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

<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

Narrowing and broadening parameters of H2O lines perturbed by He, Ne, Ar, Kr and nitrogen in the spectral range 1850-2140 cm-1

SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Confinement Narrowing of the R(0) Line in the 13CO Fundamental Band Broadened by Helium from Room Temperature down to 40 K

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Narrowing and broadening parameters for H2O lines in the v2 band perturbed by nitrogen from fourier transform and tunable diode laser spectroscopy

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Line profile study down to 80 K of R(7) in the13CO (1-0) band perturbed by Ar and13CO collisional cooling with he at 6.9 K

SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Line positions and absolute intensities in the laser bands of carbon-12 oxygen-17 isotopic species of carbon dioxide

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Broadening of the R(0) and P(2) lines in the 13CO fundamental by helium atoms from 300 K down to 12 K: Measurements and comparison with close-coupling calculations

We present measurements of He-broadening parameters for the R(0) and P(2) lines in the fundamental band of 13CO at different temperatures between 12 K and room temperature. The broadening parameters are determined, taking into account confinement narrowing, by simultaneous least-squares fitting of spectra recorded using a frequency stabilized diode laser spectrometer. The pressure broadening cross sections are deduced and compared to close-coupling calculations and earlier results obtained for rotational transitions of 12CO. © 2007 Elsevier Inc. All rights reserved.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Broadening of the R(0) and P(2) lines in the 13CO fundamental by helium atoms from 300 K down to 12 K: Measurements and comparison with close-coupling calculations

We present measurements of He-broadening parameters for the R(0) and P(2) lines in the fundamental band of 13CO at different temperatures between 12 K and room temperature. The broadening parameters are determined, taking into account confinement narrowing, by simultaneous least-squares fitting of spectra recorded using a frequency stabilized diode laser spectrometer. The pressure broadening cross sections are deduced and compared to close-coupling calculations and earlier results obtained for rotational transitions of 12CO. © 2007 Elsevier Inc. All rights reserved.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Absolute line intensities of 13C16O2 in the 3090 –3920 cm–1 region

info:eu-repo/semantics/publishe