Obstetrics and Gynaecology - Research Publications

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    Opportunities for improving hypertensive disorders of pregnancy (HDP) management in primary care settings: A review of international published guidelines in the context of pregnancy care in Indonesia
    Ekawati, FM ; Emilia, O ; Brennecke, S ; Gunn, J ; Licqurish, S ; Lau, P (Elsevier, 2020-01-01)
    Almost all of global maternal mortality caused by HDP occurs in low to middle-income countries (LMIC). However, limited guidance is available to local primary care practitioners who are usually the main health care providers. This review examined existing international practice guidelines to identify potential practices to improve HDP management in Indonesian primary care settings. We performed structured literature search strategies and snowballing searches in six databases (MEDLINE, Web of Science, EMBASE, CINAHL, Cochrane reviews and Google Scholar) for guidelines that were published between 2007 and 2018 using relevant keywords and phrases of ‘guidelines’, ‘hypertensive disorders of pregnancy’ or ‘preeclampsia’ and ‘primary care’. The AGREE II instrument was used to assess quality and reporting of the eligible guidelines. Thematic analysis was performed on all of the guidelines and the results were discussed among the project investigators. Sixteen international practice guidelines or similar management recommendations were reviewed. Almost all of them were partially applicable, with some managements potentially able to be adopted to Indonesian primary care settings. Three main themes for improving HDP management were identified, namely clinical management, care planning, and professional communication. These potential improvements in managing women with HDP in Indonesia may also be relevant in other LMIC. Further contextualisation is required to facilitate their adoption in practice settings.
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    Hypertensive disorders of pregnancy (HDP) management pathways: results of a Delphi survey to contextualise international recommendations for Indonesian primary care settings
    Ekawati, FM ; Licqurish, S ; Gunn, J ; Brennecke, S ; Lau, P (BMC, 2021-04-01)
    BACKGROUND: Hypertensive disorders of pregnancy (HDP) are a significant contributor to the high maternal mortality rate in Indonesia. At the moment, limited guidelines are available to assist primary care providers in managing HDP cases. A previous review of 16 international HDP guidelines has identified opportunities for improving HDP management in Indonesian primary care, but it has not determined the suitability of the recommendations in practice. This study aims to achieve consensus among the experts regarding the recommendations suitability and to develop HDP pathways in Indonesian primary care. METHODS: Maternal health experts, including GPs, midwives, nurses, medical specialists and health policy researchers from Indonesia and overseas were recruited for the study. They participated in a consensus development process that applied a mix of quantitative and qualitative questions in three Delphi survey rounds. At the first and second-round survey, the participants were asked to rate their agreement on whether each of 125 statements about HDP and HDP management is appropriate for use in Indonesian primary care settings. The third-round survey presented the drafts of HDP pathways and sought participants' agreement and further suggestions. The participants' agreement scores were calculated with a statement needing a minimum of 70% agreement to be included in the HDP pathways. The participants' responses and suggestions to the free text questions were analysed thematically. RESULTS: A total of 52 participants were included, with 48, 45 and 37 of them completing the first, second and third round of the survey respectively. Consensus was reached for 115 of the 125 statements on HDP definition, screening, management and long-term follow-up. Agreement scores for the statements ranged from 70.8-100.0%, and potential implementation barriers of the pathways were identified. Drafts of HDP management pathways were also agreed upon and received suggestions from the participants. CONCLUSIONS: Most evidence-based management recommendations achieved consensus and were included in the developed HDP management pathways, which can potentially be implemented in Indonesian settings. Further investigations are needed to explore the acceptability and feasibility of the developed HDP pathways in primary care practice.
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    Patients' preferences for involvement in treatment decision making in Japan.
