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1.
J Med Ethics ; 50(4): 226-233, 2024 Mar 20.
Artigo em Inglês | MEDLINE | ID: mdl-37722810

RESUMO

The classification of medical interventions as either invasive or non-invasive is commonly regarded to be morally important. On the most commonly endorsed account of invasiveness, a medical intervention is invasive if and only if it involves either breaking the skin ('incision') or inserting an object into the body ('insertion'). Building on recent discussions of the concept of invasiveness, we show that this standard account fails to capture three aspects of existing usage of the concept of invasiveness in relation to medical interventions-namely, (1) usage implying that invasiveness comes in degrees, (2) that the invasiveness of an intervention can depend on the characteristics of the salient alternative interventions, and (3) that medical interventions can be invasive in non-physical ways. We then offer the beginnings of a revised account that, we argue, is able to capture a wider range of existing usage. Central to our account is a distinction between two properties: basic invasiveness and threshold invasiveness We end by assessing what the standard account gets right, and what more needs to be done to complete our schematic account.

2.
J Med Ethics ; 2024 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-38408854

RESUMO

The possibility of neurotechnological interference with our brain and mind raises questions about the moral rights that would protect against the (mis)use of these technologies. One such moral right that has received recent attention is the right to mental integrity. Though the metaphysical boundaries of the mind are a matter of live debate, most defences of this moral right seem to assume an internalist (brain-based) view of the mind. In this article, we will examine what an extended account of the mind might imply for the right to mental integrity and the protection it provides against neurotechnologies. We argue that, on an extended account of the mind, the scope of the right to mental integrity would expand significantly, implying that neurotechnologies would no longer pose a uniquely serious threat to the right. In addition, some neurotechnologies may even be protected by the right to mental integrity, as the technologies would become part of the mind. We conclude that adopting an extended account of the mind has significant implications for the right to mental integrity in terms of its protective scope and capacity to protect against neurotechnologies, demonstrating that metaphysical assumptions about the mind play an important role in determining the moral protection provided by the right.

3.
Eur Radiol ; 33(8): 5258-5268, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37042982

RESUMO

INTRODUCTION: Radiographs of the hand and teeth are frequently used for medical age assessment, as skeletal and dental maturation correlates with chronological age. These methods have been criticized for their lack of precision, and magnetic resonance imaging (MRI) of the knee has been proposed as a more accurate method. The aim of this systematic review is to explore the scientific and statistical evidence for medical age estimation based on skeletal maturation as assessed by MRI of the knee. MATERIALS AND METHODS: A systematic review was conducted that included studies published before April 2021 on living individuals between 8 and 30 years old, with presumptively healthy knees for whom the ossification stages had been evaluated using MRI. The correlation between "mature knee" and chronological age and the risk of misclassifying a child as an adult and vice versa was calculated. RESULTS: We found a considerable heterogeneity in the published studies -in terms of study population, MRI protocols, and grading systems used. There is a wide variation in the correlation between maturation stage and chronological age. CONCLUSION: Data from published literature is deemed too heterogenous to support the use of MRI of the knee for chronological age determination. Further, it is not possible to assess the sensitivity, specificity, negative predictive value, or positive predictive value for the ability of MRI to determine whether a person is over or under 18 years old. KEY POINTS: • There is an insufficient scientific basis for the use of magnetic resonance imaging of the knee in age determination by skeleton. • It is not possible to assess the predictive value of MRI of the knee to determine whether a person is over or under 18 years of age.


Assuntos
Determinação da Idade pelo Esqueleto , Articulação do Joelho , Adolescente , Adulto , Criança , Humanos , Adulto Jovem , Determinação da Idade pelo Esqueleto/métodos , Joelho/diagnóstico por imagem , Articulação do Joelho/diagnóstico por imagem , Imageamento por Ressonância Magnética/métodos , Radiografia
4.
Acta Paediatr ; 111(10): 1891-1898, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-35673836

