Objective: To report long-term efficacy and safety results of the SANTE trial investigating deep brain stimulation of the anterior nucleus of the thalamus (ANT) for treatment of localizationrelated epilepsy.Methods: This long-term follow-up is a continuation of a previously reported trial of 5-vs 0-V ANT stimulation. Long-term follow-up began 13 months after device implantation with stimulation parameters adjusted at the investigators' discretion. Seizure frequency was determined using daily seizure diaries.Results: The median percent seizure reduction from baseline at 1 year was 41%, and 69% at 5 years. The responder rate ($50% reduction in seizure frequency) at 1 year was 43%, and 68% at 5 years. In the 5 years of follow-up, 16% of subjects were seizure-free for at least 6 months. There were no reported unanticipated adverse device effects or symptomatic intracranial hemorrhages. The Liverpool Seizure Severity Scale and 31-item Quality of Life in Epilepsy measure showed statistically significant improvement over baseline by 1 year and at 5 years (p , 0.001).Conclusion: Long-term follow-up of ANT deep brain stimulation showed sustained efficacy and safety in a treatment-resistant population. Classification of evidence:This long-term follow-up provides Class IV evidence that for patients with drug-resistant partial epilepsy, anterior thalamic stimulation is associated with a 69% reduction in seizure frequency and a 34% serious device-related adverse event rate at 5 years. Approximately 3 million people in the United States have epilepsy and approximately 30% remain resistant to medical treatment. Some of these patients are candidates for resective surgery.1,2 For those who are not surgical candidates, or who continue to have seizures after surgery, neuromodulation may offer a viable therapeutic option. Several pilot studies, [3][4][5][6] and recent trials including the Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy (SANTE) trial 7 and a trial of responsive cortical stimulation, 8 have demonstrated reduction in seizures. The SANTE trial in 110 subjects with localization-related epilepsy found that seizures were significantly reduced by stimulation. 7 We now report the 5-year efficacy and safety outcomes of this trial.METHODS The SANTE trial 7 utilized a design with a 3-month baseline, 1-month postoperative recovery, followed by 3 months of double-blind treatment randomized to 5 V or 0 V of stimulation, then an open-label conversion of all subjects to 5-V stimulation for 9
Objective The aim of this study was to review systematically the available evidence on studies in humans on the effects of low-moderate levels of prenatal alcohol consumption (up to 10.4 UK units or 83 g/week) compared with consumption of no alcohol on pregnancy outcome.Design Systematic review.Population Pregnant women or women who are trying to become pregnant.Methods The search strategy included Medline, Embase, Cinahl and PsychInfo for the years 1970-2005. Titles and abstracts were read by two researchers and inclusion/exclusion being decided according to prespecified criteria. All the included articles were then obtained and read in full by the two researchers to decide on inclusion. The articles were assessed for quality using the Newcastle-Ottawa Quality Assessment Scales.Main outcome measures Outcomes considered were miscarriage, stillbirth, intrauterine growth restriction, prematurity, birthweight, small for gestational age at birth and birth defects including fetal alcohol syndrome.Results The search resulted in 3630 titles and abstracts, which were narrowed down to 46 relevant articles. At low-moderate levels of consumption, there were no consistently significant effects of alcohol on any of the outcomes considered. Many of the reported studies had methodological weaknesses.Conclusions This systematic review found no convincing evidence of adverse effects of prenatal alcohol exposure at low-moderate levels of exposure. However, weaknesses in the evidence preclude the conclusion that drinking at these levels during pregnancy is safe.Please cite this paper as: Henderson J, Gray R, Brocklehurst P. Systematic review of effects of low-moderate prenatal alcohol exposure on pregnancy outcome.
Despite the highly varied study designs and contexts for the research included, this review provided useful information about women's views of pregnancy ultrasound. One key finding for clinicians was the need for all staff, women, and partners to be well informed about the specific purposes of ultrasound scans and what they can and cannot achieve.
BackgroundEarly involvement of fathers with their children has increased in recent times and this is associated with improved cognitive and socio-emotional development of children. Research in the area of father’s engagement with pregnancy and childbirth has mainly focused on white middle-class men and has been mostly qualitative in design. Thus, the aim of this study was to understand who was engaged during pregnancy and childbirth, in what way, and how paternal engagement may influence a woman’s uptake of services, her perceptions of care, and maternal outcomes.MethodsThis study involved secondary analysis of data on 4616 women collected in a 2010 national maternity survey of England asking about their experiences of maternity care, health and well-being up to three months after childbirth, and their partners’ engagement in pregnancy, labour and postnatally. Data were analysed using descriptive statistics, chi-square, binary logistic regression and generalised linear modelling.ResultsOver 80% of fathers were ‘pleased or ‘overjoyed’ in response to their partner’s pregnancy, over half were present for the pregnancy test, for one or more antenatal checks, and almost all were present for ultrasound examinations and for labour. Three-quarters of fathers took paternity leave and, during the postnatal period, most fathers helped with infant care. Paternal engagement was highest in partners of primiparous white women, those living in less deprived areas, and in those whose pregnancy was planned. Greater paternal engagement was positively associated with first contact with health professionals before 12 weeks gestation, having a dating scan, number of antenatal checks, offer and attendance at antenatal classes, and breastfeeding. Paternity leave was also strongly associated with maternal well-being at three months postpartum.ConclusionsThis study demonstrates the considerable sociodemographic variation in partner support and engagement. It is important that health professionals recognise that women in some sociodemographic groups may be less supported by their partner and more reliant on staff and that this may have implications for how women access care.
