Effect of nusinersen on motor, respiratory and bulbar function in early-onset spinal muscular atrophy.

5q-associated spinal muscular atrophy is a rare neuromuscular disorder with the leading symptom of a proximal muscle weakness. Three different drugs have been approved by the European Medicines Agency and Food and Drug Administration for the treatment of spinal muscular atrophy patients, however, long-term experience is still scarce. In contrast to clinical trial data with restricted patient populations and short observation periods, we report here real-world evidence on a broad spectrum of patients with early-onset spinal muscular atrophy treated with nusinersen focusing on effects regarding motor milestones, and respiratory and bulbar insufficiency during the first years of treatment. Within the SMArtCARE registry, all patients under treatment with nusinersen who never had the ability to sit independently before the start of treatment were identified for data analysis. The primary outcome of this analysis was the change in motor function evaluated with the Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders and motor milestones considering World Health Organization criteria. Further, we evaluated data on the need for ventilator support and tube feeding, and mortality. In total, 143 patients with early-onset spinal muscular atrophy were included in the data analysis with a follow-up period of up to 38 months. We observed major improvements in motor function evaluated with the Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders. Improvements were greater in children >2 years of age at start of treatment than in older children. 24.5% of children gained the ability to sit independently. Major improvements were observed during the first 14 months of treatment. The need for intermittent ventilator support and tube feeding increased despite treatment with nusinersen. Our findings confirm the increasing real-world evidence that treatment with nusinersen has a dramatic influence on disease progression and survival in patients with early-onset spinal muscular atrophy. Major improvements in motor function are seen in children younger than 2 years at the start of treatment. Bulbar and respiratory function needs to be closely monitored, as these functions do not improve equivalent to motor function.

Improvements in Walking Distance during Nusinersen Treatment - A Prospective 3-year SMArtCARE Registry Study.

BACKGROUND AND OBJECTIVES: Disease progression in patients with spinal muscular atrophy (SMA) has changed dramatically within the past years due to the approval of three different disease-modifying treatments. Nusinersen was the first drug to be approved for the treatment of SMA patients. Clinical trials provided data from infants with SMA type 1 and children with SMA type 2, but there is still insufficient evidence and only scarcely reported long-term experience for nusinersen treatment in ambulant patients. Here, we report data from the SMArtCARE registry of ambulant patients under nusinersen treatment with a follow-up period of up to 38 months. METHODS: SMArtCARE is a disease-specific registry in Germany, Austria and Switzerland. Data are collected as real-world data during routine patient visits. Our analysis included all patients under treatment with nusinersen able to walk independently before start of treatment with focus on changes in motor function. RESULTS: Data from 231 ambulant patients were included in the analysis. During the observation period, 31 pediatric walkers (27.2%) and 31 adult walkers (26.5%) experienced a clinically meaningful improvement of≥30 m in the 6-Minute-Walk-Test. In contrast, only five adult walkers (7.7%) showed a decline in walking distance≥30 m, and two pediatric walkers (1.8%) lost the ability to walk unassisted under treatment with nusinersen. HFMSE and RULM scores improved in pediatric and remained stable in adult patients. CONCLUSION: Our data demonstrate a positive effect of nusinersen treatment in most ambulant pediatric and adult SMA patients. We not only observed a stabilization of disease progression or lack of deterioration, but clinically meaningful improvements in walking distance.

Improved upper limb function in non-ambulant children with SMA type 2 and 3 during nusinersen treatment: a prospective 3-years SMArtCARE registry study.

