44 research outputs found

    Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: an open-label pilot randomized controlled trial

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    <p>Abstract</p> <p>Background</p> <p>Although the connection between ascending infection and preterm birth is undisputed, research focused on finding effective treatments has been disappointing. However evidence that eradication of <it>Candida </it>in pregnancy may reduce the risk of preterm birth is emerging. We conducted a pilot study to assess the feasibility of conducting a large randomized controlled trial to determine whether treatment of asymptomatic candidiasis in early pregnancy reduces the incidence of preterm birth.</p> <p>Methods</p> <p>We used a prospective, randomized, open-label, blinded-endpoint (PROBE) study design. Pregnant women presenting at <20 weeks gestation with singleton pregnancies self-collected a vaginal swab. Those who were asymptomatic and culture positive for <it>Candida </it>were randomized to 6-days of clotrimazole vaginal pessaries (100mg) or usual care (screening result is not revealed, no treatment). The primary outcomes were the rate of asymptomatic vaginal candidiasis, participation and follow-up. The proposed primary trial outcome of spontaneous preterm birth <37 weeks gestation was also assessed.</p> <p>Results</p> <p>Of 779 women approached, 500 (64%) participated in candidiasis screening, and 98 (19.6%) had asymptomatic vaginal candidiasis and were randomized to clotrimazole or usual care. Women were not inconvenienced by participation in the study, laboratory testing and medication dispensing were problem-free, and the follow-up rate was 99%. There was a tendency towards a reduction in spontaneous preterm birth among women with asymptomatic candidiasis who were treated with clotrimazole RR = 0.33, 95%CI 0.04-3.03.</p> <p>Conclusions</p> <p>A large, adequately powered, randomized trial of clotrimazole to prevent preterm birth in women with asymptomatic candidiasis is both feasible and warranted.</p> <p>Trial registration</p> <p>Australia and New Zealand Clinical Trials Register (ANZCTR): <a href="http://www.anzctr.org.au/ACTRN12609001052224.aspx">ACTRN12609001052224</a></p

    Protocol for a randomised controlled trial of treatment of asymptomatic candidiasis for the prevention of preterm birth [ACTRN12610000607077]

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    <p>Abstract</p> <p>Background</p> <p>Prevention of preterm birth remains one of the most important challenges in maternity care. We propose a randomised trial with: a simple <it>Candida </it>testing protocol that can be easily incorporated into usual antenatal care; a simple, well accepted, treatment intervention; and assessment of outcomes from validated, routinely-collected, computerised databases.</p> <p>Methods/Design</p> <p>Using a prospective, randomised, open-label, blinded-endpoint (PROBE) study design, we aim to evaluate whether treating women with asymptomatic vaginal candidiasis early in pregnancy is effective in preventing spontaneous preterm birth. Pregnant women presenting for antenatal care <20 weeks gestation with singleton pregnancies are eligible for inclusion. The intervention is a 6-day course of clotrimazole vaginal pessaries (100 mg) and the primary outcome is spontaneous preterm birth <37 weeks gestation.</p> <p>The study protocol draws on the usual antenatal care schedule, has been pilot-tested and the intervention involves only a minor modification of current practice. Women who agree to participate will self-collect a vaginal swab and those who are culture positive for Candida will be randomised (central, telephone) to open-label treatment or usual care (screening result is not revealed, no treatment, routine antenatal care). Outcomes will be obtained from population databases.</p> <p>A sample size of 3,208 women with <it>Candida </it>colonisation (1,604 per arm) is required to detect a 40% reduction in the spontaneous preterm birth rate among women with asymptomatic candidiasis from 5.0% in the control group to 3.0% in women treated with clotrimazole (significance 0.05, power 0.8). Analyses will be by intention to treat.</p> <p>Discussion</p> <p>For our hypothesis, a placebo-controlled trial had major disadvantages: a placebo arm would not represent current clinical practice; knowledge of vaginal colonisation with <it>Candida </it>may change participants' behaviour; and a placebo with an alcohol preservative may have an independent affect on vaginal flora. These disadvantages can be overcome by the PROBE study design.</p> <p>This trial will provide definitive evidence on whether screening for and treating asymptomatic candidiasis in pregnancy significantly reduces the rate of spontaneous preterm birth. If it can be demonstrated that treating asymptomatic candidiasis reduces preterm births this will change current practice and would directly impact the management of every pregnant woman.</p> <p>Trial registration</p> <p>Australian New Zealand Clinical Trials Registry <a href="http://www.anzctr.org.au/ACTRN12610000607077.aspx">ACTRN12610000607077</a></p

