The role of maternal infection in preterm birth: evidence from the Brazilian Multicentre Study on Preterm Birth (EMIP)

OBJECTIVES: Evidence suggests that infection or inflammation is a major contributor to early spontaneous preterm birth (sPTB). Therefore, this study aimed to investigate the development and causes of maternal infection associated with maternal and neonatal outcomes in women with sPTB. METHODS: This was a secondary analysis of a multicenter cross-sectional study with a nested case–control component, the Brazilian Multicentre Study on Preterm Birth (EMIP), conducted from April 2011 to July 2012 in 20 Brazilian referral obstetric hospitals. Women with preterm birth (PTB) and their neonates were enrolled. In this analysis, 2,682 women undergoing spontaneous preterm labor and premature pre-labor rupture of membranes were included. Two groups were identified based on self-reports or prenatal or hospital records: women with at least one infection factor and women without any maternal infection (vulvovaginitis, urinary tract infection, or dental infection). A bivariate analysis was performed to identify potential individual risk factors for PTB. The odds ratios (ORs) with their respective 95% confidence intervals were calculated. RESULTS: The majority of women with sPTB fulfilled at least one criterion for the identification of maternal infection (65.9%), and more than half reported having urinary tract infection during pregnancy. Approximately 9.6% of women with PTB and maternal infection were classified as having periodontal infection only. Apart from the presence of a partner, which was more common among women with infectious diseases (p=0.026; OR, 1.28 [1.03–1.59]), other variables did not show any significant difference between groups. CONCLUSION: Maternal infection was highly prevalent in all cases of sPTBs, although it was not clearly associated with the type of PTB, gestational age, or any adverse neonatal outcomes

Methodological Issues on Planning and Running the Brazilian Multicenter Study on Preterm Birth

Objectives. Assuming that the occurrence of preterm births and their maternal and neonatal associated conditions in Brazil are not completely known, a multicenter study was proposed. The purpose of this paper is to describe the methods used, its processes, achievements, and challenges. Study Design. A multicenter cross-sectional study on preterm births in Brazilian facilities plus a nested case-control study to assess their associated factors. A description of all steps of planning and implementing such a nationwide study, including strategies for dealing with problems arising during the process, is presented. Results. 20 referral hospitals in different regions of Brazil participated in the study. A detailed questionnaire for data collection, an electronic platform for data transcription and monitoring, research materials, and specific monitoring tools were developed; then data management and analyses were performed. Finally, we got information on 4,150 preterm births and 1,146 term births. Conclusions. This study represented the first step of a planned comprehensive assessment of preterm birth in Brazil, with detailed information that will lead to several analyses and further studies, bringing the knowledge to improve screening, diagnosis, and treatment practices in maternal and perinatal health with the final purpose of reducing the burden of this condition in the country

Mother-to-child transmission of human immunodeficiency virus in aten years period

<p>Abstract</p> <p>Objectives</p> <p>to evaluate mother-to-child transmission (MTCT) rates and related factors in HIV-infected pregnant women from a tertiary hospital between 2000 and 2009.</p> <p>Subjects and method</p> <p>cohort of 452 HIV-infected pregnant women and their newborns. Data was collected from recorded files and undiagnosed children were enrolled for investigation. Statistical analysis: qui-square test, Fisher exact test, Student <it>t </it>test, Mann-Whitney test, ANOVA, risk ratio and confidence intervals.</p> <p>Results</p> <p>MTCT occurred in 3.74%. The study population displayed a mean age of 27 years; 86.5% were found to have acquired HIV through sexual contact; 55% were aware of the diagnosis prior to the pregnancy; 62% were not using HAART. Mean CD4 cell-count was 474 cells/ml and 70.3% had undetectable viral loads in the third trimester. HAART included nevirapine in 35% of cases and protease inhibitors in 55%; Zidovudine monotherapy was used in 7.3%. Mean gestational age at delivery was 37.2 weeks and in 92% by caesarian section; 97.2% received intravenous zidovudine. Use of AZT to newborn occurred in 100% of them. Factors identified as associated to MTCT were: low CD4 cell counts, elevated viral loads, maternal AIDS, shorter periods receiving HAART, other conditions (anemia, IUGR (intra uterine growth restriction), oligohydramnium), coinfecctions (CMV and toxoplasmosis) and the occurrence of labor. Use of HAART for longer periods, caesarian and oral zidovudine for the newborns were associated with a decreased risk. Poor adhesion to treatment was present in 13 of the 15 cases of transmission; in 7, coinfecctions were diagnosed (CMV and toxoplasmosis).</p> <p>Conclusion</p> <p>Use of HAART and caesarian delivery are protective factors for mother-to-child transmission of HIV. Maternal coinfecctions and other conditions were risk factors for MTCT.</p

