per child was £22,771 using 2007 prevalence estimates and £2,437- £11,045 using new 2012/13 population-based prevalence estimates. Using population-based prevalence, we estimate 2271 children with a life-limiting condition in the general exemplar population and around 501 children per year with ongoing palliative care needs in contact with hospital services. Around 24 children with a wide range of life-limiting conditions require end-of-life care per year. Choice of end-of-life care at home was requested, which is not currently universally available. We estimated a minimum (based on 1 week of end-of-life care) additional cost of £336,000 per year to provide end-of-life support at home. Were end-of-life care to span 4 weeks, the total annual additional costs increases to £536,500 (2010/11 prices). Conclusions Findings make a significant contribution to population-based needs assessment and commissioning methodology in children’s palliative care. Further work is needed to determine with greater precision which children in the total population require access to services and when. Half of children who died 2002-7 did not have conditions that met the globally used children's palliative care condition categories, which need revision in light of findings.
    • Gene expression profiling in cervical cancer: identification of novel markers for disease diagnosis and therapy.

      Martin, Cara M; Astbury, Katharine; McEvoy, Lynda; O'Toole, Sharon; Sheils, Orla; O'Leary, John J; Department of Pathology, Coombe Women's Hospital, Dublin, Ireland. (2012-02-01)
      Cervical cancer, a potentially preventable disease, remains the second most common malignancy in women worldwide. Human papillomavirus is the single most important etiological agent in cervical cancer. HPV contributes to neoplastic progression through the action of two viral oncoproteins E6 and E7, which interfere with critical cell cycle pathways, p53, and retinoblastoma. However, evidence suggests that HPV infection alone is insufficient to induce malignant changes and other host genetic variations are important in the development of cervical cancer. Advances in molecular biology and high throughput gene expression profiling technologies have heralded a new era in biomarker discovery and identification of molecular targets related to carcinogenesis. These advancements have improved our understanding of carcinogenesis and will facilitate screening, early detection, management, and personalised targeted therapy. In this chapter, we have described the use of high density microarrays to assess gene expression profiles in cervical cancer. Using this approach we have identified a number of novel genes which are differentially expressed in cervical cancer, including several genes involved in cell cycle regulation. These include p16ink4a, MCM 3 and 5, CDC6, Geminin, Cyclins A-D, TOPO2A, CDCA1, and BIRC5. We have validated expression of mRNA using real-time PCR and protein by immunohistochemistry.
    • Hepatitis C: is there a case for universal screening in pregnancy?

      Martyn, F; Phelan, O; O'Connell, M; Department of Obstetrics & Gynaecology, Coombe Women & Infant's University, Hospital, Dolphin's Barn, Dublin 8. f_martyn@yahoo.com (2012-02-01)
      Hepatitis C (HCV) is not routinely screened for antenatally in all maternity hospitals. Most hospitals adopt a policy of targeted screening. The policy in the Coombe Women and Infants University Hospital in Dublin changed from targeted screening in 2006 to universal screening in 2007. We audited the two consecutive years. The prevalence of HCV in our antenatal population was 1.4% for 2006 (67/4666) when targeted screening applied and in 2007--0.71% (66/9222) when universal screening came into affect. One woman in 2007 would not have been detected by targeted screening--1.49% (1/67). Fifty five percent (37/67) of women were HCV-RNA positive in 2006 and 57.5% (38/66) were positive in 2007. We conclude that there were similar detection rates for HCV in 2006 and 2007 and that universal screening is not required if inclusive criteria for selective screening are employed but is of use in research context.
    • Hepatitis C: is there a case for universal screening in pregnancy?

      Martyn, F; Phelan, O; O'Connell, M; Department of Obstetrics & Gynaecology, Coombe Women & Infant's University Hospital, Dolphin's Barn, Dublin 8. f_martyn@yahoo.com (2011-05)
      Hepatitis C (HCV) is not routinely screened for antenatally in all maternity hospitals. Most hospitals adopt a policy of targeted screening. The policy in the Coombe Women and Infants University Hospital in Dublin changed from targeted screening in 2006 to universal screening in 2007. We audited the two consecutive years. The prevalence of HCV in our antenatal population was 1.4% for 2006 (67/4666) when targeted screening applied and in 2007--0.71% (66/9222) when universal screening came into affect. One woman in 2007 would not have been detected by targeted screening--1.49% (1/67). Fifty five percent (37/67) of women were HCV-RNA positive in 2006 and 57.5% (38/66) were positive in 2007. We conclude that there were similar detection rates for HCV in 2006 and 2007 and that universal screening is not required if inclusive criteria for selective screening are employed but is of use in research context.
    • How many joints does the 5th toe have? A review of 606 patients of 655 foot radiographs.