BACKGROUND: The development and approval of disease modifying treatments have dramatically changed disease progression in patients with spinal muscular atrophy (SMA). Nusinersen was approved in Europe in 2017 for the treatment of SMA patients irrespective of age and disease severity. Most data on therapeutic efficacy are available for the infantile-onset SMA. For patients with SMA type 2 and type 3, there is still a lack of sufficient evidence and long-term experience for nusinersen treatment. Here, we report data from the SMArtCARE registry of non-ambulant children with SMA type 2 and typen 3 under nusinersen treatment with a follow-up period of up to 38 months. METHODS: SMArtCARE is a disease-specific registry with data on patients with SMA irrespective of age, treatment regime or disease severity. Data are collected during routine patient visits as real-world outcome data. This analysis included all non-ambulant patients with SMA type 2 or 3 below 18 years of age before initiation of treatment. Primary outcomes were changes in motor function evaluated with the Hammersmith Functional Motor Scale Expanded (HFMSE) and the Revised Upper Limb Module (RULM). RESULTS: Data from 256 non-ambulant, pediatric patients with SMA were included in the data analysis. Improvements in motor function were more prominent in upper limb: 32.4% of patients experienced clinically meaningful improvements in RULM and 24.6% in HFMSE. 8.6% of patients gained a new motor milestone, whereas no motor milestones were lost. Only 4.3% of patients showed a clinically meaningful worsening in HFMSE and 1.2% in RULM score. CONCLUSION: Our results demonstrate clinically meaningful improvements or stabilization of disease progression in non-ambulant, pediatric patients with SMA under nusinersen treatment. Changes were most evident in upper limb function and were observed continuously over the follow-up period. Our data confirm clinical trial data, while providing longer follow-up, an increased number of treated patients, and a wider range of age and disease severity.

Functional outcome measures in young, steroid-naïve boys with Duchenne muscular dystrophy.

The purpose of this study was to quantitate motor performance in 196 genetically confirmed steroid-naïve boys with Duchenne muscular dystrophy (DMD), to evaluate the test-retest reliability of measures of motor performance in young DMD boys, and to assess correlations among the different functional outcomes including timed tests. Boys aged 4-7 years were recruited in the FOR-DMD study, a comparative effectiveness study of different steroid regimens in DMD. Eligible boys had to be able to rise from the floor independently and to perform pulmonary function testing consistently. The boys were evaluated with standardized assessments at the screening and baseline visits at 32 sites in 5 countries (US, UK, Canada, Italy, Germany). Assessments included timed rise from floor, timed 10 m walk/run, six-minute walk distance, North Star Ambulatory Assessment (NSAA) and forced vital capacity (FVC). Mean age at baseline was 5.9 years (range 4.1-8.1 years). Test-retest reliability was high for functional assessments, regardless of time lag between assessments (up to 90 days) and for the majority of age groups. Correlations were strong among the functional measures and timed tests, less so with FVC. Physiotherapy measures are reliable in a young, steroid-naïve population and rise from floor velocity appears to be a sensitive measure of strength in this population.

Preventing vertical HIV virus transmission: hospital care assessment.

OBJECTIVES: assess the implementation of actions to prevent vertical transmission of HIV. METHODS: a retrospective cohort study conducted in two maternity hospitals in the city of Montes Claros, State of Minas Gerais. All women admitted for childbirth diagnosed with HIV and their respective newborns were included from 2014 to 2017. Data were collected from medical records and analyzed descriptively. RESULTS: population consisted of 46 pairs of mothers and newborns. Management was considered inadequate in 30 cases of parturient/postpartum women (65.2%) and 14 cases of newborns (30.4%). The main reasons for inadequate maternal management were lack of pharmacological inhibition of lactation (53.3%) and counseling/consent for HIV testing (43.3%). For newborns, late onsetoffirst dose ofZidovudine (50.0%) and no prescriptionofNevirapine (28.6%). CONCLUSIONS: important prevention opportunities were missed, pointing to the need for improved care.

Factors associated with low Apgar in newborns in birth center.

OBJECTIVE: to analyze factors associated with Apgar of 5 minutes less than 7 of newborns of women selected for care at the Center for Normal Birth (ANC). METHOD: a descriptive cross-sectional study with data from 9,135 newborns collected between July 2001 and December 2012. The analysis used absolute and relative frequency frequencies and bivariate analysis using Pearson's chi-square test or the exact Fisher. RESULTS: fifty-three newborns (0.6%) had Apgar less than 7 in the 5th minute. The multivariate analysis found a positive association between low Apgar and gestational age less than 37 weeks, gestational pathologies and intercurrences in labor. The presence of the companion was a protective factor. CONCLUSION: the Normal Birth Center is a viable option for newborns of low risk women as long as the protocol for screening low-risk women is followed.

SMArtCARE - A platform to collect real-life outcome data of patients with spinal muscular atrophy.

