%0 Journal Article
%T Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol
%A Leticia Krauss-Silva
%A Maria Moreira
%A Mariane B Alves
%A Maria R Rezende
%A Alcione Braga
%A Karla G Camacho
%A Maria Batista
%A Clarisse Savastano
%A Antonio Almada-Horta
%A Fernando Guerra
%J Reproductive Health
%D 2010
%I BioMed Central
%R 10.1186/1742-4755-7-14
%X The purpose of this study is to evaluate the effectiveness of the early administration of selected probiotics to pregnant women with asymptomatic bacterial vaginosis/intermediate degree infection to reduce the occurrence of spontaneous preterm delivery and related neonatal mortality and morbidity.Women attending public prenatal care services in Rio de Janeiro will be screened to select asymptomatic pregnant women, less than 20 weeks' gestation, with no indication of elective preterm delivery. Those with vaginal pH > = 4.5 and a Nugent score between 4 and 10 (intermediate degree infection or bacterial vaginosis) will be randomized to either the placebo or the intervention group, after written informed consent. Intervention consists in the use of probiotics, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14, 2 capsules a day, each capsule containing more than one million bacilli of each strain, for 6-12 weeks, up to the 24th-25th wk of gestation. Ancillary analyses include quantification of selected cervicovaginal cytokines and genotyping of selected polymorphisms. The randomization process is stratified for history of preterm delivery and blocked. Allocation concealment was designed as well as blinding of women, caregivers and outcome evaluators. The study will be supervised by an independent monitoring committee. Outcomes under study are preterm delivery (< 34- < 32 weeks of gestation) and associated neonatal complications: early neonatal sepsis, bronchopulmonary dysplasia, periventricular leukomalacia, necrotizing enterocolitis, and prematurity-related retinopathy; definitions were adapted from those recommended by the 2002 version of the Vermont-Oxford Network. Trial registration at NIH register: NCT00303082.In the United States, where prematurity rates are higher than those in Western Europe, nearly 11% of babies are born premature and preterm delivery is associated to approximately 80% of fetal, neonatal and infants' deaths [1]. Studies in Brazilian u
%U http://www.reproductive-health-journal.com/content/7/1/14