Obstetrics and Gynaecology - Research Publications
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ItemCharacteristics of patients with cancer who die by suicide: Coronial case series in an Australian state(WILEY, 2019-11)OBJECTIVE: Suicide rates are elevated in epidemiological studies, but extrapolating population level data to the individual patient cancer is difficult, and there is a dearth of studies examining how suicidality might be linked to the cancer experience. We examine the cancer-suicide correlates to explore clinical implications and future research directions. METHOD: We used a novel database to examine all suicide deaths reported to the Coroners Court of Victoria between 2009 and 2013 in individuals with active, diagnosed cancer. Cases were classified in relation to whether cancer had been a probable, possible, or unlikely influence on suicidal ideation. Sociodemographic, clinical, health service contacts, and suicide method data were analysed to describe the characteristics of individuals with cancer at the time of their suicide. RESULTS: There were 2870 suicide deaths, and 118 cases met inclusion criteria. Clinically distinct patient subgroups emerged through a contrast between those cases where the data suggested a correlate between cancer and suicide, and those where the data did not. The former group had many more cancer-related health problems than the latter group, who had a higher burden of psychiatric illness that predated their cancer diagnosis. The intent to suicide was known to most clinicians. CONCLUSIONS: All clinicians working with cancer patients should be prepared to explore suicidal ideation. Understanding how the patient conceptualises suicidality with respect to cancer experience and mental health may be of central importance in determining whether mental health care is best provided as part of cancer care, or through a separate mental health service.
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ItemInferior load generated by preloaded versus manually loaded haemorrhoid banding devices: the effect of 'creep relaxation'(WILEY, 2019-11)BACKGROUND: The efficacy of rubber band ligation of haemorrhoids relies on the load generated on haemorrhoidal tissue by bands as they return to their preformed shape after being deployed. 'Preloaded' haemorrhoid banding devices are widely available, but the effect of the resultant prolonged stretch on bands while stored in this manner has never been examined by comparing these to manually loaded devices, which are stretch immediately prior to being deployed. A difference could have clinical relevance, potentially resulting in a higher rate of clinical failure. The present study aimed to investigate any difference in load generated by preloaded versus manually loaded devices. METHODS: A preloaded and a manually loaded device were selected for comparison. Each type was measured on a testing rig. The device type, load generated by each band and the time to expiry were recorded. RESULTS: A total of 137 haemorrhoid bands were tested: 66 preloaded and 71 manually loaded. There was a statistically significant overall reduction in load generated by preloaded versus manually loaded devices (284.0 versus 272.1 g, mean difference -11.9 g, 95% confidence interval -17.5 to -6.3 g, P = 0.0001). Adjusted for time, the load generated by preloaded bands fell 3.7 g (95% confidence interval 2.7-4.8, P < 0.001) for each month closer to the expiry date. CONCLUSIONS: The load generated by haemorrhoid bands from preloaded devices is lower and deteriorates significantly towards their expiry date compared with bands from manually loaded devices. This is mostly likely due to their storage in a stretched state. This should be considered by clinicians when using haemorrhoid banding devices.
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ItemEstimating success of vaginal birth after caesarean section in a regional Australian population: Validation of a prediction model(WILEY, 2019-02)BACKGROUND: Following a primary caesarean section (CS), women must decide between attempted vaginal birth after caesarean (VBAC) and elective repeat caesarean section (ERCS) in subsequent pregnancies. Both options carry potential morbidity and mortality for mother and child, with the most feared being uterine rupture and its consequences. In attempts to reduce morbidity, several predictive nomograms have been developed to assist in delivery mode decisions. AIM: To assess the validity of the predictive nomogram developed by Grobman et al. in our regional Australian population. MATERIALS AND METHODS: In our retrospective analysis, patients at term, with one previous CS who had a trial of labour were assigned a 'Grobman score' based on antenatal details. Outcomes were noted and patient groups analysed according to percentage deciles of estimated VBAC success, compared with actual VBAC success rates. RESULTS: A total of 395 women underwent trial of labour after a single prior CS, with a VBAC success rate of 83%. The Grobman model displayed adequate calibration and the re-calibrated model good calibration with the slope coefficient of 0.87 (95% CI 0.54-1.19) and intercept 0.19 (95% CI -0.34-0.72). Discrimination was moderate with receiver operating characteristic area of 0.71 (95% CI 0.67-0.76). CONCLUSION: This analysis supports further validation studies in larger Australian settings, and suggests that use of the original Grobman predictive nomogram may be appropriate in Australia.
