RESUMEN
INTRODUCTION: It is poorly understood if there are specific ages at which adverse outcomes during pregnancy and childbirth start to increase (threshold-ages). The purpose of this study was to examine at which maternal ages the use of maternity care and the risks for adverse maternal and infant outcomes increase. MATERIAL AND METHODS: National data from the Finnish Medical Birth Register including all first-time mothers aged 20 years or over with singleton pregnancies in 2005-2014 were analyzed (n = 228 348). Odds ratios for each outcome at different ages were calculated by logistic regression, using women aged 20-24 (n = 56 282) as the reference and adjusting for socioeconomic position and urbanity of residence. The threshold-age was defined as the first significant adjusted odds ratio after which the risk remained significant. RESULTS: The threshold-ages for use of maternity care varied from 25 years for cesarean section (OR 1.08, 95% CI 1.03-1.14) to 38 years for having 16 or more antenatal visits (1.13, 1.04-1.21). Four threshold-ages were found for maternal health outcomes: 25 years for gestational diabetes (OR 1.15, 1.09-1.23), 27 years for placenta previa (OR 1.75, 1.11-2.75), 33 years for gestational hypertension (1.14, 1.03-1.27), and 38 years for preeclampsia (OR 1.48, 1.12-1.96). The threshold-ages for infant health outcomes varied from 28 years for preterm birth (37 weeks, OR 1.10, 1.02-1.19) to 36 years for perinatal mortality (OR 2.10, 1.44-3.07). CONCLUSIONS: Different threshold-ages were identified. Most adverse outcomes occurred earlier than the traditional cut-off ages for high risk pregnancy, which have been set at 35 or 40 years.
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Recién Nacido de Bajo Peso , Edad Materna , Mortalidad Perinatal , Complicaciones del Embarazo/etiología , Adulto , Cesárea/estadística & datos numéricos , Femenino , Finlandia/epidemiología , Humanos , Recién Nacido , Modelos Logísticos , Persona de Mediana Edad , Oportunidad Relativa , Embarazo , Complicaciones del Embarazo/epidemiología , Sistema de Registros , Factores de RiesgoRESUMEN
BACKGROUND: In low- and middle-income countries, many women continue working later into pregnancy. In our recent study on some areas in rural China, most women stopped working already during the first trimester (≤3 months) of pregnancy. In this paper we aimed to explore whether stopping work during early pregnancy has changed over an 8 year period (between 2001-03 and 2009); we also studied whether the reasons for stopping work early were the same in the two time periods. METHODS: A population-based cross-sectional survey with a representative sample of new mothers was carried out in one rural county in Anhui Province in 2001-03 (N = 1479 respondents) and in two other rural counties in 2009 (N = 1574 respondents). Both surveys were used to evaluate prenatal care interventions not related to work behavior. The surveys targeted all women who had recently given birth. Multilevel logistic regression analysis was used to examine the determinants of work behavior in the two time periods. RESULTS: There was a big change in the working behavior between the two survey years: in the period 2001-03 6 % and in 2009, 53 % of pregnant women stopped working at ≤3 months (percentage change 839, 95 % CI -15.90 to 1694.49). In 2001-03, 30 % and in 2009, 23 % of pregnant women worked the same as before pregnancy (percentage change -22.30, 95 % CI -90.28 to 45.68). In both time periods women with two children were less likely to stop work at ≤3 months of pregnancy. Non-farmers were more likely in 2001-03 but less likely in 2009 to stop work at ≤3 months of pregnancy. Women with medium township-level income were more likely to maintain the same level of work as before pregnancy in 2001-03, while in 2009 women with high township-level income were less likely to work the same. CONCLUSION: Stopping work very early during pregnancy appeared to have become very common from 2001-3 to 2009 in rural Anhui, China and was not explained by women's background characteristics.
