Obstetrics and Gynaecology - Research Publications
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ItemLong-term trends of Chlamydia trachomatis in a clinic population at the Royal Women's Hospital, Melbourne(WILEY, 2020-02)BACKGROUND: Chlamydia trachomatis (C. trachomatis) prevalence has been reported to be increasing. Whether this is a true increase over time or confounded by increases in testing and/or use of more sensitive assays is to be determined. MATERIALS AND METHODS: One laboratory service has been detecting C. trachomatis for the past 30 years within the Royal Women's Hospital Melbourne. We conducted a retrospective audit of records over the period 1986-2016 from a clinic population routinely offered chlamydia screening. These were women presenting for family planning advice (termination of pregnancy, intrauterine device insertion or considered at high risk), who underwent chlamydia testing in the context of various diagnostic assays used over this time period. Assays utilised included culture, enzyme immunoassay (EIA), DNA probe, and nucleic acid amplification testing (NAAT). Non-parametric test for trend was used to determine significant differences between prevalence estimates across ordered groups. Least squares regression was conducted to describe a linear trend matching known data points. RESULTS: Overall, there was no significant change for chlamydia prevalence which was 2.2%, in the 30-year study period (P = 0.7). Over time diagnostic assays changed from culture, to EIA, DNA probe, to the more sensitive NAAT. The bulk of the positives were in women under 25 years of age (57%). CONCLUSION: Chlamydia prevalence has been stable over 30 years, remaining a problem in young women. Screening for those at risk needs underscoring in a national sexual health program.
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ItemPostnatal probiotics and allergic disease in very preterm infants: Sub-study to the ProPrems randomized trial(WILEY, 2020-01)BACKGROUND: Probiotic supplementation to mothers and/or their term-born infants has been suggested to prevent allergic disease, in particular eczema; however, no studies have investigated probiotics for prevention of allergic diseases in very preterm infants. We evaluated the effect of a postnatal probiotic combination on development of allergic diseases in very preterm infants. METHODS: This sub-study was an a priori secondary outcome of the ProPrems multi-center, double-blind, placebo-controlled randomized trial (ANZCTR:12607000144415). ProPrems randomized 1099 very preterm infants to receive a probiotic combination or placebo from soon after birth until discharge from hospital or term corrected age (CA), whichever was earlier. Allergic disease (eczema, atopic eczema, food allergy, wheeze, atopic sensitization) was assessed in a subgroup of ProPrems infants (n = 281) as close to 12 months CA as possible by questionnaire, clinical examination, and skin prick tests to common allergens. RESULTS: There was no difference in eczema incidence between the probiotic and placebo groups (35[30%] of 118 infants vs 37[27%] of 137 infants, respectively, absolute difference 2.65%, 95% CI -8.45 to 13.75). Similarly, the incidence of atopic eczema (6[5%] of 118 vs 3[2%] of 137), food allergy (4[3%] of 124 vs 2[1%] of 154), wheeze (39[31%] of 127 vs 45[29%] of 154), and atopic sensitization (14[13%] of 106 vs 13[11%] of 123) were similar between the probiotic and placebo groups. CONCLUSION: This study found no effect of postnatal administration of a probiotic combination on the incidence of allergic diseases or atopic sensitization in the first 2 years of life in children born very preterm. Evidence that probiotics are effective for prevention of allergic disease in premature infants remains lacking; adequately powered randomized controlled trials evaluating probiotic supplementation for allergy prevention in very preterm infants are needed.