BACKGROUND: Survival and quality of life for patients affected by spinal muscular atrophy (SMA) are thought to have improved over the last decade due to changes in care. In addition, targeted treatments for SMA have been developed based on a better understanding of the molecular pathology. In 2016 and 2017, nusinersen was the first drug to be approved for treatment of all types of SMA in the United States and in Europe based on well-controlled clinical trials in a small subgroup of pediatric SMA patients. Systems are required to monitor treated and untreated SMA patients in a real-life environment to optimize treatment and care, and to provide outcome data to regulators, payers, and the SMA community. METHODS: Within SMArtCARE, we conduct a prospective, multicenter non-randomized registration and outcome study. SMArtCARE collects longitudinal data on all available SMA patients independent of their actual treatment regime as disease-specific SMA registry. For this purpose, we provide an online platform for SMA patients seen by health-care providers in Germany, Austria and Switzerland. All data are collected during routine patient visits. Items for data collection are aligned with the international consensus for SMA registries. Data analysis is carried out independent of commercial partners. CONCLUSION: A prospective monitoring of all SMA patients will lead to a better understanding of the natural history of SMA and the influence of drug treatment. This is crucial to improve the care of SMA patients. Further, we will establish a network for neuromuscular centers to share experience with SMA patients and to promote research projects on SMA. TRIAL REGISTRATION: German Clinical Trials Register ("Deutsches Register klinischer Studien") DRKS00012699. Registered 09 August 2018. https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00012699 .

Evaluation of Children with SMA Type 1 Under Treatment with Nusinersen within the Expanded Access Program in Germany.

BACKGROUND: Spinal muscular atrophy (SMA) is a neuromuscular disorder characterized by muscle weakness and muscle atrophy. Nusinersen acts as a splicing modifier and has recently been approved for intrathecal treatment of SMA. OBJECTIVE: Prior to approval, nusinersen was provided to patients with SMA type 1 in Germany within an Expanded Access Program (EAP). In contrast to previous clinical trials, children of different age groups and different stages of the disease were treated with nusinersen. METHODS: We conducted a prospective, longitudinal data collection of patients treated with nusinersen within the EAP in seven neuromuscular centers in Germany. Standardized assessments including CHOP-INTEND and HINE-2 motor milestones were performed at baseline and 60 and 180 days after start of treatment. RESULTS: Data from 61 SMA type 1 patients (mean age 21.08 months, range 1-93) were available for analysis. After six months of treatment, 47 children (77.0%) improved by ≥4 points in CHOP INTEND score. Mean change in CHOP INTEND score was 9.0±8.0 points. Nineteen patients (31.1%) improved by ≥2 points in HINE-2 motor milestones. Regression analysis revealed age at onset of treatment as major determinant of change in CHOP INTEND from baseline. CONCLUSION: When analyzing a broad spectrum of SMA type 1 patients, many children showed an improvement of motor function after six months of treatment with nusinersen, which is generally not expected within the natural course of the disease. Long-term observation and follow-up of patients with later onset types of SMA are crucial to understand the clinical impact of treatment with nusinersen.

Cumprimento das demandas articuladas no plano de parto entre usuárias do sistema público de saúde / Compliance with articulated demands in the childbirth plan among users of the public health system / Cumplimiento de las demandas articuladas en el plan de parto entre usuarios del sistema de salud pública

Objetivo: Avaliar o cumprimento do PP entre usuárias de Unidades Básicas de Saúde (UBS), do Sistema Único de Saúde (SUS), no município de Montes Claros, Minas Gerais, entre os meses de março a setembro de 2014. Métodos: Estudo transversal, descritivo, realizado entre os meses de março a setembro de 2014, com 48 gestantes participantes de rodas de conversas em Unidades Básicas de Saúde. Os dados foram analisados através de frequências absolutas e relativas. Resultados: 41 (85,4%) mulheres não possuíam conhecimento prévio acerca do plano de parto, 28 (58,3%) relataram que ele ajudou no trabalho de parto, 11 (22,9%) o apresentaram na admissão e 17 (35,4%) informaram suas escolhas à equipe verbalmente. As demandas mais cumpridas foram a presença do acompanhante, livre movimentação e uso de métodos não farmacológicos para alívio da dor. Conclusão: Os resultados do presente estudo são evidências importantes para a promoção de políticas públicas voltadas à assistência obstétrica. (AU).