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Mujeres Embarazadas/psicología , Población Rural/tendencias , Trabajo/psicología , Adulto , China/epidemiología , China/etnología , Estudios Transversales , Femenino , Humanos , Embarazo , Mujeres Embarazadas/etnología , Atención Prenatal/psicología , Atención Prenatal/estadística & datos numéricos , Población Rural/estadística & datos numéricos , Factores Socioeconómicos , Encuestas y CuestionariosRESUMEN
AIM: The increase in maternal age has been well documented in Western societies, but information on paternal age trends is scarce. The aim of this study was to investigate changes in age and other background characteristics of first-time fathers in Finland in the period 1987-2009. MATERIALS AND METHODS: A random 60% sample of first-time fathers in each year from 1987 to 2009 was obtained from Statistics Finland (n=344,529). Five-year intervals were used (three years in 1987-1989). Sociodemographic characteristics of older first-time fathers (⩾40 years) were compared over time using logistic regression. In the logistic regression, immigrants were excluded from the study population as they may have had children before migrating to Finland. RESULTS: The mean age of first-time fathers increased from 28.7 to 30.4 years in 1987-2009. The change was greatest in the Capital Region and smallest in Northern and Eastern Finland. Fatherhood at the age of ⩾40 years doubled from 3.1% to 6.8%. From 2005 to 2009, men who lived in rural areas and the Capital Region, had a long education, were divorced or widowed, had been born in a rural area and were native Finnish speakers, were more likely than other men to be old when they became fathers. CONCLUSIONS DURING THE STUDY PERIOD, THE AVERAGE AGE OF FIRST-TIME FATHERS INCREASED BY TWO YEARS FURTHER STUDIES ARE NEEDED TO EXAMINE WHETHER DELAYS IN FIRST-TIME FATHERHOOD AFFECT FERTILITY, CHILD HEALTH AND THE USE OF SOCIAL AND HEALTH SERVICES.
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Padre/estadística & datos numéricos , Edad Paterna , Adulto , Finlandia , Geografía , Humanos , Masculino , Persona de Mediana Edad , Factores Socioeconómicos , Adulto JovenRESUMEN
BACKGROUND: The aim of this paper is to compare common features and variation in the work of research ethics committees (RECs) in Finland to three other countries - England, Canada, the United States of America (USA) - in the late 2000s. METHODS: Several approaches and data sources were used, including semi- or unstructured interviews of experts, documents, previous reports, presentations in meetings and observations. A theoretical framework was created and data from various sources synthesized. RESULTS: In Finland, RECs were regulated by a medical research law, whereas in the other countries many related laws and rules guided RECs; drug trials had specific additional rules. In England and the USA, there was a REC control body. In all countries, members were voluntary and included lay-persons, and payment arrangements varied. Patient protection was the main ethics criteria, but other criteria (research advancement, availability of results, payments, detailed fulfilment of legislation) varied. In all countries, RECs had been given administrative duties. Variations by country included the mandate, practical arrangements, handling of multi-site research, explicitness of proportionate handlings, judging scientific quality, time-limits for decisions, following of projects, role in institute protection, handling conflicts of interests, handling of projects without informed consent, and quality assurance research. The division of work between REC members and secretariats varied in checking of formalities. In England, quality assurance of REC work was thorough, fairly thorough in the USA, and not performed in Finland. CONCLUSIONS: The work of RECs in the four countries varied notably. Various deficiencies in the system require action, for which international comparison can provide useful insights.
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Investigación Biomédica/ética , Investigación Biomédica/organización & administración , Comités de Ética en Investigación/organización & administración , Investigación Biomédica/legislación & jurisprudencia , Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/legislación & jurisprudencia , Comparación Transcultural , Comités de Ética en Investigación/legislación & jurisprudencia , Humanos , Difusión de la Información , Entrevistas como Asunto , Estudios Multicéntricos como Asunto/ética , Estudios Multicéntricos como Asunto/legislación & jurisprudencia , Seguridad del Paciente/legislación & jurisprudencia , Control de Calidad , Factores de TiempoRESUMEN
Observational studies suggest that high iron intake during pregnancy is associated with the risk of gestational diabetes. As such studies are prone to bias, we re-analysed data from a randomised controlled trial of iron supplementation to see whether it supports the risk found in observational studies. The trial was conducted in primary health care setting in five municipalities in Finland in 1985-1986. The participants were 2944 women (95% of pregnant women in the area) who were randomly allocated either to (1) the selective iron group (elemental iron 50 mg twice a day only if diagnosed as anaemic, continuing until their haemoglobin increased to 110 g L(-1)) or (2) the routine iron group (elemental iron 100 mg day(-1) throughout the pregnancy regardless of haemoglobin level). The numbers of women in the analyses were 1358 and 1336, respectively. The main outcome measure was a composite variable including any glucose intolerance-related outcome (e.g. glucosuria, gestational diabetes, large-for-gestational-age child) in mothers' or children's patient records during pregnancy and post-partum. There were no statistically significant differences in the incidence of the primary outcome between the selective iron and the routine iron groups (13.0 vs. 11.0%, P = 0.12). The most common outcome was large-for-gestational-age calculated from children's hospital data (8.3 vs. 8.2%, P = 0.95). The results were mainly similar when stratified by the mothers' baseline haemoglobin level, body mass index or gestational weight gain. Routine iron supplementation throughout pregnancy did not increase the risk of glucose intolerance during pregnancy. The results need to be confirmed in future trials.