      Moulton, Lawrence Stephen; Prasad, Seema; Lamb, Robert G; Sirikonda, Siva P; Department of Orthopaedics, Royal United Hospital Bath NHS Trust, Coombe Park, Bath, United Kingdom. Lawrence.moulton@doctors.net.uk (Elsevier, 2012-12)
      It is a common understanding that the fifth toe has three bones with two interphalangeal joints. However, our experience shows that a significant number have only two phalanges with one interphalangeal joint.
    • How Much Greater is Obstetric Intervention in Women with Medical Disorders in Pregnancy When Compared to the General Population?

      Keane, R.; Manning, C.; Lynch, C.; Regan, C.; Byrne, B. (Irish Medical Journal, 2019-10)
      The purpose of this study was to compare obstetric and neonatal outcomes between women attending a specialised maternal medicine service and the general obstetric population.
    • Human papillomavirus vaccination in the prevention of cervical neoplasia.

      Astbury, Katharine; Turner, Michael J; Department of Obstetrics and Gynaecology, Coombe Women's Hospital, Dublin,, Ireland. kathastbury@gmail.com (2012-02-01)
      Cervical cancer remains a major cause of morbidity and mortality for women worldwide. Although the introduction of comprehensive screening programs has reduced the disease incidence in developed countries, it remains a major problem in the developing world. The recent licensing of 2 vaccines against human papillomavirus (HPV) type 16 and HPV-18, the viruses responsible for 70% of cervical cancer cases, offers the hope of disease prevention. In this article, we review the role of HPV in the etiology of cervical cancer and the evidence to support the introduction of vaccination programs in young women and discuss the potential obstacles to widespread vaccination. In addition, we discuss the issues that remain to be elucidated, including the potential need for booster doses of the vaccine and the role of concomitant vaccination in men.
    • Identifying novel hypoxia-associated markers of chemoresistance in ovarian cancer.

      McEvoy, Lynda M; O'Toole, Sharon A; Spillane, Cathy D; Martin, Cara M; Gallagher, Michael F; Stordal, Britta; Blackshields, Gordon; Sheils, Orla; O'Leary, John J (Springer, 2015)
      Ovarian cancer is associated with poor long-term survival due to late diagnosis and development of chemoresistance. Tumour hypoxia is associated with many features of tumour aggressiveness including increased cellular proliferation, inhibition of apoptosis, increased invasion and metastasis, and chemoresistance, mostly mediated through hypoxia-inducible factor (HIF)-1α. While HIF-1α has been associated with platinum resistance in a variety of cancers, including ovarian, relatively little is known about the importance of the duration of hypoxia. Similarly, the gene pathways activated in ovarian cancer which cause chemoresistance as a result of hypoxia are poorly understood. This study aimed to firstly investigate the effect of hypoxia duration on resistance to cisplatin in an ovarian cancer chemoresistance cell line model and to identify genes whose expression was associated with hypoxia-induced chemoresistance.
    • Impact of a personal learning plan supported by an induction meeting on academic performance in undergraduate Obstetrics and Gynaecology: a cluster randomised controlled trial

      Deane, Richard P; Murphy, Deirdre J; Department of Obstetrics & Gynaecology, Trinity College (BioMed Central, 2015)
      BACKGROUND: A personal learning plan (PLP) is an approach to assist medical students maximise their learning experience within clinical rotations. The aim of this study was to investigate whether medical students who created a PLP supported by an induction meeting had an improved academic performance within an undergraduate clinical rotation. METHODS: A cluster randomised controlled study was conducted over a full academic year (2012/13). The intervention was the creation of a PLP by medical students supported by an individual 'one-to-one' induction meeting between each student and a faculty member. Randomisation was by unit of rotation in which students completed the program. There were 2 clusters in the intervention group (n = 71 students) and 2 clusters in the control group (n = 72 students). Primary outcome was the overall examination score. Secondary outcomes were student attendance and student evaluation. RESULTS: There was no difference in overall examination score between the intervention group and control group (mean score 56.3 ± 4.8% versus 56.7 ± 5.6%, p = 0.64). The majority of students in the intervention group (n = 51/71, 85%) reported that the PLP and induction meeting enhanced their learning experience. Attendance at the induction meeting was identified as a key element. CONCLUSIONS: The creation of a PLP supported by an induction meeting was rated highly by students as an approach to enhance their learning experience but did not result in an improved academic performance. Further research is required to establish the role of an interim or exit meeting.
    • The impact of new national guidelines on screening for gestational Diabetes Mellitus