Objective: Evaluate the fulfillment of the PP among users of Basic Health Units (UBS), of the Unified Health System (SUS), in the municipality of Montes Claros, Minas Gerais, between March and September 2014. Methods: Cross-sectional, descriptive study, carried out between March and September 2014, with 48 pregnant women participating in conversation circles at Basic Health Units. Data were analyzed using absolute and relative frequencies. Results: 41 (85.4%) women had no prior knowledge about the birth plan, 28 (58.3%) reported that it helped in labor, 11 (22.9%) presented it on admission and 17 ( 35.4%) informed their choices verbally to the team. The most fulfilled demands were the presence of the companion, free movement and use of non-pharmacological methods for pain relief. Conclusion: The results of the present study are important evidence for the promotion of public policies aimed at obstetric care. (AU).

Objetivo: Evaluar el cumplimiento del PP entre usuarios de Unidades Básicas de Salud (UBS), del Sistema Único de Salud (SUS), en el municipio de Montes Claros, Minas Gerais, entre marzo y septiembre de 2014. Métodos: Estudio transversal, descriptivo, realizado entre marzo y septiembre de 2014, con 48 gestantes participantes de ruedas de conversación en Unidades Básicas de Salud. Los datos se analizaron utilizando frecuencias absolutas y relativas. Resultados: 41 (85,4%) mujeres no tenían conocimiento previo sobre el plan de parto, 28 (58,3%) informaron que ayudó en el parto, 11 (22,9%) lo presentaron al ingreso y 17 ( 35,4%) informaron verbalmente sus elecciones al equipo. Las demandas más cumplidas fueron la presencia del acompañante, la libre circulación y el uso de métodos no farmacológicos para el alivio del dolor. Conclusión: Los resultados del presente estudio son evidencia importante para la promoción de políticas públicas dirigidas a la atención obstétrica. (AU).

Preventing vertical HIV virus transmission: hospital care assessment / Prevención de la transmisión vertical del virus del VIH: evaluación de la asistencia hospitalaria / Prevenção da transmissão vertical do vírus HIV: avaliação da assistência hospitalar

ABSTRACT Objectives: assess the implementation of actions to prevent vertical transmission of HIV. Methods: a retrospective cohort study conducted in two maternity hospitals in the city of Montes Claros, State of Minas Gerais. All women admitted for childbirth diagnosed with HIV and their respective newborns were included from 2014 to 2017. Data were collected from medical records and analyzed descriptively. Results: population consisted of 46 pairs of mothers and newborns. Management was considered inadequate in 30 cases of parturient/postpartum women (65.2%) and 14 cases of newborns (30.4%). The main reasons for inadequate maternal management were lack of pharmacological inhibition of lactation (53.3%) and counseling/consent for HIV testing (43.3%). For newborns, late onsetoffirst dose ofZidovudine (50.0%) and no prescriptionofNevirapine (28.6%). Conclusions: important prevention opportunities were missed, pointing to the need for improved care.

RESUMEN Objetivos: evaluar la implementación de acciones para prevenir la transmisión vertical del VIH. Métodos: estudio de cohorte retrospectivo realizado en dos hospitales de maternidad em la ciudad de Montes Claros, estado de Minas Gerais. Todas las mujeres ingresadas para el parto diagnosticadas con VIH y sus respectivos reciénnacidos se incluyeron entre 2014 y 2017. Los datos se recopilaron de los registros médicos y se analizaron descriptivamente. Resultados: la población consistió en 46 pares de madres y reciénnacidos. El manejo se consideró inadecuado en 30 casos de mujeres parturientas/posparto (65,2%) y 14 casos de reciénnacidos(30,4%). Las razones principales para el manejo materno inadecuado fueron: falta de inhibición farmacológica de lalactancia (53.3%) y asesoramiento/consentimiento para la prueba del VIH (43,3%). Para los reciénnacidos, inicio tardío de la primera dosis de zidovudina (50.0%) y sin prescripción de nevirapina (28,6%). Conclusiones: se perdieron importantes oportunidades de prevención, lo que indica la necesidad de una mejor atención.