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ItemCustomised growth charts in large-for-gestational-age infants and the association with emergency caesarean section rate(WILEY, 2019-06)BACKGROUND AND AIM: Large-for-gestational-age (LGA) infants are at increased risk of intrapartum complications. However, some infants classified as LGA may be appropriate-for-gestational-age (AGA) if adjusted for maternal stature. We determined whether customisation of birthweight centiles by maternal height, or height and weight, improves the detection of LGA infants at risk of complications. METHODS: We conducted a retrospective analysis of 38 246 term, singleton nulliparous women. We compared population birthweight centiles to those customised by height, or height and weight for complications including intrapartum caesarean section, instrumental delivery, postpartum haemorrhage, anal sphincter injury and neonatal outcomes. RESULTS: Those considered LGA when customised for height but AGA by population centiles (LGA-ht-only) were at increased risk of intrapartum emergency caesarean section compared with infants AGA on all charts (AGA-all); odds ratio (OR) 4.64, 95% CI 3.22-6.76. In contrast, infants considered LGA on population charts, but AGA when customised by height (LGA-pop-only) were not at increased risk compared to the AGA-all group (OR 1.43, 95% CI 0.70-1.88). Infants classified as LGA-ht-only compared to LGA-pop-only remained at significantly higher risk after adjustment for potential confounders (aOR 3.27; 95% CI 2.02-5.31). No difference was seen for any other outcomes. No benefit was seen with customisation by both maternal height and weight. CONCLUSION: Women with an infant classified as AGA on population centiles but LGA when customised for height are at increased risk of intrapartum caesarean section. This is a population unrecognised in current practice. Fetal growth should be customised for maternal height when making assessments regarding the LGA infant.
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ItemPelvic organ prolapse surgery with and without tension-free vaginal tape in women with occult or asymptomatic urodynamic stress incontinence: a randomised controlled trial(SPRINGER LONDON LTD, 2014-01)INTRODUCTION: We set out to determine if insertion of a retropubic tension-free vaginal tape (TVT) sling at the time of pelvic organ prolapse surgery improves continence outcomes in women with pre-operative occult stress incontinence (OSI) or asymptomatic urodynamic stress incontinence (USI). METHODS: We conducted a randomised controlled study of prolapse surgery with or without a TVT midurethral sling. The pre- and post-operative assessment at 6 months included history, physical examination and urodynamic testing. Quality of life (QOL) and treatment success was assessed with the UDI-6 SF, IIQ-7 SF and a numerical success score. The primary outcome was symptomatic stress urinary incontinence (SUI) requiring continence surgery (TVT) at 6 months. Long-term follow-up continued to a minimum of 24 months. Secondary outcomes were quality of life parameters. RESULTS: Eighty women received prolapse surgery alone (n = 43) or prolapse surgery with concurrent TVT (n = 37). Six months following prolapse surgery 3 out of 43 (7 %) patients in the no TVT group requested sling surgery compared with 0 out of 37 (0 %) in the TVT group (ARR 7 % [95 %CI: 3 to 19 %], p = 0.11). After 24 months there was one further participant in the no TVT group who received a TVT for treatment of SUI compared with none in the TVT group (4 out of 43, 9.3 % versus 0 out of 37; ARR 9.3 % [95 %CI: -1 to 22 %], p = 0.06). Both groups showed improvement in QOL difference scores for within-group analysis, without difference between groups. CONCLUSION: These results support a policy that routine insertion of a sling in women with OSI at the time of prolapse repair is questionable and should be subject to shared decision-making between clinician and patient.
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ItemDouble blind, randomised, placebo-controlled trial to evaluate the efficacy of esomeprazole to treat early onset pre-eclampsia (PIE Trial): a study protocol(BMJ PUBLISHING GROUP, 2015)INTRODUCTION: Pre-eclampsia is a major complication of pregnancy, globally responsible for 60 000 maternal deaths per year, and far greater numbers of fetal losses. There is no definitive treatment other than delivery. A drug that can quench the disease process could be useful to treat early onset pre-eclampsia, as it could allow pregnancies to safely continue to a gestation where fetal outcomes are significantly improved. We have generated preclinical data to show esomeprazole, a proton pump inhibitor used for gastric reflux, has potent biological effects that makes it a worthwhile therapeutic candidate. Esomeprazole potently decreases soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin secretion from placenta and endothelial cells, and has biological actions to mitigate endothelial dysfunction and oxidative stress. METHODS AND ANALYSIS: We propose undertaking a phase II, double blind, randomised controlled clinical trial to examine whether administering 40 mg esomeprazole daily may prolong gestation in women with early onset pre-eclampsia. We will recruit 120 women (gestational age of 26+0 to 31+6 weeks) who will be randomised to receive either esomeprazole or an identical placebo. The primary outcome will be the number of days from randomisation to delivery. Secondary outcomes include maternal, fetal and neonatal composite and individual outcomes. Maternal outcomes include maternal death, eclampsia, pulmonary oedema, severe renal impairment, cerebral vascular events and liver haematoma or rupture. Neonatal outcomes include neonatal death within 6 weeks after the due date, intraventricular haemorrhage, necrotising enterocolitis and bronchopulmonary dysplasia. We will examine whether esomeprazole can decrease serum sFlt-1 and soluble endoglin levels and we will record the safety of esomeprazole in these pregnancies. ETHICS AND DISSEMINATION: This study has ethical approval (Protocol V.2.4, M14/09/038, Federal Wide assurance Number 00001372, IRB0005239), and is registered with NHREC (ID 3649) and the Pan African Clinical Trial Registry (PACTR201504000771349). Data will be presented at international conferences and published in peer-reviewed journals.