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Anemia Ferropénica/dietoterapia , Diabetes Gestacional/etiología , Suplementos Dietéticos/efectos adversos , Hierro de la Dieta/efectos adversos , Fenómenos Fisiologicos Nutricionales Maternos , Adulto , Peso al Nacer , Diabetes Gestacional/epidemiología , Diabetes Gestacional/fisiopatología , Femenino , Macrosomía Fetal/epidemiología , Macrosomía Fetal/etiología , Finlandia/epidemiología , Estudios de Seguimiento , Intolerancia a la Glucosa/epidemiología , Intolerancia a la Glucosa/etiología , Intolerancia a la Glucosa/fisiopatología , Humanos , Incidencia , Recién Nacido , Hierro de la Dieta/uso terapéutico , Masculino , Embarazo , Factores de Riesgo , Aumento de Peso , Adulto JovenRESUMEN
After identification of an important research question and selection of an appropriate study design, waste can arise from the regulation, governance, and management of biomedical research. Obtaining regulatory and governance approval has become increasingly burdensome and disproportionate to the conceivable risks to research participants. Regulation and governance involve interventions that are assumed to be justified in the interests of patients and the public, but they can actually compromise these interests. Inefficient management of the procedural conduct of research is wasteful, especially if it results in poor recruitment and retention of participants in well designed studies addressing important questions. These sources of waste can be minimised if the following four recommendations are addressed. First, regulators should use their influence to reduce other causes of waste and inefficiency in research. Second, regulators and policy makers should work with researchers, patients, and health professionals to streamline and harmonise the laws, regulations, guidelines, and processes that govern whether and how research can be done, and ensure that they are proportionate to the plausible risks associated with the research. Third, researchers and research managers should increase the efficiency of recruitment, retention, data monitoring, and data sharing in research through use of research designs known to reduce inefficiencies, and further research should be done to learn how efficiency can be increased. Finally, everyone, particularly those responsible for health-care systems, should promote integration of research into everyday clinical practice. Regulators and researchers should monitor adherence to each of these recommendations and publish metrics.
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Investigación Biomédica/normas , Bioética , Investigación Biomédica/legislación & jurisprudencia , Investigación Biomédica/organización & administración , Proyectos de Investigación/normasRESUMEN
BACKGROUND: The Caesarean section (C-section) rate is used as an indicator for availability and utilization of life-saving obstetric services. The purpose of the present study was to explore changes in C-section rates between 1995 and 2011 by area, place of delivery and maternal socioeconomic factors in Mozambique. METHODS: Cross-sectional data from the Demographic and Health Surveys conducted in Mozambique in 1997, 2003 and 2011 were used, including women having a live birth within 3 years prior to the survey. Descriptive statistics and logistic regressions were used to identify factors associated with having a C-section. RESULTS: The C-section rate decreased slightly from 2.5% in 1995-1997 to 2.1% in 2001-2003 and then increased to 4.7% in 2009-2011. In 2009-2011, C-section rates ranged in urban areas from 4.6% in the northern region to 12.2% in the southern region and in rural areas from 1.6% in the northern region to 3.9% in the southern region. 12.3% of the richest women had had a C-section, compared to 1.7% of the poorest women. C-sections were the most common at public hospitals (12.6% in 2009-2011), but C-sections at health centers increased from the second to the third period. The likelihood of having a C-section was associated with living in urban areas and in the southern region, having a formal education and living in a rich household, even adjusting for age and parity (and study periods). The strongest relationship was for the richest household wealth quintile [OR (95% CI): 9.8 (6.3-15.3)]. The highest rate (20.6%) was found among the richest women giving birth at public hospitals in the southern region in 2009-2011. CONCLUSION: In Mozambique, underuse of C-section was likely among the poor and in rural areas, but overuse in the most advantaged groups seemed to be emerging.