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ItemDetection of high-grade cervical disease among women referred directly to colposcopy after a positiveHPVscreening test varies with age and cytology findings(WILEY, 2020-12-01)Australia's new HPV-based cervical screening program is based on an algorithm that incorporates reflex cytology to guide decisions about further follow-up with colposcopy and, if indicated, biopsy. We reviewed results for 2300 women referred directly for colposcopy after their first positive HPV screening test, to determine the proportion that had underlying histological high-grade abnormality (HGA). Overall, HGA was detected in 24.3% of women. Among HPV16/18 positive women, 18.0% had HGA, increasing from 6.6% among women with negative cytology to 79.7% among women with high-grade squamous lesion or worse, or any glandular lesion on cytology (HSIL+; P-trend < .001). For this latter group, the proportion with HGA was higher among HPV16/18 positive women than among those positive for other oncogenic types (68.8%; P = .029). Among women with ASC-H cytology, 51.8% had HGA, with no difference between HPV groups (P = .314). In analyses by age-groups, detection of HGA was highest, at 36.4%, among women younger than 35 years, then decreased significantly to 5.9%, among women aged 65 to 74 years (P-trend < .001). The relationship of decreasing HGA detection with increasing age was strong for women with negative cytology, and those with ASC-H cytology (P-trend < .001 for each). For women with HSIL+ cytology, detection of HGA was high and stable, regardless of age (P-trend = .211). This report describes the first follow-up colposcopy findings in Australia's new HPV-based cervical screening program. The results demonstrate the additional value of reflex cytology in managing HPV positive women and suggest that further refinement of the risk-based algorithm to account for age may be warranted.
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ItemNo Preview AvailablehTERT Protein Expression in Cytoplasm and Nucleus and its Association With HPV Infection in Patients With Cervical Cancer(INT INST ANTICANCER RESEARCH, 2020)BACKGROUND: Few studies have analyzed the association between human telomerase reverse transcriptase (hTERT) protein expression (nuclear and cytoplasmic localization), hTERT methylation status, and human papillomavirus (HPV) genotype infection in cervical cancer. PATIENTS AND METHODS: One hundred seventy-three patients with cervical cancer were analyzed. hTERT protein expression was detected by immunohistochemistry. hTERT DNA methylation analysis was performed using a PCR-RLB-hTERT assay, targeting two regions of the hTERT promoter. Type specific HPV infection was detected by using GP5+/GP6+PCR-RLB. RESULTS: hTERT protein expression was found in both cytoplasm and nucleus (78.0% of the samples showed a cytoplasmic localization and 79.8% had a nuclear localization). A statistically significant association was found between alpha 9 and 7 HPV species with a non-methylation pattern of the hTERT promoter and between these species and high expression of hTERT protein with nuclear localization. CONCLUSION: hTERT protein is found in both the nucleus and cytoplasm of patients with cervical cancer and confirm the relationship between the non-methylated status of hTERT promoter and some HPV species as well as the relationship between these species and hTERT protein expression.
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ItemMeasurement of Human Papillomavirus-Specific Antibodies Using a Pseudovirion-Based ELISA Method(FRONTIERS MEDIA SA, 2020-10-28)Human papillomavirus (HPV) vaccines are safe and effective in preventing HPV infection and cervical precancers. Neutralizing antibodies are thought to be the primary mechanism of protection for HPV vaccines, although the exact level required for protection has not been identified. Three common serological assays used in clinical trials to measure HPV antibodies are HPV pseudovirion-based neutralization assay (PBNA), competitive or total Luminex immunoassays (cLIA or LIA) and VLP-based enzyme linked immunosorbent assays (ELISA). While PBNA is the gold-standard for measuring neutralizing antibodies (NAb), it is labor intensive. Luminex immunoassay and VLP-ELISA are rapid and high throughput, but their reagents and equipment can be difficult to source. Nevertheless, data generated from these assays generally correlate well with PBNA. Here, we described a simplified high-throughput PsV-based ELISA for HPV antibody measurement, to circumvent some of the limitations of existing assays. Using this assay, we were able to differentiate HPV-specific IgG and IgM, and found a strong correlation between HPV-specific IgG and NAb levels, as previously determined by PBNA. This assay platform is simpler and less time-consuming than PBNA. In addition, the materials can be readily produced and obtained commercially. This assay can be used as an alternative method to measure HPV antibodies.