Adverse effects in children exposed to maternal HIV and antiretroviral therapy during pregnancy in Brazil: a cohort study

RESUMO Introdução O uso da terapia antirretroviral (TARV) na gestação se associou a dramática redução da transmissão vertical (TV) do HIV, porém demonstrou poder estar relacionado a efeitos adversos neonatais. O objetivo deste estudo foi avaliar os efeitos neonatais decorrentes da exposição à TARV materna. Métodos estudo observacional analítico de uma coorte de recém-nascidos de gestantes infectadas pelo HIV atendidos no Serviço de Obstetrícia do CAISM/UNICAMP entre 2000 e 2015. Foram avaliados os seguintes efeitos adversos: anemia, plaquetopenia, alteração hepática, prematuridade, baixo peso e malformação congênita. Os dados foram coletados dos prontuários dos pacientes e inseridos em banco específico. A análise descritiva foi realizada por meio de frequências simples (n) e relativas (%) e cálculos de média, desvio-padrão e mediana. As associações entre variáveis foram testadas por meio do Qui-quadrado ou Exato de Fisher (n < 5) e Razão de Risco com respectivo valor de p para as categóricas e por meio do t Student (dados paramétricos) ou Mann-Whitney (não-paramétricos) para as quantitativas. O nível de significância foi de 0,05. A análise multivariada foi realizada através da Regressão Logística de COX. No processamento e análise dos dados, foi utilizado o programa SAS 9.4. Resultados foram analisados dados de 787 recém-nascidos. A taxa de TV do HIV foi de 2,3%, sendo 0,8% nos últimos 5 anos. Os efeitos adversos observados foram alteração hepática (36%), anemia (25,7%), baixo peso (22,5%), prematuridade (21,7%), crianças pequenas para idade gestacional (PIG) (18%), malformações congênitas (10%) e plaquetopenia (3,6%). Em análise multivariada, o CD4 periparto maior que 200 células/mm3 foi protetor para baixo peso e prematuridade, e a cesárea esteve associada ao baixo peso ao nascimento, mas não ao parto prematuro. A anemia esteve associada ao parto prematuro e à exposição a zidovudina materna. A alteração hepática esteve associada à carga viral materna periparto detectável e à exposição a nevirapina. Não houve associação entre diferentes esquemas de TARV e tempo de exposição às drogas maternas com prematuridade, baixo peso e malformação congênita. Conclusão a TARV potente materna com consequente controle da carga viral é o maior fator responsável pela redução da TV do HIV. Ela está associada a frequência elevada de efeitos adversos no recém-nascido, porém a maioria de menor gravidade

Adverse effects of antiretroviral therapy in pregnant women infected with HIV in Brazil from 2000 to 2015: a cohort study

Abstract Background Antiretroviral therapy (ART) use in pregnancy presents unquestionable benefits in preventing mother-to-child transmission (MTCT) of HIV although it is associated with maternal adverse effects. The aim of this study was to evaluate the adverse effects of antiretroviral therapy in pregnant women infected with HIV. Methods Cohort study of pregnant women infected with HIV followed at the CAISM/UNICAMP Obstetric Clinic from 2000 to 2015. The following maternal adverse effects were observed: anemia, thrombocytopenia, allergy, liver function test abnormalities, dyslipidemia and diabetes. Data collected from patients’ files was added to a specific database. Descriptive analysis was shown in terms of absolute (n) and relative (%) frequencies and mean, median and standard deviation calculations. Chi-square or Fisher exact test (n < 5) and relative risk (RR) with its respective p values were used for categorical variables and Student t-test (parametric data) or Mann-Whitney (non-parametric data) for the quantitative ones. A 95% confidence interval (CI) and a significant level of 0.05 were used. A multivariate Cox Logistic Regression was also done. Data analysis was conducted using SAS version 9.4. Results Data from 793 pregnancies were included. MTCT rate was 2.3%, with 0.8% in the last 5 years. Maternal adverse effects were: dyslipidemia (82%), anemia (56%), liver function test abnormalities (54.5%), including hyperbilirubinemia (11.6%), fasting glycemia alteration (19.2%), thrombocytopenia (14.1%), and allergic reaction (2.7%). The majority of adverse effects deemed related to ART in this study were mild according to DAIDS scale. In the multivariate analysis, co-infections and starting ART during pregnancy were risk factors for maternal anemia, while CD4 count higher than 200 cells/mm3 was protective. Nevirapine, nelfinavir and atazanavir regimens increased the risk for liver function tests abnormalities. Lopinavir use during pregnancy increased the risk for fasting glycemia alteration. Conclusion The evolution of the national guidelines of antiretroviral therapy for pregnant women improved adherence to the treatment and resulted in a significant reduction of MTCT. Despite the high frequency of maternal adverse effects, they are mostly of low severity. Newer ART medications with improved efficacy and significantly more favorable tolerability profiles should reduce the incidence of ART-related adverse effects

Intracluster Correlation Coefficients For The Brazilian Multicenter Study On Preterm Birth (emip): Methodological And Practical Implications.

