Abstract
BackgroundBacterial vaginosis increases the risk of spontaneous preterm delivery at less than 34 weeks of gestation.ObjectiveThe 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/DesignAsymptomatic 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.ResultsIn 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.ConclusionsThe 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.Trial registrationTrial registration at NIH register: NCT00303082. Sources of funding: the Brazilian Health Ministry and the State of Rio de Janeiro Research Foundation.
Highlights
Bacterial vaginosis increases the risk of spontaneous preterm delivery at less than 34 weeks of gestation
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
A history of preterm delivery (HPD) is the most important factor in spontaneous preterm delivery; history of premature delivery (HPD) increases the risk of a subsequent preterm delivery by threefold and is likely associated with underlying risk factors [4,7,8]
Summary
Bacterial vaginosis increases the risk of spontaneous preterm delivery at less than 34 weeks of gestation. 25% of preterm deliveries occur as the result of medical indications, and the remaining cases occur spontaneously [4]. Spontaneous preterm deliveries that occur prior to 35 weeks of gestation, and before the 32nd week in particular, have been strongly associated with intrauterine infections, including bacterial vaginosis (BV) [5,6]. Important risk factors for spontaneous preterm delivery, such as age < 18 years, race, education, and bacterial vaginosis, are associated with a low socioeconomic status. BV doubles the risk of preterm delivery prior to 35 weeks of gestation [7]. BV is present in 1520% of normal pregnant women in developed countries [7], and this proportion is almost twice as high in highrisk populations [9]
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