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ItemTreating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence(BMC, 2020-11-11)BACKGROUND: Bacterial vaginosis (BV) is estimated to affect 1 in 3 women globally and is associated with obstetric and gynaecological sequelae. Current recommended therapies have good short-term efficacy but 1 in 2 women experience BV recurrence within 6 months of treatment. Evidence of male carriage of BV-organisms suggests that male partners may be reinfecting women with BV-associated bacteria (henceforth referred to as BV-organisms) and impacting on the efficacy of treatment approaches solely directed to women. This trial aims to determine the effect of concurrent male partner treatment for preventing BV recurrence compared to current standard of care. METHODS: StepUp is an open-label, multicentre, parallel group randomised controlled trial for women diagnosed with BV and their male partner. Women with clinical-BV defined using current gold standard diagnosis methods (≥3 Amsel criteria and Nugent score (NS) = 4-10) and with a regular male partner will be assessed for eligibility, and couples will then be consented. All women will be prescribed oral metronidazole 400 mg twice daily (BID) for 7 days, or if contraindicated, a 7-day regimen of topical vaginal 2% clindamycin. Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID). Couples will be followed for up to 12 weeks to assess BV status in women, and assess the adherence, tolerability and acceptability of male partner treatment. The primary outcome is BV recurrence defined as ≥3 Amsel criteria and NS = 4-10 within 12 weeks of enrolment. The estimated sample size is 342 couples, to detect a 40% reduction in BV recurrence rates from 40% in the control group to 24% in the intervention group within 12 weeks. DISCUSSION: Current treatments directed solely to women result in unacceptably high rates of BV recurrence. If proven to be effective the findings from this trial will directly inform the development of new treatment strategies to impact on BV recurrence. TRIAL REGISTRATION: The trial was prospectively registered on 12 February 2019 on the Australian and New Zealand Clinical Trial Registry (ACTRN12619000196145, Universal Trial Number: U1111-1228-0106, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376883&isReview=true ).
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ItemEstimating the Burden of Illness Related to Genital Warts in Russia: A Cross-Sectional Study.(The Journal of Health Economics and Outcomes Research, 2020)BACKGROUND: Human papillomavirus (HPV) infections are the etiologic agents of genital warts (GW). HPV is one of the most frequent sexually transmitted viral infections, and nearly 65% of individuals with partners who have GW also develop GW. In Russia, as in many other countries, overall GW prevalence data are scarce. Given the lack of Russian data, our study estimated GW prevalence in physician practices and GW-related health care resource use in Russia among male and female patients aged 18-60 years. METHODS: Russian physicians recorded daily patient logs for a two-week period and conducted a 30-minute survey to estimate GW prevalence and related resource use between January and June 2012. Age, gender, and GW diagnosis status was recorded. Prevalence was obtained for each physician and calculated into a single estimate across all physician types. Overall prevalence estimate and 95% confidence interval were weighted by the estimated number of physicians in each specialty and the proportion of total patients visiting each specialist type. Health care resource use was reported and compared among different physician specialties. RESULTS: The overall GW prevalence estimate was 9162 cases per 100 000 for male and female patients aged 18-60 years, with 9917 for obstetrician/gynecologists (OB/GYN), 8298 for urologists (URO), and 7833 for dermatologists (DERM). For males, GW prevalence was 8769 cases per 100 000, with the highest prevalence in the 30-34 age group. In females, GW prevalence was 9304 cases per 100 000, with the highest prevalence in the 18-24 age group. Among overall existing GW cases, 63.1% were recurrent and 34.2% were resistant. For all patients in our study, GW prevalence was higher in females. Male patients had the highest prevalence for those aged 30-34 years, and female patients for those aged 18-24 years. These results are consistent with data reported in other countries. Study limitations include estimates and results representative of the urban population of Russia. Despite its limitations, this study provides a GW prevalence estimate in Russia not previously available. CONCLUSIONS: GW is a significant public health concern in Russia, and the GW prevalence was higher in female patients compared to male patients.
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ItemA significant measure of HPV vaccine effectiveness in a high-risk population in Korea prior to a National Immunization Program(KOREAN SOC GYNECOLOGY ONCOLOGY & COLPOSCOPY, 2020-01)