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[This corrects the article DOI: 10.1371/journal.pmed.1002220.].
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BACKGROUND: Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the standard therapy for the prevention of postpartum hemorrhage, but it requires cold storage, which is not available in many countries. In a large trial, we compared a novel formulation of heat-stable carbetocin with oxytocin. METHODS: We enrolled women across 23 sites in 10 countries in a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin (at a dose of 100 µg) with oxytocin (at a dose of 10 IU) administered immediately after vaginal birth. Both drugs were kept in cold storage (2 to 8°C) to maintain double-blinding. There were two primary outcomes: the proportion of women with blood loss of at least 500 ml or the use of additional uterotonic agents, and the proportion of women with blood loss of at least 1000 ml. The noninferiority margins for the relative risks of these outcomes were 1.16 and 1.23, respectively. RESULTS: A total of 29,645 women underwent randomization. The frequency of blood loss of at least 500 ml or the use of additional uterotonic agents was 14.5% in the carbetocin group and 14.4% in the oxytocin group (relative risk, 1.01; 95% confidence interval [CI], 0.95 to 1.06), a finding that was consistent with noninferiority. The frequency of blood loss of at least 1000 ml was 1.51% in the carbetocin group and 1.45% in the oxytocin group (relative risk, 1.04; 95% CI, 0.87 to 1.25), with the confidence interval crossing the margin of noninferiority. The use of additional uterotonic agents, interventions to stop bleeding, and adverse effects did not differ significantly between the two groups. CONCLUSIONS: Heat-stable carbetocin was noninferior to oxytocin for the prevention of blood loss of at least 500 ml or the use of additional uterotonic agents. Noninferiority was not shown for the outcome of blood loss of at least 1000 ml; low event rates for this outcome reduced the power of the trial. (Funded by Merck Sharpe & Dohme; CHAMPION Australian New Zealand Clinical Trials Registry number, ACTRN12614000870651 ; EudraCT number, 2014-004445-26 ; and Clinical Trials Registry-India number, CTRI/2016/05/006969 .).
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Ocitócicos/uso terapêutico , Ocitocina/análogos & derivados , Ocitocina/uso terapêutico , Hemorragia Pós-Parto/prevenção & controle , Adulto , Método Duplo-Cego , Estabilidade de Medicamentos , Feminino , Humanos , Injeções Intramusculares , Ocitócicos/efeitos adversos , Ocitocina/efeitos adversos , Gravidez , Risco , Adulto JovemRESUMO
Biological drug products are formulated with excipients to maintain stability over the shelf life of the product. Surfactants are added to the drug product to stabilize air-water interfaces known to induce protein aggregation. Early formulation development is focused on maintaining protein conformation and colloidal stability over the course of the drug product shelf life but rarely considers stability through dose preparation and administration. Specifically, intravenous (IV) bag preparation exposes the therapeutic protein to a different solution environment concurrently diluting the stabilizing excipients that had been added to the drug product formulation. Mixing in IV bags can generate dynamic changes in the air-water interfacial area known to cause protein aggregation if not sufficiently protected. Therefore, understanding the surfactant requirements for drug product end-to-end stability in early formulation development provides critical information for a right-first-time approach to drug product formulation and robust clinical preparation. The goal of these studies was to understand if interfacial properties of proteins could predict surfactant formulation requirements for end-to-end stability. Specifically, the interfacial properties of five proteins were measured in 0.9% saline and 5% dextrose. Furthermore, shaking studies were conducted to identify the minimum surfactant concentration required to prevent subvisible and visible particle formulation in each diluent. The impact of surfactant type and concentration on particle generation and size was explored. A mathematical model was generated to predict the minimum surfactant concentration required to prevent interface-driven aggregation in each diluent based on the change in surface pressure upon exposure of the protein to the interface. The model was tested under typical IV-preparation conditions with experimental output closely matching the model prediction. By employing this model and better understanding the role of surfactants in interfacial stability, drug product development can generate robust end-to-end large molecule formulations across shelf life, dose preparation, and administration.