RESUMO Objetivos: avaliar a implementação das ações de prevenção da transmissão vertical do HIV. Métodos: estudo de coorte retrospectivo, realizado em duas maternidades de Montes Claros, Minas Gerais. Foram incluídas todas as mulheres admitidas para o parto com diagnóstico de HIV e seus respectivos recém-nascidos, nos anos de 2014 a 2017. Os dados foram coletados de prontuários e analisados de forma descritiva. Resultados: a população foi composta por 46 pares de mães e recém-nascidos. O manejo foi considerado inadequado em 30 casos de parturientes/puérperas (65,2 %) e em 14 casos de recém-nascidos (30,4%). Os principais motivos para a inadequação do manejo materno foram: ausência da inibição farmacológica da lactação (53,3%) e do aconselhamento/consentimento na realização do exame anti-HIV (43,3%). Para os recém-nascidos, início tardio da primeira dose daZidovudina (50,0%) e não prescrição da Nevirapina (28,6%). Conclusões: oportunidades importantes de prevenção foram perdidas, apontando para a necessidade de melhoria da assistência.

Comparison of childbirth care models in public hospitals, Brazil.

OBJECTIVE: To compare collaborative and traditional childbirth care models. METHODS: Cross-sectional study with 655 primiparous women in four public health system hospitals in Belo Horizonte, MG, Southeastern Brazil, in 2011 (333 women for the collaborative model and 322 for the traditional model, including those with induced or premature labor). Data were collected using interviews and medical records. The Chi-square test was used to compare the outcomes and multivariate logistic regression to determine the association between the model and the interventions used. RESULTS: Paid work and schooling showed significant differences in distribution between the models. Oxytocin (50.2% collaborative model and 65.5% traditional model; p < 0.001), amniotomy (54.3% collaborative model and 65.9% traditional model; p = 0.012) and episiotomy (collaborative model 16.1% and traditional model 85.2%; p < 0.001) were less used in the collaborative model with increased application of non-pharmacological pain relief (85.0% collaborative model and 78.9% traditional model; p = 0.042). The association between the collaborative model and the reduction in the use of oxytocin, artificial rupture of membranes and episiotomy remained after adjustment for confounding. The care model was not associated with complications in newborns or mothers neither with the use of spinal or epidural analgesia. CONCLUSIONS: The results suggest that collaborative model may reduce interventions performed in labor care with similar perinatal outcomes.

Factors associated with low Apgar in newborns in birth center / Factores asociados al bajo Apgar en recién nacidos en centro de parto / Fatores associados ao baixo Apgar em recém-nascidos em centro de parto

ABSTRACT Objective: to analyze factors associated with Apgar of 5 minutes less than 7 of newborns of women selected for care at the Center for Normal Birth (ANC). Method: a descriptive cross-sectional study with data from 9,135 newborns collected between July 2001 and December 2012. The analysis used absolute and relative frequency frequencies and bivariate analysis using Pearson's chi-square test or the exact Fisher. Results: fifty-three newborns (0.6%) had Apgar less than 7 in the 5th minute. The multivariate analysis found a positive association between low Apgar and gestational age less than 37 weeks, gestational pathologies and intercurrences in labor. The presence of the companion was a protective factor. Conclusion: the Normal Birth Center is a viable option for newborns of low risk women as long as the protocol for screening low-risk women is followed.

RESUMEN Objetivo: analizar los factores asociados al Apgar de quinto minuto menor que siete de los recién nacidos de mujeres, seleccionadas para la asistencia en el Centro de Parto Normal (CPN). Método: estudio descriptivo transversal con datos de 9.135 recién nacidos, recogidos entre julio de 2001 y diciembre de 2012. En el análisis se utilizaron el escrutado de frecuencias absolutas y relativas de las variables y el análisis bivariado mediante el cálculo de la prueba de Chi-cuadrado de Pearson o prueba exacta de Pearson Fisher. Resultados: cincuenta y tres recién nacidos (0,6%) tuvieron Apgar menor que siete en el quinto minuto. El análisis multivariado encontró asociación positiva entre bajo Apgar y edad gestacional menor que 37 semanas, patologías en la gestación e interocurrencias en el trabajo de parto. La presencia del acompañante fue un factor protector. Conclusión: el CNP es una opción viable para los recién nacidos de mujeres de bajo riesgo desde que siga el protocolo de selección de las mujeres de bajo riesgo.