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ItemWarmed, humidified CO2 insufflation benefits intraoperative core temperature during laparoscopic surgery: A meta-analysis(WILEY, 2017-05)BACKGROUND: Intraoperative hypothermia is linked to postoperative adverse events. The use of warmed, humidified CO2 to establish pneumoperitoneum during laparoscopy has been associated with reduced incidence of intraoperative hypothermia. However, the small number and variable quality of published studies have caused uncertainty about the potential benefit of this therapy. This meta-analysis was conducted to specifically evaluate the effects of warmed, humidified CO2 during laparoscopy. METHODS: An electronic database search identified randomized controlled trials performed on adults who underwent laparoscopic abdominal surgery under general anesthesia with either warmed, humidified CO2 or cold, dry CO2 . The main outcome measure of interest was change in intraoperative core body temperature. RESULTS: The database search identified 320 studies as potentially relevant, and of these, 13 met the inclusion criteria and were included in the analysis. During laparoscopic surgery, use of warmed, humidified CO2 is associated with a significant increase in intraoperative core temperature (mean temperature change, 0.3°C), when compared with cold, dry CO2 insufflation. CONCLUSION: Warmed, humidified CO2 insufflation during laparoscopic abdominal surgery has been demonstrated to improve intraoperative maintenance of normothermia when compared with cold, dry CO2.
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ItemTiming of palliative care referral and aggressive cancer care toward the end-of-life in pancreatic cancer: a retrospective, single-center observational study(BMC, 2019-01-28)BACKGROUND: Pancreatic cancer is noted for its late presentation at diagnosis, limited prognosis and physical and psychosocial symptom burden. This study examined associations between timing of palliative care referral (PCR) and aggressive cancer care received by pancreatic cancer patients in the last 30 days of life through a single health service. METHOD: A retrospective cohort analysis of end-of-life (EOL) care outcomes of patients with pancreatic cancer who died between 2012 and 2016. Key indicators of aggressive cancer care in the last 30 days of life used were: ≥1 emergency department (ED) presentations, acute inpatient/intensive care unit (ICU) admission, and chemotherapy use. We examined time from PCR to death and place of death. Early and late PCR were defined as > 90 and ≤ 90 days before death respectively. RESULTS: Out of the 278 eligible deaths, 187 (67.3%) were categorized as receiving a late PCR and 91 (32.7%) an early PCR. The median time between referral and death was 48 days. Compared to those receiving early PCR, those with late PCR had: 18.1% (95% CI 6.8-29.4%) more ED presentations; 12.5% (95% CI 1.7-24.8%) more acute hospital admissions; with no differences in ICU admissions. Pain and complications of cancer accounted for the majority of overall ED presentations. Of the 166 patients who received chemotherapy within 30 days of death, 23 (24.5%) had a late PCR and 12 (16.7%) an early PCR, with no association of PCR status either unadjusted or adjusted for age or gender. The majority of patients (55.8%) died at the inpatient palliative care unit. CONCLUSION: Our findings reaffirm the benefits of early PCR for pancreatic cancer patients to avoid inappropriate care toward the EOL. We suggest that in modern cancer care, there can sometimes be a need to reconsider the use of the term 'aggressive cancer care' at the EOL when the care is appropriately based on an individual patient's presenting physical and psychosocial needs. Pancreatic cancer patients warrant early PCR but the debate must thus continue as to how we best achieve and benchmark outcomes that are compatible with patient and family needs and healthcare priorities.