RESUMO

AIM: Previous studies on breastfeeding during lithium therapy have shown conflicting results. The aim of this study was to evaluate the safety when practising thorough follow-up of the infants. METHOD: This retrospective study focused on women with lithium medication, and their breastfed infants born between 2006 and 2021 in Stockholm, Sweden. Information about infant serum lithium concentrations and clinical status was collected from medical records. RESULTS: In total, 30 infants exposed to lithium through breastmilk, 21 girls and 9 boys, were included. The median age at follow-up was 40 days (range 8-364 days). The median lithium serum concentration was 0.10 mmol/L in the second week of life (range <0.05-0.7 mmol/L), 0.08 in week 2-4 (range <0.05-1.2), 0.06 in the second month of life (range <0.05-0.2) and 0.07 after 2 months of age (range <0.05-0.2). Unexpectedly high lithium concentrations were found in two infants in the first month of life. Apart from poor weight gain, no adverse effects were found. CONCLUSION: Serum lithium concentrations in breastfed infants were stabilised at barely measurable levels after the first weeks of life. Before that, concentrations higher than the mothers were found. Lithium treatment during breastfeeding can be considered safe under strict follow-up.


Assuntos
Aleitamento Materno , Lítio , Feminino , Humanos , Lactente , Lítio/efeitos adversos , Masculino , Leite Humano , Estudos Retrospectivos , Aumento de Peso
5.
J Med Ethics ; 2020 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-32820018

RESUMO

Would compulsory treatment or vaccination for COVID-19 be justified? In England, there would be significant legal barriers to it. However, we offer a conditional ethical argument in favour of allowing compulsory treatment and vaccination, drawing on an ethical comparison with external constraints-such as quarantine, isolation and 'lockdown'-that have already been authorised to control the pandemic in this jurisdiction. We argue that, if the permissive English approach to external constraints for COVID-19 has been justified, then there is a case for a similarly permissive approach to compulsory medical interventions.

7.
J Med Ethics ; 40(1): 63-8, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-24126202

RESUMO

We explore the ethics of using motivational interviewing (MI), an evidence-based, client-centred and directional counselling method, in conversations with next of kin about deceased solid organ donation. After briefly introducing MI and providing some context around organ transplantation and next of kin consent, we describe how MI might be implemented in this setting, with the hypothesis that MI has the potential to bring about a modest yet significant increase in next of kin consent rates. We subsequently consider the objection that using MI in this context would be manipulative. Although we cannot guarantee that MI would never be used in a problematically manipulative fashion, we conclude that its use would, nevertheless, be permissible as a potential means to increase next of kin consent to deceased solid organ donation. We propose that MI be trialled in consent situations with next of kin in nations where there is widespread public support for organ donation.


Assuntos
Tomada de Decisões/ética , Família/psicologia , Entrevista Motivacional/ética , Obtenção de Tecidos e Órgãos/ética , Comunicação , Morte , Humanos , Consentimento Livre e Esclarecido , Princípios Morais , Autonomia Pessoal
8.
Int J Bipolar Disord ; 11(1): 36, 2023 Nov 30.
Artigo em Inglês | MEDLINE | ID: mdl-38032417

RESUMO

BACKGROUND: Neonatal effects of late intrauterine and early postpartum exposure to lithium through mother's own milk are scarcely studied. It is unclear whether described symptoms in breastfed neonates are caused by placental lithium transfer or postnatal exposure to lithium through breastfeeding. We aimed to investigate lithium clearance and neonatal morbidity in breastfed infants with high versus low serum lithium concentrations at birth. METHODS: This retrospective study focused on breastfed infants to women treated with lithium during and after pregnancy, born between 2006 and 2021 in Stockholm, Sweden. Information on serum lithium concentrations and adverse neonatal outcomes was obtained from medical records. Neonatal symptoms and lithium clearance were compared between a high exposure group (HEG, lithium concentrations ≥ 0.6 meq/l) and a low exposure group (LEG, < 0.6 meq/l). RESULTS: A total of 25 infant-mother dyads were included. Median lithium serum concentration at birth was 0.90 meq/l in the HEG as compared with 0.40 meq/l in the LEG (p < 0.05). The difference was still significant at follow-up (0.20 meq/l vs 0.06 meq/l, p < 0.05), despite reduction in maternal dose. The rate of neonatal symptoms was 85.7% in HEG and 41.2% in LEG (p = 0.08) at birth and 28.6% vs 11.8% at follow-up (p = 0.55). Furthermore, 28.6% of infants in HEG were admitted to neonatal care, vs 5.9% in LEG (p = 0.19). Two infants in the HEG had therapeutic lithium levels at follow-up. All infants with symptoms at follow-up were either in the HEG or exposed to additional psychotropic medication. CONCLUSIONS: Neonatal symptoms are common after late intrauterine lithium exposure, however transient, treatable and mostly mild. In this study, a high lithium concentration at birth was a risk factor for an increased lithium level at follow-up. Polypharmacy may constitute an additional risk factor. This study suggests that the late intrauterine exposure to lithium might add to the adverse effects in lithium-exposed, breastfed infants. Consequently we recommend breastfed infants with therapeutic lithium concentrations at birth to be followed up promptly to avoid lithium toxicity.