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Cesárea/estadística & datos numéricos , Cesárea/tendencias , Centros Comunitarios de Salud/estadística & datos numéricos , Hospitales Públicos/estadística & datos numéricos , Población Rural/estadística & datos numéricos , Población Urbana/estadística & datos numéricos , Adolescente , Adulto , Centros Comunitarios de Salud/tendencias , Estudios Transversales , Escolaridad , Femenino , Encuestas Epidemiológicas , Humanos , Renta , Mozambique , Pobreza , Adulto JovenRESUMEN
OBJECTIVE: Assessing the level of adherence and its determinants is important in appraising the overall effectiveness of trials. The present study aimed to evaluate the extent of adherence and its determinants in a pragmatic randomized controlled trial of Fe prophylaxis during pregnancy in Maputo, Mozambique. DESIGN: A pragmatic randomized controlled trial. SETTING: Two health centres (1° de Maio and Machava) in Maputo, Mozambique. SUBJECTS: Pregnant women (≥12 weeks' gestation, ≥18 years old, non-high-risk pregnancy; n 4326) attending prenatal care consultations at two health centres were randomized to receive routine Fe (n 2184; 60 mg ferrous sulfate plus 400 µg folic acid daily throughout pregnancy) or selective Fe (n 2142; screening and treatment for anaemia and daily intake of 1 mg folic acid). RESULTS: The level of adherence was 79% for having two or more visits, 53% for adequate prenatal care and 67% for complete intake of Fe/folic acid tablets during the trial. The correlation between the adherence measures ranged between 0·151 and 0·739. Adherence did not differ by trial arm, but there were centre differences in adequate prenatal visits and intake of tablets. Older women (>20 years) and those with a history of abortion were more likely to achieve greater adherence, whereas an increased number of previous births decreased the likelihood of adherence. HIV positivity decreased the likelihood of adherence in one trial centre and increased it in the other. CONCLUSIONS: The variation in adherence by trial centre, women's characteristics and outcome measures suggests that adherence in trials fully depends on participants' behaviour and can be increased by paying attention to contextual factors.
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Anemia Ferropénica/prevención & control , Suplementos Dietéticos , Hematínicos/uso terapéutico , Hierro de la Dieta/uso terapéutico , Cooperación del Paciente , Complicaciones Hematológicas del Embarazo/prevención & control , Fenómenos Fisiologicos de la Nutrición Prenatal , Adolescente , Adulto , Anemia Ferropénica/sangre , Anemia Ferropénica/complicaciones , Anemia Ferropénica/virología , Centros Comunitarios de Salud , Países en Desarrollo , Femenino , Compuestos Ferrosos/administración & dosificación , Ácido Fólico/uso terapéutico , Seropositividad para VIH/complicaciones , Seropositividad para VIH/virología , Humanos , Mozambique , Embarazo , Complicaciones Hematológicas del Embarazo/sangre , Complicaciones Hematológicas del Embarazo/virología , Complicaciones Infecciosas del Embarazo/sangre , Complicaciones Infecciosas del Embarazo/virología , Historia Reproductiva , Adulto JovenRESUMEN
BACKGROUND: The relevance and quantity of clinical research has caused concern and regulation is claimed to hinder clinical research. This paper compares clinical research regulations in Finland to those of England, Canada, and the USA around 2010-2011. METHODS: Several approaches and data sources were used, including semi- or unstructured interviews of experts. For the analysis, a theoretical framework was made, data from various sources was synthesized, and features of the systems were simplified and classified. The various specific names and terms used in the data were changed into general ones. RESULTS: Common structures for the regulation existed in all four countries, but the details and scope varied. The research regulated within the main system was determined by research type (Finland), the financer of the health system (England), or research site (Canada, USA). Only Finland had specific legislation on medical research. The overriding impression of the regulatory systems was one of complexity. All countries had extra regulation for drug research. The types of drug research covered varied from trials with unlicensed (new) products or new indications (USA and Canada), to all types of interventional drug research (England), where 'interventional' was interpreted broadly (Finland). The complexity of regulations had led to the creation of various big and small businesses to help researchers and sponsors. There was notable variation in the role played by the public research funder. The role played by health care was difficult to study and seemed to involve varying interests as researchers were also health care employees. Research ethics committees were important and their tasks also included aspects other than ethics. CONCLUSIONS: This study revealed that a comparison between countries can provide useful insights into the distinctive aspects of each country's system, as well as identifying common features that require international action.