RESUMO Objetivo: analisar os fatores associados ao Apgar de quinto minuto menor do que sete de recém-nascidos de mulheres selecionadas para a assistência no Centro de Parto Normal (CPN). Método: estudo descritivo transversal com dados de 9.135 recém-nascidos, coletados entre julho de 2001 e dezembro de 2012. Na análise foi utilizada a apuração de frequências absolutas e relativas das variáveis e análise bivariada mediante o cálculo dos testes de qui-quadrado de Pearson ou exato de Fisher. Resultados: 53 recém-nascidos (0,6%) tiveram Apgar menor que sete no quinto minuto. A análise multivariada encontrou associação positiva entre baixo Apgar e idade gestacional menor que 37 semanas, patologias na gestação e intercorrências no trabalho de parto. A presença do acompanhante foi um fator protetor. Conclusão: o CPN é uma opção viável para recém-nascidos de mulheres de baixo risco desde que o protocolo de seleção das mulheres de baixo risco seja seguido.

Acolher e escutar o silêncio: o cuidado de enfermagem sob aótica da mulher surda durante a gestação, parto e puerpério / Recibir y escuchar el silencio: el cuidado de enfermería desde la perspectiva dela mujer sorda durante el embarazo, parto y puerperio / Welcome and listen to the silence: nursing care from the perspective of deaf woman during pregnancy, childbirth and postpartum

Objective: to identify the perception of the deaf woman regarding nursing care during pregnancy, childbirth and postpartum. Method: this is a exploratory-descriptive study with a qualitative approach, carried out with nine deaf women of a northern city of Minas Gerais. It used a semi-structured interview in which the processing of data was through the Content Analysis. Results: deaf women faced difficulties in receiving assistance from the nursing staff during the perinatal period due to factors such as lack of preparation of professionals in the use of sign language; lack of interpreters in service; speakers who talk too fast; and the use of masks by professionals, making it difficult to read lips. Conclusion: the communication barrier is observed in the interaction between deaf women and health professionals, making it essential that both find ways to interact to ensure improved quality of care.

Objetivo: identificar a percepção da mulher surda quanto aos cuidados de enfermagem durante a gestação, o parto e o puerpério. Método: trata-se de um estudo descritivo, exploratório, com abordagem qualitativa, realizada com nove mulheres surdas de uma cidade do norte de Minas Gerais. Utilizou-se uma entrevista semiestruturada na qual o tratamento dos dados se deu por meio da Análise de Conteúdo. Resultados: as mulheres surdas enfrentaram dificuldades na assistência prestada pela equipe de enfermagem durante o período perinatal devido à fatores como: despreparo dos profissionais quanto ao uso da linguagem de sinais; ausência de intérpretes nos serviços; interlocutores que falam rápido demais; e uso de máscaras pelos profissionais, dificultando a leitura labial. Conclusão: a barreira de comunicação é verificada na interação entre surdas e profissionais de saúde, tornando-se indispensável que ambos encontrem formas de interagir para garantir uma assistência de melhor qualidade.

Objetivo: identificar la percepción de la mujer sorda y la atención de enfermería durante el embarazo, parto y puerperio. Método: se trata de un estudio descriptivo, exploratorio, con un enfoque cualitativo, realizado con nueve mujeres sordas de una ciudad del norte de Minas Gerais. Se utilizó una entrevista semiestructurada en la cual el tratamiento de los datos fue a través del análisis de contenido. Resultados: las mujeres sordas enfrentan dificultades para asistir al personal de enfermería durante el período perinatal debido a factores como la falta de preparación de los profesionales en el uso del lenguaje de signos; falta de intérpretes en servicio; oradores que hablan demasiado rápido; y el uso de máscaras por los profesionales, por lo que es difícil de leer los labios. Conclusión: la barrera de comunicación se verifica en la interacción entre sordos y profesionales de la salud, por lo que es esencial que tanto encontrar maneras de interactuar para garantizar una mejor calidad de la atención.