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Agregados Proteicos/efeitos dos fármacos , Tensão Superficial/efeitos dos fármacos , Tensoativos/química , Adsorção/efeitos dos fármacos , Anticorpos Monoclonais/química , Química Farmacêutica/métodos , Estabilidade de Medicamentos , Excipientes/química , Polissorbatos/química , Conformação Proteica/efeitos dos fármacos , Água/químicaRESUMO
BACKGROUND: Perinatal mortality and morbidity continue to be major global health challenges strongly associated with prematurity and reduced fetal growth, an issue of further interest given the mounting evidence that fetal growth in general is linked to degrees of risk of common noncommunicable diseases in adulthood. Against this background, WHO made it a high priority to provide the present fetal growth charts for estimated fetal weight (EFW) and common ultrasound biometric measurements intended for worldwide use. METHODS AND FINDINGS: We conducted a multinational prospective observational longitudinal study of fetal growth in low-risk singleton pregnancies of women of high or middle socioeconomic status and without known environmental constraints on fetal growth. Centers in ten countries (Argentina, Brazil, Democratic Republic of the Congo, Denmark, Egypt, France, Germany, India, Norway, and Thailand) recruited participants who had reliable information on last menstrual period and gestational age confirmed by crown-rump length measured at 8-13 wk of gestation. Participants had anthropometric and nutritional assessments and seven scheduled ultrasound examinations during pregnancy. Fifty-two participants withdrew consent, and 1,387 participated in the study. At study entry, median maternal age was 28 y (interquartile range [IQR] 25-31), median height was 162 cm (IQR 157-168), median weight was 61 kg (IQR 55-68), 58% of the women were nulliparous, and median daily caloric intake was 1,840 cal (IQR 1,487-2,222). The median pregnancy duration was 39 wk (IQR 38-40) although there were significant differences between countries, the largest difference being 12 d (95% CI 8-16). The median birthweight was 3,300 g (IQR 2,980-3,615). There were differences in birthweight between countries, e.g., India had significantly smaller neonates than the other countries, even after adjusting for gestational age. Thirty-one women had a miscarriage, and three fetuses had intrauterine death. The 8,203 sets of ultrasound measurements were scrutinized for outliers and leverage points, and those measurements taken at 14 to 40 wk were selected for analysis. A total of 7,924 sets of ultrasound measurements were analyzed by quantile regression to establish longitudinal reference intervals for fetal head circumference, biparietal diameter, humerus length, abdominal circumference, femur length and its ratio with head circumference and with biparietal diameter, and EFW. There was asymmetric distribution of growth of EFW: a slightly wider distribution among the lower percentiles during early weeks shifted to a notably expanded distribution of the higher percentiles in late pregnancy. Male fetuses were larger than female fetuses as measured by EFW, but the disparity was smaller in the lower quantiles of the distribution (3.5%) and larger in the upper quantiles (4.5%). Maternal age and maternal height were associated with a positive effect on EFW, particularly in the lower tail of the distribution, of the order of 2% to 3% for each additional 10 y of age of the mother and 1% to 2% for each additional 10 cm of height. Maternal weight was associated with a small positive effect on EFW, especially in the higher tail of the distribution, of the order of 1.0% to 1.5% for each additional 10 kg of bodyweight of the mother. Parous women had heavier fetuses than nulliparous women, with the disparity being greater in the lower quantiles of the distribution, of the order of 1% to 1.5%, and diminishing in the upper quantiles. There were also significant differences in growth of EFW between countries. In spite of the multinational nature of the study, sample size is a limiting factor for generalization of the charts. CONCLUSIONS: This study provides WHO fetal growth charts for EFW and common ultrasound biometric measurements, and shows variation between different parts of the world.
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Antropometria , Desenvolvimento Fetal , Peso Fetal , Adulto , Feminino , Saúde Global , Humanos , Estudos Longitudinais , Masculino , Gravidez , Estudos Prospectivos , Valores de Referência , Ultrassonografia , Adulto JovemRESUMO
[This corrects the article DOI: 10.1371/journal.pmed.1002220.].