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Personal Administrativo , Investigación Biomédica/legislación & jurisprudencia , Regulación Gubernamental , Canadá , Conflicto de Intereses , Control de Medicamentos y Narcóticos , Inglaterra , Comités de Ética en Investigación , Finlandia , Entrevistas como Asunto , Investigación Cualitativa , Estados UnidosRESUMEN
The effects of prophylactic iron during pregnancy on maternal and child health in developing settings with endemic malaria and high prevalence of HIV remain unclear. This paper describes the rationale, implementation and success of a pragmatic randomised controlled trial comparing routine iron supplementation vs. screening and treatment for anaemia during pregnancy. The setting was two health centres in Maputo, Mozambique. Pregnant women (≥ 12-week gestation; ≥ 18 years old; and not with a high-risk pregnancy, n=4326) were recruited. The main outcomes are preterm delivery and low birthweight. The women were randomly assigned to one of two iron administration policies: a routine iron group (n=2184) received 60 mg of ferrous sulphate plus 400 µg of folic acid daily while a selective iron group (n=2142) had screening and treatment for anaemia and a daily intake of 1 mg of folic acid. The recruitment, follow-up, and collection of follow-up data were successful; both groups were similar to each other in all the trial stages. Collection of delivery data was challenging and data on about 40% of births is missing. These are currently being traced through different hospitals and health centres. The compliance of the study personnel and the women with regard to regular measurement of haemoglobin and intake of the iron and folic acid tablets was high and similar in both trial arms. Taking into account the various constraints encountered, the stages of the present trial prior to delivery were carried out well.
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Anemia Ferropénica/prevención & control , Infecciones por VIH/epidemiología , Hierro/sangre , Malaria/epidemiología , Complicaciones del Embarazo/prevención & control , Adulto , Anemia Ferropénica/sangre , Suplementos Dietéticos , Estudios de Factibilidad , Femenino , Ácido Fólico/administración & dosificación , Estudios de Seguimiento , Edad Gestacional , Hemoglobinas/metabolismo , Humanos , Recién Nacido de Bajo Peso/sangre , Hierro/administración & dosificación , Mozambique , Cooperación del Paciente , Proyectos Piloto , Embarazo , Complicaciones del Embarazo/sangre , Resultado del Embarazo , Prevalencia , Resultado del Tratamiento , Adulto JovenRESUMEN
Key findings and recommendations from a study comparing clinical research regulation in Finland with those in England, Canada (Ontario) and USA are presented. Data were collected with various methods, including interviewing key experts. While the norms and ethical codes were similar, the interpretation partly differed. In each country there were various actors in regulation and practical arrangements differed. Research ethics committees (REC) were crucial, as well as drug authorities in research with drugs. Recommendations include reforming the medical research law, widening the dimensions of ethics judgment, restricting the REC tasks, including a central committee, and introducing quality assurance and restricting the drug control authority tasks.