Associação entre fatores maternos e neonatais e o Apgar em recém-nascidos de risco habitual / Association between maternal and neonatal factors and Apgar in usual risk neonates

Objetivo: verificar associação entre fatores maternos e neonatais e o índice de Apgar <7 aos cinco minutos de vida. Métodos: estudo transversal com 134 recém-nascidos. Para análise dos dados coletados com instrumento elaborado pelos pesquisadores, utilizou-se a descrição das frequências absolutas e relativas e a aplicação dos testes Qui-quadrado ou exato de Fisher. Resultados: do total de recém-nascidos, 63,0% tinham mãe primigesta, 56,0% eram do sexo masculino, 79,0% nasceram de parto normal, 65,0% demandaram oxigênio e 45,0% foram reanimados na sala de parto. Entre as mulheres, 71,0% utilizaram ocitocina. Conclusão: uso de ocitocina, oxigênio e reanimação em sala de parto mostraram associação significativa com Apgar <7 aos cinco minutos de vida. Peso ao nascer, tempo de bolsa rota, eliminação de mecônio, tipo de parto e paridade não se relacionaram ao baixo valor de Apgar. (AU)

[Characteristics of labor and delivery care in three healthcare models within the Unified National Health System in Belo Horizonte, Minas Gerais State, Brazil]. / Características da assistência ao trabalho de parto e parto em três modelos de atenção no SUS, no Município de Belo Horizonte, Minas Gerais, Brasil.

This cross-sectional study of 831 low-risk pregnancies compared the management of labor and delivery in a birthing center, a hospital that had previously won the "Galba de Araújo" Award (for excellence in obstetric and neonatal care), and a standard-protocol maternity facility. The rates for use of ocytocin during labor were 27.9%, 59.5%, and 40.1%, while amniotomy was performed in 67.6%, 73.6%, and 82.2% of the women, respectively. Episiotomy rates were lower in the first two facilities, which have adopted patient-centered obstetric practices (7.2% at the birthing center and 14.8% at the award-winning hospital) as compared to 54.9% at the standard maternity facility. The liberal offer of epidural anesthesia at the awarding-winning hospital resulted in a higher anesthesia rate (54.4%) as compared to the standard facility (7.7%). Forceps delivery and neonatal admission rates were higher in the standard hospital, but there were no differences in mean Apgar or cesarean rates. The findings suggest resistance to selective use of interventions in all three models of obstetric care, although favoring the birthing center as a strategy for controlling interventions during labor and childbirth in low-risk pregnancies, with no resulting harm to the mothers or newborns.

Comparação de modelos de assistência ao parto em hospitais públicos / Comparison of childbirth care models in public hospitals, Brazil

OBJETIVO Comparar os modelos colaborativo e tradicional na assistência ao parto e nascimento. MÉTODOS Estudo transversal realizado com 655 primíparas em quatro hospitais do sistema único de saúde em Belo Horizonte, MG, em 2011 (333 mulheres do modelo colaborativo e 322 do modelo tradicional, incluindo aquelas com trabalho de parto induzido e prematuro). Os dados foram coletados em entrevistas e levantamento de prontuários. Foram aplicados os testes Qui-quadrado para comparação e regressão logística múltipla para determinar associação entre o modelo e os desfechos analisados. RESULTADOS Houve diferenças significativas entre os modelos em relação ao nível de escolaridade e trabalho remunerado. No modelo colaborativo houve menor utilização da ocitocina (50,2% no modelo colaborativo versus 65,5% no modelo tradicional; p < 0,001), da ruptura artificial das membranas (54,3% no modelo colaborativo versus 65,9% no modelo tradicional; p = 0,012) e da taxa de episiotomia (16,1% no modelo colaborativo versus 85,2% no modelo tradicional; p < 0,001), e maior utilização de métodos não farmacológicos para alívio da dor (85,0% no modelo colaborativo versus 78,9% no modelo tradicional; p = 0,042). A associação entre o modelo colaborativo e a redução no uso da ocitocina, da ruptura artificial das membranas e da episiotomia manteve-se após o ajuste para fatores de confundimento. O modelo assistencial não esteve associado a complicações neonatais ou maternas nem à utilização de analgesia de condução. CONCLUSÕES Os resultados sugerem que o modelo colaborativo poderá reduzir as intervenções na assistência ao trabalho de parto e parto com resultados perinatais semelhantes. .