Cluster-based studies in health research are increasing. An important characteristic of such studies is the presence of intracluster correlation, typically quantified by the intracluster correlation coefficient (ICC), that indicate the proportion of data variability that is explained by the way of clustering. The purpose of this manuscript was to evaluate ICC of variables studied in the Brazilian Multicenter Study on Preterm Birth. This was a multicenter cross-sectional study on preterm births involving 20 referral hospitals in different regions of Brazil plus a nested case-control study to assess associated factors with spontaneous preterm births. Estimated prevalence rates or means, ICC with 95% confidence intervals, design effects and mean cluster sizes were presented for more than 250 maternal and newborn variables. Overall, 5296 cases were included in the study (4,150 preterm births and 1,146 term births). ICC ranged from 0.3 was found in some clinical management aspects well defined in literature such as use of corticosteroids, indicating there was homogeneity in clusters for these variables. Clusters selected for Brazilian Multicenter Study on Preterm Birth had mainly heterogeneous findings and these results can help researchers estimate the required sample size for future studies on maternal and perinatal health.145

Intracluster correlation coefficients for the brazilian multicenter study on preterm birth (EMIP): methodological and practical implications

Made available in DSpace on 2014-11-06T17:31:58Z (GMT). No. of bitstreams: 2 Intracluster correlation coefficients for the.pdf: 215274 bytes, checksum: 438b9ae2f93a632f1523fc800284e630 (MD5) license.txt: 1914 bytes, checksum: 7d48279ffeed55da8dfe2f8e81f3b81f (MD5) Previous issue date: 2014Universidade de Campinas. Faculdade de Ciências Médicas. Departamento de Obstetrícia e Ginecologia. Campinas, SP, Brasil.Universidade de Campinas. Faculdade de Ciências Médicas. Departamento de Obstetrícia e Ginecologia. Campinas, SP, Brasil.Universidade de Campinas. Faculdade de Ciências Médicas. Departamento de Obstetrícia e Ginecologia. Campinas, SP, Brasil.Universidade de Campinas. Faculdade de Ciências Médicas. Departamento de Obstetrícia e Ginecologia. Campinas, SP, Brasil.Universidade de Campinas. Faculdade de Ciências Médicas. Departamento de Obstetrícia e Ginecologia. Campinas, SP, Brasil.Universidade de Campinas. Faculdade de Ciências Médicas. Departamento de Obstetrícia e Ginecologia. Campinas, SP, Brasil.Universidade de Campinas. Faculdade de Ciências Médicas. Departamento de Obstetrícia e Ginecologia. Campinas, SP, Brasil.Centro de Estudos Reprodutivos em Saúde de Campinas. (Cemicamp). Campinas, SP, Brasil.Universidade de Campinas. Faculdade de Ciências Médicas. Departamento de Obstetrícia e Ginecologia. Campinas, SP, Brasil. / Centro de Estudos Reprodutivos em Saúde de Campinas. (Cemicamp). Campinas, SP, Brasil.Background: Cluster-based studies in health research are increasing. An important characteristic of such studies is the presence of intracluster correlation, typically quantified by the intracluster correlation coefficient (ICC), that indicate the proportion of data variability that is explained by the way of clustering. The purpose of this manuscript was to evaluate ICC of variables studied in the Brazilian Multicenter Study on Preterm Birth. Methods: This was a multicenter cross-sectional study on preterm births involving 20 referral hospitals in different regions of Brazil plus a nested case–control study to assess associated factors with spontaneous preterm births. Estimated prevalence rates or means, ICC with 95% confidence intervals, design effects and mean cluster sizes were presented for more than 250 maternal and newborn variables. Results: Overall, 5296 cases were included in the study (4,150 preterm births and 1,146 term births). ICC ranged from <0.001 to 0.965, with a median of 0.028. For descriptive characteristics (socio-demographic, obstetric history and perinatal outcomes) the median ICC was 0.014, for newborn outcomes the median ICC was 0.041 and for process variables (clinical management and delivery), it was 0.102. ICC was <0.1 in 78.4% of the variables and <0.3 for approximately 95% of them. Most of ICC >0.3 was found in some clinical management aspects well defined in literature such as use of corticosteroids, indicating there was homogeneity in clusters for these variables. Conclusions: Clusters selected for Brazilian Multicenter Study on Preterm Birth had mainly heterogeneous findings and these results can help researchers estimate the required sample size for future studies on maternal and perinatal health