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Investigación Biomédica/ética , Investigación Biomédica/legislación & jurisprudencia , Comités de Ética en Investigación/legislación & jurisprudencia , Ética en Investigación , Códigos de Ética , Inglaterra , Revisión Ética , Finlandia , Regulación Gubernamental , Humanos , Entrevistas como Asunto , Ontario , Estados UnidosRESUMEN
HIV testing constitutes an important strategy to control the HIV epidemic, which therefore merits an observation of HIV testing practices to help improve testing effectiveness. In 2008, a cross-sectional survey among recently diagnosed (≤ 3 years) HIV-infected patients was conducted in Belgium, Estonia, Finland and Portugal. Participants were questioned about reasons for HIV testing, testing place and testing conditions. Univariate and multivariate analyses were performed. Out of 1460 eligible participants, 629 (43%) were included. Forty-one per cent were diagnosed late and 55% had never undergone a previous HIV test with perceived low risk being the primary reason for not having been tested earlier. Heterogeneity in HIV testing practices was observed across countries. Overall, tests were most frequently conducted in primary care (38%) and specialised clinics (21%), primarily on the initiative of the health care provider (65%). Sixty-one per cent were tested with informed consent, 31% received pretest counselling, 78% received post-test counselling, 71% were involved in partner notification and 92% were in care three months after diagnosis. The results showed that HIV testing is done in a variety of settings suggesting that multiple pathways to HIV testing are provided. HIV testing practice is being normalised, with less focus on pretest counselling, yet with emphasis on post-test follow-up. Major barriers to testing are centred on the denial of risk. Efforts are needed to concurrently promote public awareness about HIV risk and benefits of HIV testing and train clinicians to be more proactive in offering HIV testing.
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Serodiagnóstico del SIDA , Diagnóstico Tardío , Infecciones por VIH/diagnóstico , Tamizaje Masivo/métodos , Adolescente , Adulto , Anciano , Actitud Frente a la Salud , Consejo , Estudios Transversales , Europa (Continente)/epidemiología , Femenino , Infecciones por VIH/epidemiología , Accesibilidad a los Servicios de Salud , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Atención Primaria de Salud/organización & administración , Adulto JovenRESUMEN
INTRODUCTION: Social determinants of health have not been intensively studied in Russia, even though the health divide has been clearly demonstrated by an increased mortality rate among those with low education. A comparative analysis of social health determinants in countries with different historical and economic backgrounds may provide useful evidence for addressing health inequalities. We aimed to assess socioeconomic determinants of self-rated health in St. Petersburg as compared to Estonia and Finland. METHODS: Data for women aged 18-44 were extracted from existing population-based surveys and analysed. In St. Petersburg the data were originally collected in 2003 (response rate 68%), in Estonia in 2004-2005 (54%), and in Finland in 2000-2001 (86%). The study samples comprised 865 women in St. Petersburg, 2141 in Estonia and 1897 in Finland. RESULTS: Self-rated health was much poorer in St. Petersburg than in Estonia or Finland. High education was negatively associated with poor self-rated health in all the studied populations; it was (partially) mediated via health behaviour and limiting long-term illness only in Estonia and Finland, but not in St. Petersburg. High personal income and employment did not associate with poor self-rated health among St. Petersburg women, as it did in Estonia and Finland. In St. Petersburg housewives rather than employed women had better self-rated health, unlike the two other areas. CONCLUSION: Women's self-rated health in St. Petersburg varied similarly by education but differently by income and employment as compared to Estonia and Finland. Education is likely the most meaningful dimension of women's socioeconomic position in St. Petersburg. More research is needed to further clarify the pathways between socioeconomic position and health in Russia.
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Escolaridad , Empleo , Disparidades en el Estado de Salud , Renta , Salud de la Mujer , Adolescente , Adulto , Estonia , Femenino , Finlandia , Encuestas Epidemiológicas , Humanos , Pobreza , Federación de Rusia , Autoinforme , Salud de la Mujer/economía , Adulto JovenRESUMEN
BACKGROUND: Cesarean section (CS) rate has increased rapidly over the past two decades in China mainly driven by non-medical factors. This study was to compare recalled preferences for CS among first-time mothers in early and late pregnancy with actual delivery mode; to explore factors related to CS preference and CS performed without medical indications; and to consider the role of healthcare providers in delivery mode preferences. METHODS: An anonymous questionnaire survey, combined with data on CS indications taken from the patient record, was conducted among 272 first-time mothers having their first postnatal check-up in one university affiliated obstetrics and gynecology hospital in Shanghai, China, between September 2006 and January 2007. Logistic regression was used to study factors related to the recalled preference for CS and CS performed without medical indication, adjusting for maternal age, education and income. RESULTS: The CS rate was 57% (151/263) among all women, 17% with medical indications and 40% without medical indications. For women without medical indications for CS (n = 215), there was no significant difference between women's preference for CS in early (25%) and late pregnancy (28%); 48% of women actually had CS. Women recalled preferring a vaginal delivery but who had CS were more likely to have had a CS suggested by a prenatal care doctor [OR (95% CI): 20 (3.88-107.1)] or by a delivery obstetrician [OR (95% CI): 26 (6.26-105.8)]. Among women recalled preferring and having CS, a suggestion from the prenatal care doctor to have CS was very common. CONCLUSIONS: In the primiparous women without a medical indication for CS, women recall of a provider suggestion for CS was a strong predictor of CS both among women who recalled a preference for CS and among women who recalled a preference for vaginal delivery. Public health education needs strengthening, including discussion of the risks associated with CS and psychological and social support given to women to help them prepare for and cope with childbirth.