OBJECTIVE To compare collaborative and traditional childbirth care models. METHODS Cross-sectional study with 655 primiparous women in four public health system hospitals in Belo Horizonte, MG, Southeastern Brazil, in 2011 (333 women for the collaborative model and 322 for the traditional model, including those with induced or premature labor). Data were collected using interviews and medical records. The Chi-square test was used to compare the outcomes and multivariate logistic regression to determine the association between the model and the interventions used. RESULTS Paid work and schooling showed significant differences in distribution between the models. Oxytocin (50.2% collaborative model and 65.5% traditional model; p < 0.001), amniotomy (54.3% collaborative model and 65.9% traditional model; p = 0.012) and episiotomy (collaborative model 16.1% and traditional model 85.2%; p < 0.001) were less used in the collaborative model with increased application of non-pharmacological pain relief (85.0% collaborative model and 78.9% traditional model; p = 0.042). The association between the collaborative model and the reduction in the use of oxytocin, artificial rupture of membranes and episiotomy remained after adjustment for confounding. The care model was not associated with complications in newborns or mothers neither with the use of spinal or epidural analgesia. CONCLUSIONS The results suggest that collaborative model may reduce interventions performed in labor care with similar perinatal outcomes. .

Características da assistência ao trabalho de parto e parto em três modelos de atenção no SUS, no Município de Belo Horizonte, Minas Gerais, Brasil / Characteristics of labor and delivery care in three healthcare models within the Unified National Health System in Belo Horizonte, Minas Gerais State, Brazil

Estudo transversal com 831 gestantes, de risco habitual, sobre o manejo do trabalho de parto num Centro de Parto Normal (CPN), num hospital vencedor do título "Galba de Araújo" (HG) e numa maternidade com modelo assistencial prevalente (HP). O uso da ocitocina no CPN foi de 27,9 por cento, no HG 59,5 por cento e no HP 40,1 por cento, enquanto a amniotomia foi realizada em 67,6 por cento, 73,6 por cento e 82,2 por cento das mulheres, respectivamente. A realização da episiotomia foi menor nas modalidades com incorporação de práticas humanizadas: 7,2 por cento no CPN e 14,8 por cento no HG versus 54,9 por cento no HP. A prática de oferta liberal no HG resultou numa taxa de analgesia superior (54,4 por cento) à do HP (7,7 por cento). O percentual de internação dos recém-nascidos e o de parto a fórceps foram mais altas no HP, mas não houve diferenças para o índice de Apgar e para a taxa de cesárea. Os resultados sugerem resistência ao uso seletivo de intervenções em todos os modelos assistenciais, embora favoreçam o CPN como estratégia no controle das intervenções durante o trabalho de parto e parto nas gestantes de risco habitual sem prejuízos para as mulheres e os recém-nascidos.

This cross-sectional study of 831 low-risk pregnancies compared the management of labor and delivery in a birthing center, a hospital that had previously won the "Galba de Araújo" Award (for excellence in obstetric and neonatal care), and a standard-protocol maternity facility. The rates for use of ocytocin during labor were 27.9 percent, 59.5 percent, and 40.1 percent, while amniotomy was performed in 67.6 percent, 73.6 percent, and 82.2 percent of the women, respectively. Episiotomy rates were lower in the first two facilities, which have adopted patient-centered obstetric practices (7.2 percent at the birthing center and 14.8 percent at the award-winning hospital) as compared to 54.9 percent at the standard maternity facility. The liberal offer of epidural anesthesia at the awarding-winning hospital resulted in a higher anesthesia rate (54.4 percent) as compared to the standard facility (7.7 percent). Forceps delivery and neonatal admission rates were higher in the standard hospital, but there were no differences in mean Apgar or cesarean rates. The findings suggest resistance to selective use of interventions in all three models of obstetric care, although favoring the birthing center as a strategy for controlling interventions during labor and childbirth in low-risk pregnancies, with no resulting harm to the mothers or newborns.