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BACKGROUND: Every year millions of women around the world suffer from pregnancy, childbirth and postpartum complications. Women who survive the most serious clinical conditions are regarded as to have experienced a severe acute maternal complication called maternal near miss (MNM). Information about MNM cases may complement the data collected through the analysis of maternal death, and was proposed as a helpful tool to identify strengths and weaknesses of health systems in relation to maternal health care. The purpose of this study is to evaluate the performance of a systematized form to detect severe maternal outcomes (SMO) in 20 selected maternity hospitals from Latin America (LAC). METHODS: Cross-sectional study. Data were obtained from analysis of hospital records for all women giving birth and all women who had a SMO in the selected hospitals. Univariate and multivariate adjusted logistic regression models were used to assess the predictive ability of different conditions to identify SMO cases. In parallel, external auditors were hired for reviewing and reporting the total number of discharges during the study period, in order to verify whether health professionals at health facilities identified all MNM and Potentially life-threatening condition (PLTC) cases. RESULTS: Twenty hospitals from twelve LAC were initially included in the study and based on the level of coverage, 11 hospitals with a total of 3,196records were included for the final analysis. The incidence of SMO and MNM outcomes was 12.9 and 12.3 per 1,000 live births, respectively. The ratio of MNM to maternal death was 19 to 1, with a mortality index of 5.1 %. Both univariate and multivariate analysis showed a good performance for a number of clinical and laboratory conditions to predict a severe maternal outcome, however, their clinical relevance remains to be confirmed. Coherence between health professionals and external auditors to identify SMO was high (around 100 %). CONCLUSIONS: The form tested, was well accepted by health professionals and was capable of identifying 100 % of MNM cases and more than 99 % of PLTC variables. Altered state of consciousness, oliguria, placenta accrete, pulmonary edema, and admission to Intensive Care Unit have a high (LR+ ≥80) capacity to anticipate a SMO.
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Maternidades/estatística & dados numéricos , Mortalidade Materna , Near Miss/estatística & dados numéricos , Complicações na Gravidez/epidemiologia , Estudos Transversais , Coleta de Dados/métodos , Feminino , Humanos , Lactente , Mortalidade Infantil , Recém-Nascido , América Latina/epidemiologia , Serviços de Saúde Materno-Infantil , Prontuários Médicos , Complicações do Trabalho de Parto/epidemiologia , Gravidez , Resultado da Gravidez/epidemiologia , Nascimento Prematuro/epidemiologia , Fatores de RiscoRESUMO
INTRODUCTION: Abortion-related complications are a significant cause of morbidity and mortality among women in many Latin American and Caribbean (LAC) countries. The objective of this study was to characterise abortion-related complication severity, describe the management of these complications and report women's experiences with abortion care in selected countries of the Americas region. METHODS: This is a cross-sectional study of 70 health facilities across six countries in the region. We collected data on women's characteristics including socio-demographics, obstetric history, clinical information, management procedures and using Audio Computer-Assisted Self-Interviewing (ACASI) survey the experience of abortion care. Descriptive bivariate analysis was performed for women's characteristics, management of complications and reported experiences of abortion care by severity of complications, organised in five hierarchical mutually exclusive categories based on indicators present at assessment. Generalised linear estimation models were used to assess the association between women's characteristics and severity of complications. RESULTS: We collected data on 7983 women with abortion-related complications. Complications were classified as mild (46.3%), moderate (49.5%), potentially life-threatening (3.1%), near-miss cases (1.1%) and deaths (0.2%). Being single, having a gestational age of ≥13 weeks and having expelled products of conception before arrival at the facility were significantly associated with experiencing severe maternal outcomes compared with mild complications.Management of abortion-related complications included both uterotonics and uterine evacuation for two-thirds of the women while one-third received uterine evacuation only. Surgical uterine evacuation was performed in 93.2% (7437/7983) of women, being vacuum aspiration the most common one (5007/7437, 67.4%).Of the 327 women who completed the ACASI survey, 16.5% reported having an induced abortion, 12.5% of the women stated that they were not given explanations regarding their care nor were able to ask questions during their examination and treatment with percentages increasing with the severity of morbidity. CONCLUSIONS: This is one of the first studies using a standardised methodology to measure severity of abortion-related complications and women's experiences with abortion care in LAC. Results aim to inform policies and programmes addressing sexual and reproductive rights and health in the region.