Brazilian multicentre study on preterm birth (EMIP): prevalence and factors associated with spontaneous preterm birth

Background:Preterm birth rate is increasing and is currently a worldwide concern. The purpose of this study was to estimate the prevalence of preterm birth in a sample of health facilities in Brazil and to identify the main risk factors associated with spontaneous preterm births. Methods and Findings:This was a multicentre cross sectional study on preterm births in 20 referral obstetric hospitals with a case-control component to identify factors associated with spontaneous preterm birth. Surveillance was implemented at all centres to identify preterm births. For eligible consenting women, data were collected through a post-delivery questionnaire completed with information from all mother-newborn medical records until death or discharge or at a maximum of 60 days post-delivery, whichever came first. The risk of spontaneous preterm birth was estimated with OR and 95%CI for several predictors. A non-conditional logistic regression analysis was then performed to identify independently associated factors. The overall prevalence of preterm birth was 12.3%. Among them, 64.6% were spontaneous and 35.4% therapeutic. In the case-control component, 2,682 spontaneous preterm births were compared to a sample of 1,146 term births. Multivariate analyses identified the following as risk factors for spontaneous preterm birth among women with at least one previous birth: a previous preterm birth (OR adj= 3.19, 2.30–4.43), multiple pregnancy (ORadj = 29.06, 8.43–100.2), cervical insufficiency (ORadj= 2.93, 1.07–8.05), foetal malformation (ORadj= 2.63, 1.43–4.85), polyhydramnios (ORadj = 2.30, 1.17–4.54), vaginal bleeding (ORadj= 2.16, 1.50–3.11), and previous abortion (ORadj= 1.39, 1.08–1.78). High BMI (ORadj = 0.94, 0.91–0.97) and weight gain during gestation (ORadj = 0.92, 0.89–0.95) were found to be protective factors. Conclusions:The preterm birth rate in these health facilities in Brazil is high and spontaneous preterm births account for two thirds of them. A better understanding of the factors associated with spontaneous preterm birth is of utmost importance for planning effective measures to reduce the burden of its increasing rates

The Burden of Provider-Initiated Preterm Birth and Associated Factors: Evidence from the Brazilian Multicenter Study on Preterm Birth (EMIP)

<div><p>Background</p><p>About 15 million children are born under 37 weeks of gestation worldwide. Prematurity is the leading cause of neonatal deaths and short/long term morbidities, entailing consequences not only for the individual, but also their family, health agencies, facilities and all community. The provider-initiated preterm birth is currently one of the most important obstetric conditions related to preterm births, particularly in middle and high income countries, thus decreasing the need for therapeutic preterm birth is essential to reduce global prematurity. Therefore detailed knowledge on the factors associated with provider-initiated preterm birth is essential for the efforts to reduce preterm birth rates and its consequences. In this current analysis we aimed to assess the proportion of provider-initiated (pi-PTB) among preterm births in Brazil and identify associated factors.</p><p>Methods and Findings</p><p>This is an analysis of a multicenter cross-sectional study with a nested case-control component called Brazilian Multicenter Study on Preterm Birth (EMIP). EMIP was conducted in 20 referral obstetric hospitals located in the three most populated of the five Brazilian regions. We analysed data of women with pi-PTB, defined as childbirth occurring at less than 37 weeks, medically indicated for maternal/fetal compromise or both; and women with term birth, childbirth at or after 37 weeks. Maternal, sociodemographic, obstetric, prenatal care, delivery, and postnatal characteristics were assessed as possible factors associated with pi-PTB, compared to term births. The overall prevalence of preterm births was 12.3%. Of these, approximately one-third of cases were initiated by the provider. Hypertensive disorders, placental abruption, and diabetes were the main maternal conditions leading to pi-PTB. Caesarean section was the most common mode of delivery. Chronic hypertension (OR 7.47; 95%CI 4.02–13.88), preeclampsia/eclampsia/HELLP syndrome (OR 15.35; 6.57–35.88), multiple pregnancy (OR 12.49; 4.86–32.05), and chronic diabetes (OR 5.24; 2.68–10.25) were the most significant factors independently associated with pi-PTB.</p><p>Conclusions</p><p>pi-PTB is responsible for about one-third of all preterm births, requiring special attention. The decision-making process relative to the choice of provider-initiated birth is complex, and many factors should be elucidated to improve strategies for its prevention, including evidence-based guidelines on proper management of the corresponding clinical conditions.</p></div