Obstetrics and Gynaecology - Research Publications
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ItemThe impact of sample storage on molecular-based detection of Mycoplasma genitalium(OXFORD UNIV PRESS, 2019-10)AIMS: Mycoplasma genitalium causes a common, sexually transmitted bacterial infection. This study assessed the detection of M. genitalium in stored urine samples to understand the impact of sample storage on M. genitalium detection. METHODS: Aliquots of M. genitalium-positive urine (n = 20 patients) were stored at either room temperature (22°C) or 4°C, without a preservative. At weekly intervals, samples were tested using the commercial test ResistancePlus MG® (SpeeDx® , Australia). We report the analysis at 1 week, an acceptable collection-to-test turnaround time, with further analysis over 5 weeks to illustrate degradation trends. RESULTS: After storing at 4°C, the proportion of specimens that remained positive for M. genitalium was 100% after 1 week and 95% after 4 weeks. Storage at 22°C led to more rapid decline in detection in the first 4 weeks, with 95% detected after 1 week and 85% at 2 weeks onwards. At 5 weeks, samples stored at both temperatures had an 85% M. genitalium detection rate, with increase in crossing points (Cq) of 0·72 (95% confidence interval (CI) 0·01-1·43; P-trend = 0·027) at 4°C, and 1·75 ((95% CI 0·79-2·71), P-trend <0·001) at 22°C. CONCLUSIONS: Urine samples stored without preservative, and unfrozen, retained high M. genitalium detection levels over the short term (up to 5 weeks). To minimize degradation, storing at 4°C is recommended. SIGNIFICANCE AND IMPACT OF THE STUDY: There is little known about the stability of clinical samples for M. genitalium detection. This study found that a high proportion (85-100%) of samples are still suitable for M. genitalium detection after storage for up to 5 weeks.
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ItemRoutine cervical screening by primary HPV testing: early findings in the renewed National Cervical Screening Program(WILEY, 2019-08)OBJECTIVES: To report human papillomavirus (HPV) testing patterns and rates of oncogenic HPV-positivity for specimens submitted during the first 6 months after the National Cervical Screening Program switched from cytology- to primary HPV-based screening. DESIGN, PARTICIPANTS: Retrospective cross-sectional review of 195 606 specimens submitted for HPV testing, 1 December 2017 - 31 May 2018. SETTING: Large community-based general pathology laboratory in metropolitan Sydney. MAIN OUTCOME MEASURES: Prevalence of oncogenic HPV types (all, HPV16/18, non-HPV16/18) by reason for HPV test (primary screening, non-screening); for oncogenic HPV-positive women in the age band recommended for primary HPV screening (25-74 years), prevalence of cytologic abnormality and rates of 12-month follow-up and colposcopy recommendations. RESULTS: 195 606 samples were received: 157 700 (80.6%) for primary screening, 37 906 (19.4%) for non-screening tests. Oncogenic HPV was detected in 8.1% of screening tests (95% CI, 7.9-8.2%) and 20.9% of non-screening tests (95% CI, 20.5-21.3%); 35.5% (95% CI, 34.7-36.4%) of women of recommended screening age with positive oncogenic HPV screening test results also had a cytologic abnormality. The proportion of HPV16/18-positive samples with high grade abnormality was 15.3% (95% CI, 14.2-16.6%); for samples positive for other oncogenic HPV types, the proportion was 6.3% (95% CI, 5.8-6.8%). Repeat HPV testing after 12 months was recommended for 5.4% (95% CI, 5.3-5.5%) and direct colposcopy for 2.6% (95% CI, 2.5-2.7%) of screened women aged 25-74 years. CONCLUSIONS: High grade cytologic abnormalities were more common in women positive for HPV16/18, supporting their higher risk classification. Colposcopy referral rates were higher than during primary cytology-based testing, as predicted by clinical trial and modelling data. The prevalence of HPV was much higher in non-screening than in primary screening samples. Our findings indicate the renewed program is performing as expected during the initial HPV screening round.