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Aborto Induzido , Aborto Induzido/efeitos adversos , Região do Caribe , Estudos Transversais , Feminino , Humanos , Lactente , América Latina/epidemiologia , Morbidade , Gravidez , Organização Mundial da SaúdeRESUMO
OBJECTIVE: A dipslide is a plastic paddle coated with agar that is attached to a plastic cap that screws onto a sterile plastic vial. Our objective was to estimate the diagnostic accuracy of the dipslide culture technique to detect asymptomatic bacteriuria during pregnancy and to evaluate the accuracy of nitrate and leucocyte esterase dipslides for screening. METHODS: This was an ancillary study within a trial comparing single-day with 7-day therapy in treating asymptomatic bacteriuria. Clean-catch midstream samples were collected from pregnant women seeking routine care. Positive and negative likelihood ratios and sensitivity and specificity for the culture-based dipslide to detect and chemical dipsticks (nitrites, leukocyte esterase, or both) to screen were estimated using traditional urine culture as the "gold standard." RESULTS: : A total of 3,048 eligible pregnant women were screened. The prevalence of asymptomatic bacteriuria was 15%, with Escherichia coli the most prevalent organism. The likelihood ratio for detecting asymptomatic bacteriuria with a positive dipslide test was 225 (95% confidence interval [CI] 113-449), increasing the probability of asymptomatic bacteriuria to 98%; the likelihood ratio for a negative dipslide test was 0.02 (95% CI 0.01-0.05), reducing the probability of bacteriuria to less than 1%. The positive likelihood ratio of leukocyte esterase and nitrite dipsticks (when both or either one was positive) was 6.95 (95% CI 5.80-8.33), increasing the probability of bacteriuria to only 54%; the negative likelihood ratio was 0.50 (95% CI 0.45-0.57), reducing the probability to 8%. CONCLUSION: A pregnant woman with a positive dipslide test is very likely to have a definitive diagnosis of asymptomatic bacteriuria, whereas a negative result effectively rules out the presence of bacteriuria. Dipsticks that measure nitrites and leukocyte esterase have low sensitivity for use in screening for asymptomatic bacteriuria during gestation. CLINICAL TRIAL REGISTRATION: ISRCTN, isrctn.org, 1196608 LEVEL OF EVIDENCE: II.
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Bacteriúria/diagnóstico , Complicações Infecciosas na Gravidez/diagnóstico , Kit de Reagentes para Diagnóstico , Hidrolases de Éster Carboxílico/urina , Contagem de Colônia Microbiana , Feminino , Humanos , Funções Verossimilhança , Nitritos/urina , Valor Preditivo dos Testes , Gravidez , Urinálise , Organização Mundial da SaúdeRESUMO
Cluster-based studies involving aggregate units such as hospitals or medical practices are increasingly being used in healthcare evaluation. An important characteristic of such studies is the presence of intracluster correlation, typically quantified by the intracluster correlation coefficient (ICC). Sample size calculations for cluster-based studies need to account for the ICC, or risk underestimating the sample size required to yield the desired levels of power and significance. In this article, we present values for ICCs that were obtained from data on 97,095 pregnancies and 98,072 births taking place in a representative sample of 120 hospitals in eight Latin American countries. We present ICCs for 86 variables measured on mothers and newborns from pregnancy to the time of hospital discharge, including 'process variables' representing actual medical care received for each mother and newborn. Process variables are of primary interest in the field of implementation research. We found that overall, ICCs ranged from a minimum of 0.0003 to a maximum of 0.563 (median 0.067). For maternal and newborn outcome variables, the median ICCs were 0.011 (interquartile range 0.007-0.037) and 0.054 (interquartile range 0.013-0.075) respectively; however, for process variables, the median was 0.161 (interquartile range 0.072-0.328). Thus, we confirm previous findings that process variables tend to have higher ICCs than outcome variables. We demonstrate that ICCs generally tend to increase with higher prevalences (close to 0.5). These results can help researchers calculate the required sample size for future research studies in maternal and perinatal health.
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Pesquisa sobre Serviços de Saúde/estatística & dados numéricos , Bem-Estar Materno , Avaliação de Processos e Resultados em Cuidados de Saúde/estatística & dados numéricos , Assistência Perinatal , Análise por Conglomerados , Feminino , Pesquisa sobre Serviços de Saúde/métodos , Humanos , Recém-Nascido , Gravidez , Organização Mundial da SaúdeRESUMO
BACKGROUND: Caesarean delivery rates continue to increase worldwide. Our aim was to assess the association between caesarean delivery and pregnancy outcome at the institutional level, adjusting for the pregnant population and institutional characteristics. METHODS: For the 2005 WHO global survey on maternal and perinatal health, we assessed a multistage stratified sample, comprising 24 geographic regions in eight countries in Latin America. We obtained individual data for all women admitted for delivery over 3 months to 120 institutions randomly selected from of 410 identified institutions. We also obtained institutional-level data. FINDINGS: We obtained data for 97,095 of 106,546 deliveries (91% coverage). The median rate of caesarean delivery was 33% (quartile range 24-43), with the highest rates of caesarean delivery noted in private hospitals (51%, 43-57). Institution-specific rates of caesarean delivery were affected by primiparity, previous caesarean delivery, and institutional complexity. Rate of caesarean delivery was positively associated with postpartum antibiotic treatment and severe maternal morbidity and mortality, even after adjustment for risk factors. Increase in the rate of caesarean delivery was associated with an increase in fetal mortality rates and higher numbers of babies admitted to intensive care for 7 days or longer even after adjustment for preterm delivery. Rates of preterm delivery and neonatal mortality both rose at rates of caesarean delivery of between 10% and 20%. INTERPRETATION: High rates of caesarean delivery do not necessarily indicate better perinatal care and can be associated with harm.