    Sekimoto, M ; Asai, A ; Ohnishi, M ; Nishigaki, E ; Fukui, T ; Shimbo, T ; Imanaka, Y (Springer Science and Business Media LLC, 2004-03-01)
    BACKGROUND: A number of previous studies have suggested that the Japanese have few opportunities to participate in medical decision-making, as a result both of entrenched physician paternalism and national characteristics of dependency and passivity. The hypothesis that Japanese patients would wish to participate in treatment decision-making if adequate information were provided, and the decision to be made was clearly identified, was tested by interview survey. METHODS: The subjects were diabetic patients at a single outpatient clinic in Kyoto. One of three case study vignettes (pneumonia, gangrene or cancer) was randomly assigned to each subject and, employing face-to-face interviews, the subjects were asked what their wishes would be as patients, for treatment information, participation in decision-making and family involvement. RESULTS: 134 patients participated in the study, representing a response rate of 90%. The overall proportions of respondents who preferred active, collaborative, and passive roles were 12%, 71%, and 17%, respectively. Respondents to the cancer vignette were less likely to prefer an active role and were more likely to prefer family involvement in decision-making compared to non-cancer vignette respondents. If a physician's recommendation conflicted with their own wishes, 60% of the respondents for each vignette answered that they would choose to respect the physician's opinion, while few respondents would give the family's preference primary importance. CONCLUSIONS: Our study suggested that a majority of Japanese patients have positive attitudes towards participation in medical decision making if they are fully informed. Physicians will give greater patient satisfaction if they respond to the desire of patients for participation in decision-making.
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    The PAV trial: does lactobacillus prevent post-antibiotic vulvovaginal candidiasis? Protocol of a randomised controlled trial [ISRCTN24141277].
    Pirotta, M ; Gunn, J ; Chondros, P ; Grover, S ; Hurley, S ; Garland, S (Springer Science and Business Media LLC, 2004-03-28)
    BACKGROUND: Complementary and alternative medicines are used by many consumers, and increasingly are being incorporated into the general practitioner's armamentarium. Despite widespread usage, the evidence base for most complementary therapies is weak or non-existent. Post-antibiotic vulvovaginitis is a common problem in general practice, for which complementary therapies are often used. A recent study in Melbourne, Australia, found that 40% of women with a past history of vulvovaginitis had used probiotic Lactobacillus species to prevent or treat post-antibiotic vulvovaginitis. There is no evidence that this therapy is effective. This study aims to test whether oral or vaginal lactobacillus is effective in the prevention of post-antibiotic vulvovaginitis. METHODS/DESIGN: A randomised placebo-controlled blinded 2 x 2 factorial design is being used. General practitioners or pharmacists approach non-pregnant women, aged 18-50 years, who present with a non-genital infection requiring a short course of oral antibiotics, to participate in the study. Participants are randomised in a four group factorial design either to oral lactobacillus powder or placebo and either vaginal lactobacillus pessaries or placebo. These interventions are taken while on antibiotics and for four days afterwards or until symptoms of vaginitis develop. Women self collect a vaginal swab for culture of Candida species and complete a survey at baseline and again four days after completing their study medications. The sample size (a total of 496--124 in each factorial group) is calculated to identify a reduction of half in post-antibiotic vulvovaginitis from 23%, while allowing for a 25% drop-out. An independent Data Monitoring Committee is supervising the trial. Analysis will be intention-to-treat, with two pre-specified main comparisons: (i) oral lactobacillus versus placebo and (ii) vaginal lactobacillus versus placebo.