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ItemCompliance with screening for and recommended management of maternal group B streptococcus carriage in pregnancy(WILEY, 2019-12)BACKGROUND: Universal screening of pregnant women at 35-37 weeks gestation is recommended for detection of anogenital group B streptococcus carriage. Intrapartum chemoprophylaxis is prescribed to carriers to prevent transmission to babies, reducing early-onset neonatal group B streptococcal sepsis. AIMS: To review compliance with, and the effects of education on group B streptococcus screening and intrapartum chemoprophylaxis practices at The Royal Women's Hospital, Melbourne, Australia. MATERIALS AND METHODS: A retrospective audit of women delivering in February 2016 and February-March 2017 was conducted. In February 2017, updated early-onset group B streptococcal disease prevention guidelines were released and promoted with targeted education of clinical staff. Compliance was considered appropriate if practices followed up-to-date local protocols. RESULTS: Screening rate for group B streptococcus was 84.4% (599/710) and carriage rate 19.5% (109/558), while intrapartum antibiotic prophylaxis was optimal in 83% of those labouring greater than four hours (39/47). There was no significant difference in compliance between 2016 and 2017. Of 113 women with unknown group B streptococcal status at delivery, only five of 33 (15%) with clinical risk factors for early-onset neonatal disease received intrapartum prophylaxis. CONCLUSIONS: Compliance remained stable, with no change during or after implementation of new protocols. Compliance with protocols was low for cases with unknown group B streptococcal status at delivery but with the presence of one or more clinical risk factors for early-onset group B streptococcal sepsis.
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ItemPoint-of-care testing and treatment of sexually transmitted infections to improve birth outcomes in high-burden, low-income settings: Study protocol for a cluster randomized crossover trial (the WANTAIM Trial, Papua New Guinea).(F1000 Research Ltd, 2019)Background: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infections in pregnancy. Newly available diagnostic technologies make it possible, for the first time, to conduct definitive field trials to fill this knowledge gap. The primary aim of this study is to evaluate whether antenatal point-of-care testing and immediate treatment of these curable sexually transmitted and genital infections (STIs) leads to reduction in preterm birth and low birth weight. Methods: The Women and Newborn Trial of Antenatal Interventions and Management (WANTAIM) is a cluster-randomised crossover trial in Papua New Guinea to compare point-of-care STI testing and immediate treatment with standard antenatal care (which includes the WHO-endorsed STI 'syndromic' management strategy based on clinical features alone without laboratory confirmation). The unit of randomisation is a primary health care facility and its catchment communities. The primary outcome is a composite measure of two events: the proportion of women and their newborns in each trial arm, who experience either preterm birth (delivery <37 completed weeks of gestation as determined by ultrasound) and/or low birth weight (<2500 g measured within 72 hours of birth). The trial will also evaluate neonatal outcomes, as well as the cost-effectiveness, acceptability and health system requirements of this strategy, compared with standard care. Conclusions: WANTAIM is the first randomised trial to evaluate the effectiveness, cost-effectiveness, acceptability and health system requirements of point-of-care STI testing and treatment to improve birth outcomes in high-burden settings. If the intervention is proven to have an impact, the trial will hasten access to these technologies and could improve maternal and neonatal health in high-burden settings worldwide. Registration: ISRCTN37134032.
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ItemPoint-of-care testing and treatment of sexually transmitted infections to improve birth outcomes in high-burden, low-income settings: Study protocol for a cluster randomized crossover trial (the WANTAIM Trial, Papua New Guinea)(F1000 Research Ltd, 2019-03-22)Background: Chlamydia trachomatis , Neisseria gonorrhoeae , Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infections in pregnancy. Newly available diagnostic technologies make it possible, for the first time, to conduct definitive field trials to fill this knowledge gap. The primary aim of this study is to evaluate whether antenatal point-of-care testing and immediate treatment of these curable sexually transmitted and genital infections (STIs) leads to reduction in preterm birth and low birth weight. Methods : The Women and Newborn Trial of Antenatal Interventions and Management (WANTAIM) is a cluster-randomised crossover trial in Papua New Guinea to compare point-of-care STI testing and immediate treatment with standard antenatal care (which includes the WHO-endorsed STI ‘syndromic’ management strategy based on clinical features alone without laboratory confirmation). The unit of randomisation is a primary health care facility and its catchment communities. The primary outcome is a composite measure of two events: the proportion of women and their newborns in each trial arm, who experience either preterm birth (delivery <37 completed weeks of gestation as determined by ultrasound) and/or low birth weight (<2500 g measured within 72 hours of birth). The trial will also evaluate neonatal outcomes, as well as the cost-effectiveness, acceptability and health system requirements of this strategy, compared with standard care. Conclusions: WANTAIM is the first randomised trial to evaluate the effectiveness, cost-effectiveness, acceptability and health system requirements of point-of-care STI testing and treatment to improve birth outcomes in high-burden settings. If the intervention is proven to have an impact, the trial will hasten access to these technologies and could improve maternal and neonatal health in high-burden settings worldwide. Registration: ISRCTN37134032 .