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Cesárea/estatística & dados numéricos , Coleta de Dados/métodos , Complicações na Gravidez/cirurgia , Resultado da Gravidez , Adolescente , Adulto , Anestesia Obstétrica/estatística & dados numéricos , Cesárea/tendências , Feminino , Humanos , Lactente , Mortalidade Infantil , América Latina , Mortalidade Materna , Bem-Estar Materno , GravidezRESUMO
OBJECTIVE: Preeclampsia, gestational hypertension, and unexplained intrauterine growth restriction may have similar determinants and consequences. In this study, we compared determinants and perinatal outcomes associated with these obstetric conditions. STUDY DESIGN: We analyzed 39,615 pregnancies (data from the WHO Antenatal Care Trial), of which 2.2% were complicated by preeclampsia, 7.0% by gestational hypertension, and 8.1% by unexplained intrauterine growth restriction (ie, not associated with maternal smoking, maternal undernutrition, preeclampsia, gestational hypertension, or congenital malformations). We compared the risk factors associated with these groups. Fetal death, preterm delivery, and severe neonatal morbidity and mortality were the primary outcomes. Logistic regression analyses were adjusted for study site, socioeconomic status, and (if appropriate) birth weight and gestational age. RESULTS: Diabetes, renal or cardiac disease, previous preeclampsia, urinary tract infection, high maternal age, twin pregnancy, and obesity increased the risk of both hypertensive conditions. Previous large-for-age birth, reproductive tract surgery, antepartum hemorrhage and reproductive tract infection increased the risk for gestational hypertension only. Independent of maternal age, primiparity was a risk factor only for preeclampsia. Both preeclampsia and gestational hypertension were associated with increased risk for fetal death and severe neonatal morbidity and mortality. Mothers with preeclampsia compared with those with unexplained intrauterine growth restriction were more likely to have a history of diabetes, renal or cardiac disease, chronic hypertension, previous preeclampsia, body mass index more than 30 kg/cm2, urinary tract infection and extremes of maternal age. Conversely, unexplained intrauterine growth restriction was associated with higher risk of low birth weight in previous pregnancies, but not with previous preeclampsia. Both conditions increased the risk for perinatal outcomes independently but preeclampsia was associated with considerable higher risk. CONCLUSION: Preeclampsia and gestational hypertension shared many risk factors, although there are differences that need further evaluation. Both conditions significantly increased morbidity and mortality. Conversely, preeclampsia and unexplained intrauterine growth restriction, often assumed to be related to placental insufficiency, seem to be independent biologic entities.