    The role of Ureaplasma urealyticum in adverse pregnancy outcome

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    We investigated Ureaplasma urealyticum genital tract colonisation rates in an Australian population to determine whether colonisation was associated with adverse pregnancy outcome. Women attending an antenatal clinic were evaluated for lower genital tract colonisation at their first antenatal visit (162 women) and at 28 weeks gestation (120 women). Placentas from 92 women were cultured. U. urealyticum was the predominant isolate from the lower (57.4%) and upper (17.4%) genital tract in this population of pregnant women. U. urealyticum was a persistent coloniser during mid-trimester of pregnancy (in 88% of women colonised) whereas M. hominis, G. vaginalis, and Group B streptococcus were present as transient flora of the lower genital tract. Lower genital tract colonisation during pregnancy was not directly associated with adverse pregnancy outcome. However preterm delivery in afebrile, asymptomatic women, could possibly be associated with chorioamnionitis (four of 16 preterm births). Screening of women with a history of preterm birth may prevent upper genital tract infections and preterm delivery

    Revisão sistemática e meta-análise da antibioticoprofilaxia na histerectomia abdominal Systematic review and meta-analysis of antibiotic prophylaxis in abdominal hysterectomy

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    O presente estudo objetivou examinar a evidência científica disponível relativa à eficácia da antibioticoprofilaxia no caso da histerectomia, no sentido de subsidiar decisões relativas a financiamento e contribuir para a produção de diretrizes clínicas baseadas em evidências. Usando protocolo previamente elaborado, os ensaios disponíveis foram analisados quanto à pertinência e qualidade. A heterogeneidade clínica dos ensaios selecionados também foi examinada. O teste de heterogeneidade estatística sugeriu que os estudos são homogêneos, considerando-se o valor de p > 0,10 como nível de significância para rejeitar a heterogeneidade. A combinação dos resultados dos 16 ensaios placebo-controlados selecionados resultou em razão de taxas sumárias de 0,49 (IC95%: 0,41-0,59), ou seja, em eficácia de 51%, e em diferença de taxas sumárias de 11% (IC95%: 8-14%), utilizando-se o modelo de efeitos fixos. Os resultados observados usando-se o modelo de efeitos aleatórios foram muito semelhantes. A análise exploratória de esquemas de dose única versus doses múltiplas não indicou maior eficácia para esquemas de doses múltiplas. A evidência disponível, baseando-se em ensaios comparativos, é insuficiente para inferir que existe vantagem em usar cefalosporinas de terceira geração frente àquelas de primeira.<br>The objective of the present study was to assess the available evidence regarding antibiotic prophylaxis taking the case of abdominal hysterectomy, as an aid to decisions related to coverage and to the development of evidence-based clinical guidelines. Using a previously elaborated protocol, the pertinence and quality of double-blind, randomized, placebo-controlled trials were examined. Clinical heterogeneity among studies was also analyzed. The studies were found to be homogeneous, considering p > 0.10 as the significance level for rejecting heterogeneity. Combination of the 16 selected studies resulted in a summary rate ratio of 0.49 (95%CI: 0.41-0.59), i.e., efficacy of 51%, and in a summary rate difference of 11% (95%CI: 8-14), utilizing the fixed effects model. Results according to the random effects model were very similar. Exploratory analysis of subgroups of single versus multiple doses did not indicate more benefit for multiple dose interventions. Evidence from comparative trials is insufficient to consider third-generation cephalosporins more efficacious than first-generation ones
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