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ItemEstimating the burden of illness related to genital warts in the Philippines: a nationally representative cross-sectional study(BMC, 2019-10-07)BACKGROUND: This study estimated genital warts prevalence, genital-warts-related healthcare resource use and costs, and self-reported human-papillomavirus-related psychosocial impact among male and female patients aged 18-60 years in the Philippines. METHODS: Prevalence was estimated using daily logs numbering genital warts patients treated by participating physicians in 4 Philippine regions over a 5-week period (09JUL2011-24SEP2012). Physicians also completed a survey assessing patient referral patterns, healthcare resource use, treatment, and follow-up care. Psychosocial impact was estimated using the human papillomavirus impact profile and the EQ-5D questionnaires. HIP and EQ-5D scores were compared according to the presence of GW (males) and HPV disease (females). CECA scores were also compared by gender and age groups. RESULTS: Overall genital warts prevalence was estimated at 4.78% (95% confidence interval [CI]: 4.58-4.98%) for men and women aged 18-60 years. Genital warts prevalence was 3.39% (95% CI: 3.13-3.65%) and 8.0% (95% CI: 7.69-8.31%) among women and men, respectively. Prevalence estimates were highest in infectious disease specialist practices 18.67% (95% CI: 18.66-18.69%). Two thirds of the 233 (69.14%) male and 166 (67.20%) female patients were newly-diagnosed genital warts cases. Median costs for genital warts diagnosis and treatment reached 7121 and 7000 Philippine pesos among men and women, respectively. In the Cuestionario Específico para Condiloma Acuminado questionnaire, no statistically significant differences between patients were observed. In the EQ-5D questionnaire, male genital warts patients reported lower mean visual analogue scale scores than those without genital warts (78.20 vs 86.34, p < 0.0001). Mean visual analogue scale score values and utility values were lower for women with human-papillomavirus-related diseases than those without (77.98 vs 78.93, and 0.84 vs 0.88, respectively). CONCLUSIONS: Genital warts is prevalent in the Philippines; more than 60% of cases were newly diagnosed, contributing to high genital-warts-related healthcare resource costs. Diagnosis of genital warts and human papillomavirus negatively impacted psychosocial indices such as patient well-being and health-related quality of life.
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ItemSymptoms, Sites, and Significance of Mycoplasma genitalium in Men Who Have Sex with Men(CENTERS DISEASE CONTROL & PREVENTION, 2019-04)During 2016-2017, we tested asymptomatic men who have sex with men (MSM) in Melbourne, Australia, for Mycoplasma genitalium and macrolide resistance mutations in urine and anorectal swab specimens by using PCR. We compared M. genitalium detection rates for those asymptomatic men to those for MSM with proctitis and nongonococcal urethritis (NGU) over the same period. Of 1,001 asymptomatic MSM, 95 had M. genitalium; 84.2% were macrolide resistant, and 17% were co-infected with Neisseria gonorrhoeae or Chlamydia trachomatis. Rectal positivity for M. genitalium was 7.0% and urine positivity was 2.7%. M. genitalium was not more commonly detected in the rectums of MSM (n = 355, 5.6%) with symptoms of proctitis over the same period but was more commonly detected in MSM (n = 1,019, 8.1%) with NGU. M. genitalium is common and predominantly macrolide-resistant in asymptomatic MSM. M. genitalium is not associated with proctitis in this population.
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ItemCross-sectional study estimating the psychosocial impact of genital warts and other anogenital diseases in South Korea(BMJ PUBLISHING GROUP, 2019-06)OBJECTIVES: To estimate self-reported human papillomavirus (HPV) disease-related psychosocial impact among male and female patients in South Korea. DESIGN: In this multicentre cross-sectional study, psychosocial impacts were estimated using a one-time survey capturing HPV Impact Profile (HIP) results, CuestionarioEspecifico en Condilomas Acuminados (CECA; in Spanish)-'Specific questionnaire for Condylomata Acuminata' and the EuroQol-5 Dimension (EQ-5D) surveys. Student's t-tests or Mann-Whitney U tests were used for continuous comparisons; χ2 or Fisher's exact tests were applied for categorical comparisons. SETTING: 5098 clinics throughout Seoul, Busan, Daegu, Kwangju and Daejeon (South Korea). PARTICIPANTS: Patients with and without genital warts (GW) (males) and selected HPV diseases (females) visiting primary care physicians, obstetricians/gynaecologists, urologists and dermatologists with 2-30 years experience. RESULTS: Of 150 male and 250 female patients, HIP scores showed 85.3% of male patients with GW and 32.0% without reported moderate psychological impact (p<0.0001). In categorised total scores, 88.5% of female patients with and 66.0% without selected HPV-related diseases reported moderate or high psychological impacts (p=0.0004). In the CECA questionnaire, male patients had mean (SD) scores of 10.51 (3.79) in 'emotional health' and 15.90 (6.13) in 'sexual activity'. Female patients with GW reported lower scores in both dimensions with mean scores of 7.18 (4.17) in 'emotional health' and 10.97 (5.80) in 'sexual activity' (p<0.0001), indicating worse health-related quality of life (HRQoL). For the EQ-5D, male patients with GW reported lower mean Visual Analogue Scale (VAS) scores than those without (75.1 vs 81.13, p<0.0135). Mean VAS score and utility values were lower for females with HPV-related diseases than those without (72.18 vs 76.86 and 0.90 vs 0.94, respectively). CONCLUSION: In South Korea, GW in men and HPV-related diseases in women negatively impact patient well-being and HRQoL scores. Among women, those with GW suffered a greater psychosocial impact than those with other selected HPV-related diseases.