Preterm birth is a major predictor of how much an individual will cost hospital service providers during the first 5 years of life.
Objective: The effects of binge-drinking during pregnancy on the fetus and child have been an increasing concern for clinicians and policy-makers. This study reviews the available evidence from human observational studies. Design: Systematic review of observational studies. Population: Pregnant women or women who are trying to become pregnant. Methods: A computerised search strategy was run in Medline, Embase, Cinahl and PsychInfo for the years . Titles and abstracts were read by two researchers for eligibility. Eligible papers were then obtained and read in full by two researchers to decide on inclusion. The papers were assessed for quality using the Newcastle-Ottawa Quality Assessment Scales and data were extracted. Main outcome measures: Adverse outcomes considered in this study included miscarriage; stillbirth; intrauterine growth restriction; prematurity; birth-weight; small for gestational age at birth; and birth defects, including fetal alcohol syndrome and neurodevelopmental effects. Results: The search resulted in 3630 titles and abstracts, which were narrowed down to 14 relevant papers. There were no consistently significant effects of alcohol on any of the outcomes considered. There was a possible effect on neurodevelopment. Many of the reported studies had methodological weaknesses despite being assessed as having reasonable quality. Conclusions: This systematic review found no convincing evidence of adverse effects of prenatal bingedrinking, except possibly on neurodevelopmental outcomes. T he effects of prenatal alcohol consumption on the developing embryo, fetus and child are well known.1 It is generally accepted that heavy drinking is associated with fetal alcohol syndrome (FAS) and fetal alcohol effects such as growth retardation, birth defects and neurodevelopmental problems. 2Animal models have suggested that it is the peak blood alcohol concentration rather than the average intake that determines the level of damage.3 High blood alcohol concentrations are achieved by intake of large volumes of alcohol on a single occasion-that is, binge-drinking. 3Government advice to pregnant women or to women who may become pregnant differs between countries; some, such as Australia and New Zealand, recommend moderation, whereas others, such as the USA, recommend abstinence. The current UK Department of Health guidelines 4 recommend that women who are trying to become pregnant or are at any stage of pregnancy, should not drink more than 1 or 2 units of alcohol once or twice a week, and should avoid episodes of intoxication. However, women's drinking in the general population has increased over the past two decades. For example, the proportion of women in the 16-44-year, fertile age group drinking more than 14 units per week increased from 17% in 1992 to 33% in 2002. The proportion of women in the 16-24-year age group who binge-drink has also increased from 24% in 1998 to 28% in 2002. Binge-drinking is an important topic for women's health, as well as for the fetus and child. For example, binge-drinking is c...
Women having an induction were generally less satisfied with their care, suggesting the need for a focused service for these women to address their additional needs.
BackgroundAccording to the Office for National Statistics, approximately a quarter of women giving birth in England and Wales are from minority ethnic groups. Previous work has indicated that these women have poorer pregnancy outcomes than White women and poorer experience of maternity care, sometimes encountering stereotyping and racism. The aims of this study were to examine service use and perceptions of care in ethnic minority women from different groups compared to White women.MethodsSecondary analysis of data from a survey of women in 2010 was undertaken. The questionnaire asked about women’s experience of care during pregnancy, labour and birth, and the postnatal period, as well as demographic factors. Ethnicity was grouped into eight categories: White, Mixed, Indian, Pakistani, Bangladeshi, Black Caribbean, Black African, and Other ethnicity.ResultsA total of 24,319 women completed the survey. Compared to White women, women from minority ethnic groups were more likely to be younger, multiparous and without a partner. They tended to access antenatal care later in pregnancy, have fewer antenatal checks, fewer ultrasound scans and less screening. They were less likely to receive pain relief in labour and, Black African women in particular, were more likely to deliver by emergency caesarean section. Postnatally, women from minority ethnic groups had longer lengths of hospital stay and were more likely to breastfeed but they had fewer home visits from midwives. Throughout their maternity care, women from minority ethnic groups were less likely to feel spoken to so they could understand, to be treated with kindness, to be sufficiently involved in decisions and to have confidence and trust in the staff.ConclusionWomen in all minority ethnic groups had a poorer experience of maternity services than White women. That this was still the case following publication of a number of national policy documents and local initiatives is a cause for concern.
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