      Ali, FM; Farah, N; O’Dwyer, V; O’Connor, C; Kennelly, MM; Turner, MJ (Irish Medical Journal, 2013-02)
      Gestational diabetes mellitus (GDM) has important maternal and fetal implications. In 2010, the Health Service Executive published guidelines on GDM. We examined the impact of the new guidelines in a large maternity unit. In January 2011, the hospital replaced the 100g Oral Glucose Tolerance Test (OGTT) with the new 75g OGTT. We compared the first 6 months of 2011 with the first 6 months of 2010. The new guidelines were associated with a 22% increase in women screened from 1375 in 2010 to 1679 in 2011 (p<0.001). Of the women screened, the number diagnosed with GDM increased from 10.1% (n=139) to 13.2% (n=221) (p<0.001).The combination of increased screening and a more sensitive OGTT resulted in the number of women diagnosed with GDM increasing 59% from 139 to 221 (p=0.02).This large increase has important resource implications but, if clinical outcomes are improved, there should be a decrease in long-term costs.
    • The impact of new national guidelines on screening for gestational diabetes mellitus.

      Ali, F M; Farah, N; O'Dwyer, V; O'Connor, C; Kennelly, M M; Turner, M J (2013-02)
      Gestational diabetes mellitus (GDM) has important maternal and fetal implications. In 2010, the Health Service Executive published guidelines on GDM. We examined the impact of the new guidelines in a large maternity unit. In January 2011, the hospital replaced the 100 g Oral Glucose Tolerance Test (OGTT) with the new 75 g OGTT. We compared the first 6 months of 2011 with the first 6 months of 2010. The new guidelines were associated with a 22% increase in women screened from 1375 in 2010 to 1679 in 2011 (p < 0.001). Of the women screened, the number diagnosed with GDM increased from 10.1% (n=139) to 13.2% (n=221) (p<0.001).The combination of increased screening and a more sensitive OGTT resulted in the number of women diagnosed with GDM increasing 59% from 139 to 221 (p = 0.02).This large increase has important resource implications but, if clinical outcomes are improved, there should be a decrease in long-term costs.
    • Implementation of guidelines on oxytocin use at caesarean section: a survey of practice in Great Britain and Ireland.

      Sheehan, Sharon R; Wedisinghe, Lilantha; Macleod, Maureen; Murphy, Deirdre J; Academic Department of Obstetrics & Gynaecology, Coombe Women and Infants, University Hospital & Trinity College, University of Dublin, Dublin 8, Ireland., sharon.sheehan@tcd.ie (2012-02-01)
      OBJECTIVE: Caesarean section is one of the most commonly performed major operations on women worldwide. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. Various clinical guidelines address oxytocin use at the time of caesarean section. We previously reported wide variation in practice amongst clinicians in the United Kingdom in the use of oxytocin at caesarean section. The aim of this current study was to determine whether the variation in approach is universal across the individual countries of Great Britain and Ireland and whether this reflects differences in interpretation and implementation of clinical practice guidelines. STUDY DESIGN: We conducted a survey of practice in the five individual countries of Great Britain and Ireland. A postal questionnaire was sent to all lead consultant obstetricians and anaesthetists with responsibility for the labour ward. We explored the use of oxytocin bolus and infusion, the measurement of blood loss at caesarean section and the rates of major haemorrhage. Existing clinical guidelines from the National Institute for Clinical Excellence (NICE), the Royal College of Obstetricians and Gynaecologists (RCOG) and ALSO (Advanced Life Support in Obstetrics) were used to benchmark reported practice against recommended practice for the management of blood loss at caesarean section. RESULTS: The response rate was 82% (391 respondents). Use of a 5 IU oxytocin bolus was reported by 346 respondents (85-95% for individual countries). In some countries, up to 14% used a 10 IU oxytocin bolus despite recommendations against this. Routine use of an oxytocin infusion varied greatly between countries (11% lowest-55% highest). Marked variations in choice of oxytocin regimens were noted with inconsistencies in the country-specific recommendations, e.g. NICE (which covers England and Wales) recommends a 30 IU oxytocin infusion over 4h, but only 122 clinicians (40%) used this. CONCLUSIONS: Clinicians' approach to the use of oxytocin at the time of caesarean delivery varies between countries. Even in countries with on-site visits to ensure guideline implementation (e.g. Clinical Negligence Scheme for Trusts in England), deviations from guideline recommendations exist. These variations may reflect a lack of robust evidence and the need for future research in this area.
    • The influence of maternal body composition on birth weight.

