A randomised controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with bacterial vaginosis: preliminary results

BACKGROUND: Bacterial vaginosis increases the risk of spontaneous preterm delivery at less than 34 weeks of gestation. OBJECTIVE: The purpose of this study was to evaluate the efficacy of the early administration of selected lactobacilli strains (probiotics) to pregnant women with asymptomatic bacterial vaginosis/intermediate-degree infections to prevent spontaneous premature delivery and associated neonatal morbidity. METHODS/DESIGN: Asymptomatic pregnant women at less than 20 weeks of gestation, with no indication of elective preterm delivery, with a vaginal pH ??? 4.5 and Nugent score > 3 were randomly assigned to the placebo or intervention group (oral administration of selected lactobacilli up to the 24th to 26th week of gestation). The randomisation was stratified for the history of premature delivery (HPD) and blocked. The allocation was concealed, and the participating health professionals and patients were blinded. The primary outcome was preterm delivery (<34 to <32 weeks), and the secondary outcomes were associated neonatal complications. RESULTS: In total, 4,204 pregnant women were screened; 320 and 324 individuals were respectively randomly assigned to the placebo and intervention groups, and 62% finished the trial. None of the randomised patients were lost to follow-up. For the non-HPD stratum, the intent-to-treat relative risks of spontaneous premature birth at < 34 and < 37 weeks' gestation were 0.33 (0.03, 3.16) and 0.49 (0.17, 1.44), respectively, and they were non-significant (ns) with p = 0.31 and 0.14. The corresponding actual treatment figures were zero and 0.32 (0.09, 1.19), which were ns with p = 0.12 and 0.06. The intent-to-treat relative risk of spontaneous premature birth at < 37 weeks of gestation for the trial as a whole, including HPD and non-HPD participants, was 0.69 (0.26, 1.78), p = 0.30 (ns). The neonatal complications under evaluation occurred in only one infant (< 34 weeks; placebo group) who presented with respiratory distress syndrome and suspected early neonatal sepsis. The recorded adverse events were minor and relatively non-specific. CONCLUSIONS: The efficacy of the tested probiotics to prevent preterm delivery among women without a history of preterm delivery was not determined because the study sample was insufficient to estimate statistically significant intent-to-treat effects; additional studies are needed to evaluate this intervention among these women

Abnormal Vaginal Flora in Low-Risk Pregnant Women Cared for by a Public Health Service: prevalence and Association with Symptoms and Findings from Gynecological Exams

This study identifies the prevalence of vaginal flora alterations in low-risk pregnant women and their association with reported symptoms and gynecological exams. This quantitative, descriptive, cross-sectional study was conducted in public primary care service units in Botucatu, SP, Brazil from 2006 to 2008 with 289 pregnant women from a stratified sample obtained by sampling by care unit. Tests of vaginal content were performed using Gram’s method and testing for Trichomonas vaginalis using Diamond’s medium. The prevalence of altered vaginal flora was 49.5%, of which bacterial vaginosis (20.7%), vaginal candidiasis (11.8%) and intermediate flora (11.1%) were the most frequent, not considering associations. Results revealed a high prevalence of vaginal flora alterations with little relation to symptoms, but in agreement with findings from the gynecological exams. Considering undesirable maternal and perinatal outcomes and feasible laboratory practices, the establishment of a routine for diagnosing vaginal flora alterations in low-risk pregnant women is suggested.Se tuvo por objetivo identificar la prevalencia de las alteraciones de flora vaginal en gestantes de bajo riesgo, su asociación a la sintomatología referida y examen ginecológico. Estudio cuantitativo, descriptivo y transversal, desarrollado en el servicio público de atención básica de Botucatu/SP, en el período de 2006 a 2008, con 289 gestantes, el muestreo fue realizado de forma estratificada por unidad. Se realizó examen del contenido vaginal utilizándose coloración por el método de Gram e investigación de Trichomonas vaginalis en medio líquido de Diamond. Desconsiderándose las asociaciones, la prevalencia de flora vaginal alterada fue de 49.5%, siendo las alteraciones más frecuentes: vaginitis bacteriana (20.7%), candidiasis vaginal (11.8%) y flora intermediaria (11.1%). Los datos apuntan elevada prevalencia de las alteraciones de flora vaginal, con poca asociación a la sintomatología, pero con asociación a hallazgos del examen ginecológico. Considerándose las repercusiones maternas y perinatales indeseables y la práctica de laboratorio ejecutable, se sugiere el establecimiento de rutina para diagnóstico de las alteraciones de flora vaginal en gestantes de bajo riesgo.Objetivou-se identificar a prevalência das alterações de flora vaginal em gestantes de baixo risco, sua associação à sintomatologia referida e exame ginecológico. É estudo quantitativo, descritivo e transversal, desenvolvido no serviço público de atenção básica de Botucatu, SP, no período de 2006 a 2008, com 289 gestantes, amostradas de forma estratificada por unidade. Realizou-se exame do conteúdo vaginal, utilizando-se coloração pelo método de Gram e pesquisa de Trichomonas vaginalis em meio líquido de Diamond. Desconsiderando-se as associações, a prevalência de flora vaginal alterada foi de 49,5%, sendo as mais frequentes: vaginose bacteriana (20,7%), candidíase vaginal (11,8%) e flora intermediária (11,1%). Os dados apontam elevada prevalência das alterações de flora vaginal, com pouca associação à sintomatologia, mas associação com achados do exame ginecológico. Considerando-se as repercussões maternas e perinatais indesejáveis e a prática laboratorial exequível, sugere-se o estabelecimento de rotina para diagnóstico das alterações de flora vaginal em gestantes de baixo risco