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Retardo do Crescimento Fetal , Hipertensão Induzida pela Gravidez , Pré-Eclâmpsia , Feminino , Retardo do Crescimento Fetal/epidemiologia , Retardo do Crescimento Fetal/etiologia , Humanos , Hipertensão Induzida pela Gravidez/epidemiologia , Hipertensão Induzida pela Gravidez/etiologia , Recém-Nascido , Pré-Eclâmpsia/epidemiologia , Pré-Eclâmpsia/etiologia , Gravidez , Resultado da Gravidez , Fatores de RiscoRESUMO
OBJECTIVE: Our aim was to document the differential neonatal morbidity and intrapartum and neonatal mortality of subgroups of preterm delivery. METHODS: This analysis included 38,319 singleton pregnancies, of which 3,304 (8.6%) were preterm deliveries (less than 37 completed weeks) enrolled in the World Health Organization randomized trial of a new antenatal care model. We classified them as preterm deliveries after spontaneous initiation of labor, either with or without maternal obstetric and medical complications; preterm deliveries after prelabor spontaneous rupture of amniotic membranes (PROM), either with or without obstetric and medical complications; and medically indicated preterm deliveries with maternal obstetric and medical complications. Severe neonatal morbidity and neonatal mortality were the primary outcomes. RESULTS: Fifty-six percent of all preterm deliveries were spontaneous, without maternal complications. Small for gestational age was increased only among the medically indicated preterm delivery group (22.3%). Very early preterm delivery (less than 32 weeks of gestation) was highest among PROM with complications (37%). For intrapartum fetal death and neonatal death, after adjusting by gestational age and other confounding variables, we found that the obstetric and medical complications preceding preterm delivery predicted the different risk levels. Conversely, for severe neonatal morbidity the clinical presentation, ie, PROM or medically indicated, predicted the increased risk. CONCLUSION: There are differential neonatal outcomes among preterm deliveries according to clinical presentation, pregnancy complications, gestational age at delivery, and its association with small for gestational age. This syndromic nature of the condition should be considered if preterm delivery is to be fully understood and thus reduced.
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Trabalho de Parto Prematuro , Resultado da Gravidez , Adolescente , Adulto , Feminino , Ruptura Prematura de Membranas Fetais/complicações , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Recém-Nascido Pequeno para a Idade Gestacional , Gravidez , SíndromeRESUMO
OBJECTIVE: To assess the risks and benefits associated with caesarean delivery compared with vaginal delivery. DESIGN: Prospective cohort study within the 2005 WHO global survey on maternal and perinatal health. SETTING: 410 health facilities in 24 areas in eight randomly selected Latin American countries; 123 were randomly selected and 120 participated and provided data PARTICIPANTS: 106,546 deliveries reported during the three month study period, with data available for 97,095 (91% coverage). MAIN OUTCOME MEASURES: Maternal, fetal, and neonatal morbidity and mortality associated with intrapartum or elective caesarean delivery, adjusted for clinical, demographic, pregnancy, and institutional characteristics. RESULTS: Women undergoing caesarean delivery had an increased risk of severe maternal morbidity compared with women undergoing vaginal delivery (odds ratio 2.0 (95% confidence interval 1.6 to 2.5) for intrapartum caesarean and 2.3 (1.7 to 3.1) for elective caesarean). The risk of antibiotic treatment after delivery for women having either type of caesarean was five times that of women having vaginal deliveries. With cephalic presentation, there was a trend towards a reduced odds ratio for fetal death with elective caesarean, after adjustment for possible confounding variables and gestational age (0.7, 0.4 to 1.0). With breech presentation, caesarean delivery had a large protective effect for fetal death. With cephalic presentation, however, independent of possible confounding variables and gestational age, intrapartum and elective caesarean increased the risk for a stay of seven or more days in neonatal intensive care (2.1 (1.8 to 2.6) and 1.9 (1.6 to 2.3), respectively) and the risk of neonatal mortality up to hospital discharge (1.7 (1.3 to 2.2) and 1.9 (1.5 to 2.6), respectively), which remained higher even after exclusion of all caesarean deliveries for fetal distress. Such increased risk was not seen for breech presentation. Lack of labour was a risk factor for a stay of seven or more days in neonatal intensive care and neonatal mortality up to hospital discharge for babies delivered by elective caesarean delivery, but rupturing of membranes may be protective. CONCLUSIONS: Caesarean delivery independently reduces overall risk in breech presentations and risk of intrapartum fetal death in cephalic presentations but increases the risk of severe maternal and neonatal morbidity and mortality in cephalic presentations.