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    Chlamydia trachomatis Incidence and Re-Infection among Young Women - Behavioural and Microbiological Characteristics
    Walker, J ; Tabrizi, SN ; Fairley, CK ; Chen, MY ; Bradshaw, CS ; Twin, J ; Taylor, N ; Donovan, B ; Kaldor, JM ; McNamee, K ; Urban, E ; Walker, S ; Currie, M ; Birden, H ; Bowden, F ; Gunn, J ; Pirotta, M ; Gurrin, L ; Harindra, V ; Garland, SM ; Hocking, JS ; Ojcius, DM (PUBLIC LIBRARY SCIENCE, 2012-05-25)
    BACKGROUND: This study aimed to estimate rates of chlamydia incidence and re-infection and to investigate the dynamics of chlamydia organism load in prevalent, incident and re-infections among young Australian women. METHODS: 1,116 women aged 16 to 25 years were recruited from primary care clinics in Australia. Vaginal swabs were collected at 3 to 6 month intervals for chlamydia testing. Chlamydia organism load was measured by quantitative PCR. RESULTS: There were 47 incident cases of chlamydia diagnosed and 1,056.34 person years of follow up with a rate of 4.4 per 100 person years (95% CI: 3.3, 5.9). Incident infection was associated with being aged 16 to 20 years [RR = 3.7 (95%CI: 1.9, 7.1)], being employed [RR = 2.4 (95%CI: 1.1, 4.9)] and having two or more new sex partners [RR = 5.5 (95%CI: 2.6, 11.7)]. Recent antibiotic use was associated with a reduced incidence [RR:0.1 (95%CI: 0.0, 0.5)]. There were 14 re-infections with a rate of 22.3 per 100 person years (95%CI: 13.2, 37.6). The median time to re-infection was 4.6 months. Organism load was higher for prevalent than incident infections (p<0.01) and for prevalent than re-infections (p<0.01). CONCLUSIONS: Chlamydia is common among young women and a high proportion of women are re-infected within a short period of time, highlighting the need for effective partner treatment and repeat testing. The difference in organism load between prevalent and incident infections suggests prevalent infection may be more important for ongoing transmission of chlamydia.
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    'The difference in determinants of Chlamydia trachomatis and Mycoplasma genitalium in a sample of young Australian women'
    Walker, J ; Fairley, CK ; Bradshaw, CS ; Tabrizi, SN ; Chen, MY ; Twin, J ; Taylor, N ; Donovan, B ; Kaldor, JK ; McNamee, K ; Urban, E ; Walker, S ; Currie, M ; Birden, H ; Bowden, F ; Gunn, J ; Pirotta, M ; Gurrin, L ; Harindra, V ; Garland, S ; Hocking, JS (BIOMED CENTRAL LTD, 2011-02-01)
    BACKGROUND: Differences in the determinants of Chlamydia trachomatis ('chlamydia') and Mycoplasma genitalium (MG) genital infection in women are not well understood. METHODS: A cohort study of 16 to 25 year old Australian women recruited from primary health care clinics, aimed to determine chlamydia and MG prevalence and incidence. Vaginal swabs collected at recruitment were used to measure chlamydia and MG prevalence, organism-load and chlamydia-serovar a cross-sectional analysis undertaken on the baseline results is presented here. RESULTS: Of 1116 participants, chlamydia prevalence was 4.9% (95% CI: 2.9, 7.0) (n = 55) and MG prevalence was 2.4% (95% CI: 1.5, 3.3) (n = 27). Differences in the determinants were found - chlamydia not MG, was associated with younger age [AOR:0.9 (95% CI: 0.8, 1.0)] and recent antibiotic use [AOR:0.4 (95% CI: 0.2, 1.0)], and MG not chlamydia was associated with symptoms [AOR:2.1 (95% CI: 1.1, 4.0)]. Having two or more partners in last 12 months was more strongly associated with chlamydia [AOR:6.4 (95% CI: 3.6, 11.3)] than MG [AOR:2.2 (95% CI: 1.0, 4.6)] but unprotected sex with three or more partners was less strongly associated with chlamydia [AOR:3.1 (95%CI: 1.0, 9.5)] than MG [AOR:16.6 (95%CI: 2.0, 138.0)]. Median organism load for MG was 100 times lower (5.7 × 104/swab) than chlamydia (5.6 × 106/swab) (p < 0.01) and not associated with age or symptoms for chlamydia or MG. CONCLUSIONS: These results demonstrate significant chlamydia and MG prevalence in Australian women, and suggest that the differences in strengths of association between numbers of sexual partners and unprotected sex and chlamydia and MG might be due to differences in the transmission dynamics between these infections.