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Cesárea/psicología , Cesárea/estadística & datos numéricos , Consejo Dirigido , Procedimientos Quirúrgicos Electivos/estadística & datos numéricos , Prioridad del Paciente/estadística & datos numéricos , Pautas de la Práctica en Medicina , Adulto , China , Conducta de Elección , Femenino , Humanos , Paridad , Embarazo , Trimestres del Embarazo , Estudios Retrospectivos , Factores de Tiempo , Adulto JovenRESUMEN
OBJECTIVE: To obtain information about the similarities and differences in regulating different types of medical research in the European Union (EU). METHODS: Web searches were performed from September 2009 to January 2011. Notes on pre-determined topics were systematically taken down from the web pages. The analysis relied only on documents and reports available on the web, reflecting the situation at the end of 2010. RESULTS: In several countries, regulatory legislation applied only to clinical trials on drugs and medical devices, in other states various types of research were also regulated but by laws different from those concerning trials, and in many countries, some research areas were not controlled by legislation at all. In very few countries was all medical research handled similarly from a legal point of view. The number of research ethics committees (RECs) in a single country varied from one to 264. Their areas of responsibility, working principles and length of time to grant research permission varied as well as the rules for obtaining informed consent from vulnerable groups. In 10 EU countries, there was no appeal mechanism after a negative decision by an REC. The RECs were not accountable to any organisation in five EU countries. CONCLUSIONS: There is a need for a fundamental debate regarding whether and which kinds of changes are needed for the further harmonisation of medical research governance in the EU and how cross-country medical research could be facilitated in the future.
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Investigación Biomédica/ética , Investigación Biomédica/legislación & jurisprudencia , Comités de Ética en Investigación/organización & administración , Unión Europea/organización & administración , Comités de Ética en Investigación/ética , Humanos , Cooperación Internacional , Poblaciones VulnerablesRESUMEN
BACKGROUND: Schools provide a natural context to promote children's mental health. However, there is a need for more evidence-based, high quality school intervention programs combined with an accurate evaluation of their general effectiveness and effectiveness of specific intervention methods. The aim of this paper is to present a study protocol of a cluster randomized controlled trial evaluating the "Together at School" intervention program. The intervention program is designed to promote social-emotional skills and mental health by utilizing whole-school approach and focuses on classroom curriculum, work environment of school staff, and parent-teacher collaboration methods. METHODS/DESIGN: The evaluation study examines the effects of the intervention on children's socio-emotional skills and mental health in a cluster randomized controlled trial design with 1) an intervention group and 2) an active control group. Altogether 79 primary school participated at baseline. A multi-informant setting involves the children themselves, their parents, and teachers. The primary outcomes are measured using parent and teacher ratings of children's socio-emotional skills and psychological problems measured by the Strengths and Difficulties Questionnaire and the Multisource Assessment of Social Competence Scale. Secondary outcomes for the children include emotional understanding, altruistic behavior, and executive functions (e.g. working memory, planning, and inhibition). Secondary outcomes for the teachers include ratings of e.g. school environment, teaching style and well-being. Secondary outcomes for both teachers and parents include e.g. emotional self-efficacy, child rearing practices, and teacher-parent collaboration. The data was collected at baseline (autumn 2013), 6 months after baseline, and will be collected also 18 months after baseline from the same participants. DISCUSSION: This study protocol outlines a trial which aims to add to the current state of intervention programs by presenting and studying a contextually developed and carefully tested intervention program which is tailored to fit a national school system. Identification of effective intervention elements to promote children's mental health in early school years is crucial for optimal later development. TRIAL REGISTRATION: ClinicalTrials.gov register: NCT02178332.