      Farah, Nadine; Stuart, Bernard; Donnelly, Valerie; Kennelly, Mairead M; Turner, Michael J; UCD Centre for Human Reproduction, Coombe Women and Infants University Hospital, , Dublin, Ireland. nadine.farah@ucd.ie (2012-02-01)
      OBJECTIVE: To identify the maternal body composition parameters that independently influence birth weight. STUDY DESIGN: A longitudinal prospective observational study in a large university teaching hospital. One hundred and eighty-four non-diabetic caucasian women with a singleton pregnancy were studied. In early pregnancy maternal weight and height were measured digitally in a standardised way and the body mass index (BMI) was calculated. At 28 and 37 weeks' gestation maternal body composition was assessed using segmental multifrequency bioelectrical impedance analysis. At delivery the baby was weighed and the clinical details were recorded. RESULTS: Of the women studied, 29.2% were overweight and 34.8% were obese. Birth weight did not correlate with maternal weight or BMI in early pregnancy. Birth weight correlated with gestational weight gain (GWG) before the third trimester (r=0.163, p=0.027), but not with GWG in the third trimester. Birth weight correlated with maternal fat-free mass, and not fat mass at 28 and 37 weeks gestation. Birth weight did not correlate with increases in maternal fat and fat-free masses between 28 and 37 weeks. CONCLUSIONS: Contrary to previous reports, we found that early pregnancy maternal BMI in a non-diabetic population does not influence birth weight. Interestingly, it was the GWG before the third trimester and not the GWG in the third trimester that influenced birth weight. Our findings have implications for the design of future intervention studies aimed at optimising gestational weight gain and birth weight. CONDENSATION: Maternal fat-free mass and gestational weight gain both influence birth weight.
    • Intramuscular oxytocin versus intravenous oxytocin to prevent postpartum haemorrhage at vaginal delivery (LabOR trial): study protocol for a randomised controlled trial.

      Adnan, Nita; Boland, Fiona; Murphy, Deirdre J; Academic Department of Obstetrics and Gynaecology, Trinity College, University of Dublin & Coombe Women & Infants University Hospital, Dublin 8, Ireland/ Department of General Practice, Royal College of Surgeons in Ireland, Dublin 2, Ireland (Biomed Central, 2017-11-15)
      Primary postpartum haemorrhage (PPH) is one of the leading causes of maternal morbidity and mortality worldwide. The most common cause of primary PPH is uterine atony. Atonic PPH rates are increasing in developed countries despite routine active management of the third stage of labour. In less-developed countries, primary PPH remains the leading cause of maternal death. Although the value of routine oxytocics in the third stage of labour has been well established, there is inconsistent practice in the choice of agent and route of administration. Oxytocin is the preferred agent because it has fewer side effects than other uterotonics with similar efficacy. It can be given intravenously or intramuscularly; however, to date, the most effective route of administering oxytocin has not been established. A double-blind randomised controlled trial is planned. The aim of the study is to compare the effects of an intramuscular bolus of oxytocin (10 IU in 1 mL) and placebo intravenous injection (1 mL 0.9% saline given slowly) with an intravenous bolus of oxytocin (10 IU in 1 mL given slowly over 1 min) and placebo intramuscular injection (1 mL 0.9% saline) at vaginal delivery. The study will recruit 1000 women at term (>36 weeks) with singleton pregnancies who are aiming for a vaginal delivery. The primary outcome will be PPH (measured blood loss ≥ 500 mL). A study involving 1000 women will have 80% power at the 5% two-sided alpha level, to detect differences in the proportion of patients with measured blood loss > 500 ml of 10% vs 5%. Given the increasing trends of atonic PPH it is both important and timely that we evaluate the most effective route of oxytocin administration for the management of the third stage of labour. To date, there has been limited research comparing the efficacy of intramuscular oxytocin vs intravenous oxytocin for the third stage of labour. ISRCTN Registry, ISRCTN14718882 . Registered on 4 January 2016. Pilot commenced 12.12.2015; trial commenced 04.01.2016. The protocol (Ref 012012) was approved by the National Maternity Hospital Research Ethics Committee on 10.06.2015 and the Research Ethics Committee of the Coombe Women & Infants University Hospital (Ref 26-2015) on 09.12.2015.