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    Maximising retention in a longitudinal study of genital Chlamydia trachomatis among young women in Australia
    Walker, J ; Fairley, CK ; Urban, E ; Chen, MY ; Bradshaw, C ; Walker, SM ; Donovan, B ; Tabrizi, SN ; McNamee, K ; Currie, M ; Pirotta, M ; Kaldor, J ; Gurrin, LC ; Birden, H ; Harindra, V ; Bowden, FJ ; Garland, S ; Gunn, JM ; Hocking, JS (BIOMED CENTRAL LTD, 2011-03-09)
    BACKGROUND: Cohort studies are an important study design however they are difficult to implement, often suffer from poor retention, low participation and bias. The aims of this paper are to describe the methods used to recruit and retain young women in a longitudinal study and to explore factors associated with loss to follow up. METHODS: The Chlamydia Incidence and Re-infection Rates Study (CIRIS) was a longitudinal study of Australian women aged 16 to 25 years recruited from primary health care clinics. They were followed up via the post at three-monthly intervals and required to return questionnaires and self collected vaginal swabs for chlamydia testing. The protocol was designed to maximise retention in the study and included using recruiting staff independent of the clinic staff, recruiting in private, regular communication with study staff, making the follow up as straightforward as possible and providing incentives and small gifts to engender good will. RESULTS: The study recruited 66% of eligible women. Despite the nature of the study (sexual health) and the mobility of the women (35% moved address at least once), 79% of the women completed the final stage of the study after 12 months. Loss to follow up bias was associated with lower education level [adjusted hazard ratio (AHR): 0.7 (95% Confidence Interval (CI): 0.5, 1.0)], recruitment from a sexual health centre as opposed to a general practice clinic [AHR: 1.6 (95% CI: 1.0, 2.7)] and previously testing positive for chlamydia [AHR: 0.8 (95% CI: 0.5, 1.0)]. No other factors such as age, numbers of sexual partners were associated with loss to follow up. CONCLUSIONS: The methods used were considered effective for recruiting and retaining women in the study. Further research is needed to improve participation from less well-educated women.
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    Developing management pathways for hypertensive disorders of pregnancy (HDP) in Indonesian primary care: a study protocol
    Ekawati, FM ; Licqurish, S ; Emilia, O ; Gunn, J ; Brennecke, S ; Lau, P (BMC, 2019-02-01)
    Background National and international guidelines for the management of hypertensive disorders of pregnancy (HDP) are available in developing countries. However, more detailed clinical pathways for primary care settings are limited. This study focuses on Indonesia, where 72% of women who died from HDP and its complications had received less appropriate treatment according to international guidelines. There is an urgent need to develop primary care focused pathways that enable general practitioners (GPs), midwives and other relevant providers to manage HDP better. Objectives This paper describes a study protocol for the development of HDP management pathways for Indonesian primary care settings. Methods This study design is informed by Implementation Science theories and consists of three phases. The exploratory phase will involve conducting semi-structured interviews with key Indonesian primary care stakeholders to explore their experiences and views on HDP management. The development phase will apply evidence from the literature review and results of the exploratory phase to develop HDP management pathways contextualised to Indonesian primary care settings. Consensus will be sought from approximately 50 experts, consist of general practitioners (GPs), midwives, obstetricians, nurses and policy makers using Delphi technique survey. The evaluation phase will involve a pilot study to evaluate the pathways’ acceptability and feasibility in a sample of Indonesian primary care practices using mixed methods. Discussion The implementation science frameworks inform and guide the phases in this study. Qualitative interviews in the exploratory phase are conducive to eliciting opinions from key stakeholders. Using Delphi technique at the development phase is suitable to seek participants’ consensus on HDP management in primary care. Observations, focus group discussions, interviews as well as analysis of patients’ medical records at the evaluation phase are expected to provide a comprehensive investigation of the implementation of the pathways in practice settings.