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ItemA double blind, randomised, placebo-controlled trial to evaluate the efficacy of metformin to treat preterm pre-eclampsia (PI2 Trial): study protocol(BMJ PUBLISHING GROUP, 2019-06)INTRODUCTION: Pre-eclampsia is a major complication of pregnancy, globally responsible for 60 000 maternal deaths per year, and far more fetal losses. There is no definitive treatment other than delivery. A therapeutic that could quench the disease process would be useful to treat preterm pre-eclampsia, as it could allow these pregnancies to safely continue to a gestation where fetal outcomes are significantly improved. We have published preclinical data to show that metformin, a drug known to be safe in pregnancy and commonly used to treat gestational diabetes, has potent biological effects making it another promising candidate to treat pre-eclampsia. Here, we describe a phase II clinical trial to examine whether administering extended-release metformin may be effective in treating women with preterm pre-eclampsia (PI2 Trial). METHODS: The PI2 Trial is a phase II, double blind, randomised controlled trial that aims to recruit 150 women with preterm pre-eclampsia (gestational age 26+0 to 31+6 weeks) who are being managed expectantly. Participants will be randomised to receive either 3 g of metformin or placebo daily. The primary outcome is time from randomisation until delivery. A delay in delivery of 5 days is assumed to be clinically relevant. The secondary outcomes will be a maternal composite and neonatal composite outcome. All other outcomes will be exploratory. We will record adverse events. ETHICS AND DISSEMINATION: This study has ethical approval (Protocol number M16/09/037 Federal Wide Assurance Number 00001372, Institutional Review Board Number IRB0005239), is registered with the Pan African Clinical Trial Registry (PACTR201608001752102) and the South African Medicine Control Council (20170322). Data will be presented at international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: PACTR201608001752102; Pre-results.
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ItemIdentification of the optimal growth charts for use in a preterm population: An Australian state-wide retrospective cohort study(PUBLIC LIBRARY SCIENCE, 2019-10)BACKGROUND: Preterm infants are a group at high risk of having experienced placental insufficiency. It is unclear which growth charts perform best in identifying infants at increased risk of stillbirth and other adverse perinatal outcomes. We compared 2 birthweight charts (population centiles and INTERGROWTH-21st birthweight centiles) and 3 fetal growth charts (INTERGROWTH-21st fetal growth charts, World Health Organization fetal growth charts, and Gestation Related Optimal Weight [GROW] customised growth charts) to identify which chart performed best in identifying infants at increased risk of adverse perinatal outcome in a preterm population. METHODS AND FINDINGS: We conducted a retrospective cohort study of all preterm infants born at 24.0 to 36.9 weeks gestation in Victoria, Australia, from 2005 to 2015 (28,968 records available for analysis). All above growth charts were applied to the population. Proportions classified as <5th centile and <10th centile by each chart were compared, as were proportions of stillborn infants considered small for gestational age (SGA, <10th centile) by each chart. We then compared the relative performance of non-overlapping SGA cohorts by each chart to our low-risk reference population (infants born appropriate size for gestational age [>10th and <90th centile] by all intrauterine charts [AGAall]) for the following perinatal outcomes: stillbirth, perinatal mortality (stillbirth or neonatal death), Apgar <4 or <7 at 5 minutes, neonatal intensive care unit admissions, suspicion of poor fetal growth leading to expedited delivery, and cesarean section. All intrauterine charts classified a greater proportion of infants as <5th or <10th centile than birthweight charts. The magnitude of the difference between birthweight and fetal charts was greater at more preterm gestations. Of the fetal charts, GROW customised charts classified the greatest number of infants as SGA (22.3%) and the greatest number of stillborn infants as SGA (57%). INTERGROWTH classified almost no additional infants as SGA that were not already considered SGA on GROW or WHO charts; however, those infants classified as SGA by INTERGROWTH had the greatest risk of both stillbirth and total perinatal mortality. GROW customised charts classified a larger proportion of infants as SGA, and these infants were still at increased risk of mortality and adverse perinatal outcomes compared to the AGAall population. Consistent with similar studies in this field, our study was limited in comparing growth charts by the degree of overlap, with many infants classified as SGA by multiple charts. We attempted to overcome this by examining and comparing sub-populations classified as SGA by only 1 growth chart. CONCLUSIONS: In this study, fetal charts classified greater proportions of preterm and stillborn infants as SGA, which more accurately reflected true fetal growth restriction. Of the intrauterine charts, INTERGROWTH classified the smallest number of preterm infants as SGA, although it identified a particularly high-risk cohort, and GROW customised charts classified the greatest number at increased risk of perinatal mortality.