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ItemOutcomes of Resistance-guided Sequential Treatment of Mycoplasma genitalium Infections: A Prospective Evaluation(OXFORD UNIV PRESS INC, 2019-02-15)BACKGROUND: Rising macrolide and quinolone resistance in Mycoplasma genitalium necessitate new treatment approaches. We evaluated outcomes of sequential antimicrobial therapy for M. genitalium guided by a macrolide-resistance assay. METHODS: In mid-2016, Melbourne Sexual Health Centre switched from azithromycin to doxycycline (100 mg twice daily for 7 days) for nongonococcal urethritis, cervicitis, and proctitis. Cases were tested for M. genitalium and macrolide-resistance mutations (MRMs) by polymerase chain reaction. Directly after doxycycline, MRM-negative infections received 2.5 g azithromycin (1 g, then 500 mg daily for 3 days), and MRM-positive infections received sitafloxacin (100 mg twice daily for 7 days). Assessment of test of cure and reinfection risk occurred 14-90 days after the second antibiotic. RESULTS: Of 244 evaluable M. genitalium infections (52 women, 68 heterosexual men, 124 men who have sex with men) diagnosed from 20 June 2016 to 15 May 2017, MRMs were detected in 167 (68.4% [95% confidence interval {CI}, 62.2%-74.2%]). Treatment with doxycycline decreased bacterial load by a mean 2.60 log10 (n = 56; P < .0001). Microbiologic cure occurred in 73 of 77 MRM-negative infections (94.8% [95% CI, 87.2%-98.6%]) and in 154 of 167 MRM-positive infections (92.2% [95% CI, 87.1%-95.8%]). Selection of macrolide resistance occurred in only 2 of 76 (2.6% [95% CI, .3%-9.2%]) macrolide-susceptible infections. CONCLUSIONS: In the context of high levels of antimicrobial resistance, switching from azithromycin to doxycycline for presumptive treatment of M. genitalium, followed by resistance-guided therapy, cured ≥92% of infections, with infrequent selection of macrolide resistance.
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ItemImpact of extreme prematurity or extreme low birth weight on young adult health and well-being: the Victorian Infant Collaborative Study (VICS) 1991-1992 Longitudinal Cohort study protocol(BMJ PUBLISHING GROUP, 2019-05)INTRODUCTION: Infants born extremely preterm (EP, <28 weeks' gestation) or with extremely low birth weight (ELBW,<1000 g) in the era when surfactant has been available clinically are at high risk of health and developmental problems in childhood and adolescence. However, how their health and well-being may be affected in adulthood is not well known. This study aims to compare between EP/ELBW and normal birthweight (NBW) controls: (1) physical health, mental health and socioemotional functioning at 25 years of age and (2) trajectories of these outcomes from childhood to adulthood. In addition, this study aims to identify risk factors in pregnancy, infancy, childhood and adolescence for poor physical health and well-being in EP/ELBW young adults. METHODS AND ANALYSIS: The Victorian Infant Collaborative Study (VICS) is a prospective geographical cohort of all EP/ELBW survivors to 18 years of age born in the State of Victoria, Australia, from 1 January 1991 to 31 December 1992 (n=297) and contemporaneous term-born/NBW controls (n=262). Participants were recruited at birth and followed up at 2, 5, 8 and 18 years. This 25-year follow-up includes assessments of physical health (cardiovascular, respiratory and musculoskeletal), mental health and socioemotional functioning. Outcomes will be compared between the birth groups using linear and logistic regression, fitted using generalised estimating equations (GEEs). Trajectories of health outcomes from early childhood will be compared between the birth groups using linear mixed-effects models. Risk factors for adult outcomes will be assessed using linear and logistic regression (fitted using GEEs). ETHICS AND DISSEMINATION: This study was approved by the Human Research Ethics Committees of the Royal Women's Hospital, Mercy Hospital for Women, Monash Medical Centre and the Royal Children's Hospital, Melbourne. Study outcomes will be disseminated through conference presentations, peer-reviewed publications, the internet and social media.