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    Maternal health study: a prospective cohort study of nulliparous women recruited in early pregnancy.
    Brown, SJ ; Lumley, JM ; McDonald, EA ; Krastev, AH ; Maternal Health Study collaborative group, (Springer Science and Business Media LLC, 2006-04-11)
    BACKGROUND: In the first year after childbirth, 94% of women experience one or more major health problems (urinary incontinence, faecal incontinence, perineal pain, back pain). Difficulties in intimate partner relationships and changes affecting sexual health are also common. The aim of this study is to investigate changes in women's health from early pregnancy until four years after the birth of a first child. METHODS/DESIGN: The Maternal Health Study is a longitudinal study designed to fill in some of the gaps in current research evidence regarding women's physical and psychological health and recovery after childbirth. A prospective pregnancy cohort of >1500 nulliparous women has been recruited in early pregnancy at six metropolitan public hospitals in Melbourne, Australia between April 2003 and December 2005. In the first phase of the study participants are being followed up at 30-32 weeks gestation in pregnancy, and at three, six, nine, 12 and 18 months postpartum using a combination of self-administered questionnaires and telephone interviews. Women consenting to extended follow-up (phase 2) will be followed up six and 12 months after any subsequent births and when their first child is four years old. Study instruments incorporate assessment of the frequency and severity of urinary and bowel symptoms, sexual health issues, perineal and abdominal pain, depression and intimate partner violence. Pregnancy and birth outcome data will be obtained by review of hospital case notes. DISCUSSION: Features of the study which distinguish it from prior research include: the capacity to identify incident cases of morbidity and clustering of health problems; a large enough sample to detect clinically important differences in maternal health outcomes associated with the method of birth; careful exposure measurement involving manual abstraction of data from medical records in order to explore mediating factors and possible causal pathways; and use of a variety of strategies to improve ascertainment of health outcomes.
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    Effect of lactobacillus in preventing post-antibiotic vulvovaginal candidiasis: a randomised controlled trial
    Pirotta, M ; Gunn, J ; Chondros, P ; Grover, S ; O'Malley, P ; Hurley, S ; Garland, S (B M J PUBLISHING GROUP, 2004-09-04)
    OBJECTIVE: To test whether oral or vaginal lactobacillus can prevent vulvovaginitis after antibiotic treatment. DESIGN: Randomised, placebo controlled, double blind, factorial 2x2 trial. SETTING: Fifty general practices and 16 pharmacies in Melbourne, Australia. PARTICIPANTS: Non-pregnant women aged 18-50 years who required a short course of oral antibiotics for a non-gynaecological infection: 278 were enrolled in the study, and results were available for 235. INTERVENTIONS: Lactobacillus preparations taken orally or vaginally, or both, from enrollment until four days after completion of their antibiotic course. MAIN OUTCOME MEASURES: Participants' reports of symptoms of post-antibiotic vulvovaginitis, with microbiological evidence of candidiasis provided by a self obtained vaginal swab. RESULTS: Overall, 55/235 (23% (95% confidence interval 18% to 29%)) women developed post-antibiotic vulvovaginitis. Compared with placebo, the odds ratio for developing post-antibiotic vulvovaginitis with oral lactobacillus was 1.06 (95% confidence interval 0.58 to 1.94) and with vaginal lactobacillus 1.38 (0.75 to 2.54). Compliance with antibiotics and interventions was high. The trial was terminated after the second interim analysis because of lack of effect of the interventions. Given the data at this time, the chances of detecting a significant reduction in vulvovaginitis with oral or vaginal lactobacillus treatment were less than 0.032 and 0.0006 respectively if the trial proceeded to full enrollment. CONCLUSIONS: The use of oral or vaginal forms of lactobacillus to prevent post-antibiotic vulvovaginitis is not supported by these results. Further research on this subject is unlikely to be fruitful, unless new understandings about the pathogenesis of post-antibiotic vulvovaginitis indicate a possible role for lactobacillus.