Asunto(s)
Desarrollo Infantil , Emociones , Salud Mental , Servicios de Salud Escolar , Habilidades Sociales , Niño , Conducta Cooperativa , Docentes , Femenino , Finlandia , Humanos , Masculino , Padres , Evaluación de Programas y Proyectos de Salud , Encuestas y CuestionariosRESUMEN
OBJECTIVES: To describe the pattern and determinants of working during pregnancy in rural China. METHODS: A cross-sectional survey was carried out in 2009 in three provinces (Anhui, Chongqing and Shaanxi) in rural China among 3966 mothers who had recently given birth. Multilevel logistic regression was used to examine the determinants of work behaviour during pregnancy. RESULTS: Overall, 39% of the women stopped working during early pregnancy, 32% worked the same throughout pregnancy and the rest decreased their work or stopped later in pregnancy. Women from Anhui (53%) and Chongqing (54%) provinces were more likely to stop work in early pregnancy than women from Shaanxi province (20%). Older women [odds ratio (OR) 0.74, 95% confidence interval (CI) 0.56-0.99], those having two or more children (OR 0.55, 95% CI 0.43-0.69) and non-farmers (OR 0.50, 95% CI 0.65-0.99) were less likely to stop working on the first trimester, but those with higher education (high school OR 1.43, 95% CI 1.05-1.94) were more likely to stop working. Stopping work early was not related to household income and adequacy of prenatal care. Women with two or more children, non-farmers and those from Shaanxi province were more likely to continue to work to the same extent during pregnancy. But those with higher household income and middle and high school were less likely to work the same. CONCLUSIONS: Women's working patterns during pregnancy in rural China were polarized: many women stopped working already in early pregnancy, but others continued to work as before. The key determinant of the working patterns was the province of residence.
Asunto(s)
Empleo/estadística & datos numéricos , Embarazo/estadística & datos numéricos , Población Rural/estadística & datos numéricos , Adulto , China/epidemiología , Estudios Transversales , Escolaridad , Femenino , Humanos , Renta/estadística & datos numéricos , Modelos Logísticos , Edad Materna , Paridad , Embarazo/psicología , Adulto JovenRESUMEN
BACKGROUND: To present empirical data on how the variation in regulating clinical research and patient care was perceived in Finland between 2009 and 2012. METHODS: Notes of interviews with 22 research ethics committee (REC) chairpersons were analyzed to identify whether differences in the regulation of clinical research and patient care were addressed. REC chairpersons' opinions on three imaginary cases of clinical research projects challenging current research ethics rules (vignettes) were requested with a questionnaire; 18 of the 22 interviewed chairpersons responded. RESULTS: Based on REC chairpersons' interviews, the differences between care and research regulation were not considered important issues in Finland. In the vignettes, REC chairpersons' assumptions on how their REC would decide varied in regard to allowing research without informed consent, while solutions that are not allowed by current law were even anticipated. Mostly, but not always, the chairpersons' own personal view agreed with their REC. CONCLUSIONS: The distinction between care and research regulation has not been publicly challenged by Finnish RECs, even though it is a challenge when research relevant to health care is carried out. There is a need for debate and changes in laws and practices.
Asunto(s)
Actitud del Personal de Salud , Investigación Biomédica/ética , Comités de Ética en Investigación , Atención al Paciente/ética , Investigación Biomédica/legislación & jurisprudencia , Análisis por Conglomerados , Ética en Investigación , Femenino , Finlandia , Humanos , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto/ética , Ensayos Clínicos Controlados Aleatorios como Asunto/legislación & jurisprudenciaRESUMEN
BACKGROUND AND METHODS: Treatment practices of pregnancies and deliveries and newborn health have differed from each other between Finland and Estonia. We examined changes in the differences from 1997 to 2011 from national birth registers and official statistics. RESULTS: Deliveries, abortions and overall fertility remained similar in Finland. In Estonia, the number of deliveries increased and abortions decreased. Problems in the perinatal period continued to be more common in Estonia. CONCLUSIONS: Estonian reproductive health and treatment practices of deliveries have approached the situation in Finland.