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Cesárea/estatística & dados numéricos , Cesárea/efeitos adversos , Comportamento de Escolha , Feminino , Morte Fetal/etiologia , Tamanho das Instituições de Saúde , Humanos , Mortalidade Infantil , Recém-Nascido , Tempo de Internação , Gravidez , Resultado da Gravidez , Estudos Prospectivos , Fatores de RiscoRESUMO
BACKGROUND: The umbilical cord is usually clamped immediately after birth. There is no sound evidence to support this approach, which might deprive the newborn of some benefits such as an increase in iron storage. OBJECTIVES: We sought to determine the effect of timing of cord clamping on neonatal venous hematocrit and clinical outcome in term newborns and maternal postpartum hemorrhage. METHODS: This was a randomized, controlled trial performed in 2 obstetrical units in Argentina on neonates born at term without complications to mothers with uneventful pregnancies. After written parental consents were obtained, newborns were randomly assigned to cord clamping within the first 15 seconds (group 1), at 1 minute (group 2), or at 3 minutes (group 3) after birth. The infants' venous hematocrit value was measured 6 hours after birth. RESULTS: Two hundred seventy-six newborns were recruited. Mean venous hematocrit values at 6 hours of life were 53.5% (group 1), 57.0% (group 2), and 59.4% (group 3). Statistical analyses were performed, and results were equivalent among groups because the hematocrit increase in neonates with late clamping was within the prespecified physiologic range. The prevalence of hematocrit at <45% (anemia) was significantly lower in groups 2 and 3 than in group 1. The prevalence of hematocrit at >65% was similar in groups 1 and 2 (4.4% and 5.9%, respectively) but significantly higher in group 3 (14.1%) versus group 1 (4.4%). There were no significant differences in other neonatal outcomes and in maternal postpartum hemorrhage. CONCLUSIONS: Delayed cord clamping at birth increases neonatal mean venous hematocrit within a physiologic range. Neither significant differences nor harmful effects were observed among groups. Furthermore, this intervention seems to reduce the rate of neonatal anemia. This practice has been shown to be safe and should be implemented to increase neonatal iron storage at birth.
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Parto Obstétrico/métodos , Hematócrito , Recém-Nascido/sangue , Cordão Umbilical , Adulto , Bilirrubina/sangue , Constrição , Feminino , Humanos , Hemorragia Pós-Parto/diagnóstico , Gravidez , Fatores de Tempo , VeiasRESUMO
Las complicaciones maternas agudas graves (CMAG), cuadros críticos que evolucionan hacia la sobrevida, comparten características con las muertes maternas y pueden complementarla información necesaria para el análisis. OBJETIVO: Evaluar la incidencia y el manejo de las CMAG maternas asociadas con la mortalidad materna y neonatal en maternidades públicas de las provincias de Corrientes y Santa Fe. MÉTODOS: Se realizó un estudio de corte transversal. Se relevó la incidencia y el manejo de las CMAG asociadas con la mortalidad materna y neonatal en maternidades públicas de Corrientes y Santa Fe durante tres meses. Se evaluó la disponibilidad y el uso de intervenciones preventivas y terapéuticas. RESULTADOS: Se incluyó a 6.121 mujeres de 3 maternidades de Corrientes y 10 de Santa Fe. Hubo condiciones potencialmente fatales en 755 (12,3%) y CMAG en 28 (0,5%). El sulfato de magnesio se utilizó en todas las eclampsias, con elevado uso de uterotónicos para la prevención de la hemorragia posparto. La cobertura con corticoides antenatales fue menor a la esperada. En dos tercios de los casos, las complicaciones se iniciaron antes de la llegada al hospital o durante las primeras 24 horas. CONCLUSIONES: El monitoreo de las CMAG maternas permite conocer las incidencias locales y los patrones de mortalidad y morbilidad severa materna, así como las fortalezas y debilidades en los sistemas de referencia y la correcta utilización de las intervenciones clínicas y los sistemas de salud...
Severe maternal acute complications (SMAC), critical situations evolving to survival, share some characteristics with maternal deaths and can provide complementary information for the analysis. OBJECTIVE: To evaluate the incidence and management of SMAC associated with maternal and neonatal mortality in public health facilities of Corrientes and Santa Fe provinces. METHODS: A cross-sectional study was conducted. It assessed the incidence and management of SMAC associated with maternal and neonatal mortality in public hospitals of Corrientes and Santa Fe provinces during a three-month period. Availability and use of prophylactic and therapeutic interventions were also evaluated. RESULTS: A total of 6121 women from 3 hospitals in Corrientes and 10 in SantaFe were included. Life-threatening conditions were found in 755 cases (12.3%) and SMAC in 28 (0.5%). Magnesium sulfate was given for all eclampsia cases, with a high use of uterotonics for prevention of postpartum hemorrhage. The treatment with antenatal corticosteroids was lower than expected. In two thirds of the cases, complications started before hospital admission or during the first 24 hours. CONCLUSIONS: The monitoring of maternal SAC allows to know not only the local incidences and patterns of severe maternal morbidity and mortality, but also the strengths and weaknesses in the referral systems and the correct use of clinical and health system interventions...