9.
Crim Law Philos ; 16(1): 103-126, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35530429

RESUMO

It is often said that the institutions of criminal justice ought or-perhaps more often-ought not to rehabilitate criminal offenders. But the term 'criminal rehabilitation' is often used without being explicitly defined, and in ways that are consistent with widely divergent conceptions. In this paper, we present a taxonomy that distinguishes, and explains the relationships between, different conceptions of criminal rehabilitation. Our taxonomy distinguishes conceptions of criminal rehabilitation on the basis of (i) the aims or ends of the putatively rehabilitative measure, and (ii) the means that may be used to achieve the intended end. We also explore some of the implications of each conception, some of the payoffs of a taxonomy of the kind we offer, and some areas for future work.

10.
BMJ Open ; 12(6): e061328, 2022 06 29.
Artigo em Inglês | MEDLINE | ID: mdl-35768086

RESUMO

OBJECTIVE: To investigate the admission rate to neonatal care and neonatal morbidity after maternal use of antipsychotics during pregnancy. DESIGN: A population-based register study. SETTING: Information on all singleton births between July 2006 and December 2017 in Sweden including data on prescription drugs, deliveries and infants' health was obtained from the Swedish Medical Birth Register, the Prescribed Drug Register and the Swedish Neonatal Quality Register. Exposed infants were compared with unexposed infants and with infants to mothers treated with antipsychotics before or after but not during pregnancy. PARTICIPANTS: The cohort comprised a total of 1 307 487 infants, of whom 2677 (0.2%) were exposed to antipsychotics during pregnancy and 34 492 (2.6%) had mothers who were treated before/after the pregnancy. OUTCOME MEASURES: The primary outcome was admission rate to neonatal care. Secondary outcomes were the separate neonatal morbidities. RESULTS: Of the exposed infants, 516 (19.3%) were admitted to neonatal care compared with 98 976 (7.8%) of the unexposed infants (adjusted risk ratio (aRR): 1.7; 95% CI: 1.6 to 1.8), with a further increased risk after exposure in late pregnancy. The highest relative risks were seen for withdrawal symptoms (aRR: 17.7; 95% CI: 9.6 to 32.6), neurological disorders (aRR: 3.4; 95% CI: 2.4 to 5.7) and persistent pulmonary hypertension (aRR: 2.1; 95% CI: 1.4 to 3.1) when compared with unexposed infants. The absolute risks for these outcomes were however low among the exposed infants, 1.3%, 1.8% and 1.0%, respectively, and the relative risks were lower when compared with infants to mothers treated before/after the pregnancy. CONCLUSION: Fetal exposure to antipsychotics was associated with an increased risk of neonatal morbidity. The effects in the exposed infants seem transient and predominantly mild, and these findings do not warrant discontinuation of a necessary treatment but rather increased monitoring of these infants. The increased risk of persistent pulmonary hypertension requires further studies.


Assuntos
Antipsicóticos , Hipertensão Pulmonar , Antipsicóticos/efeitos adversos , Estudos de Coortes , Feminino , Humanos , Lactente , Recém-Nascido , Morbidade , Parto , Gravidez
11.
CNS Drugs ; 36(5): 529-539, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35220525

RESUMO

OBJECTIVE: We aimed to study whether antipsychotic use during pregnancy is associated with gestational diabetes. METHODS: This was a Swedish national register-based cohort study on the Medical Birth Register and the Prescribed Drug Register including all 1,307,487 singleton births between July 2006 and December 2017. Antipsychotics were divided into first-generation antipsychotics (n = 728), high-risk metabolic second-generation antipsychotics including olanzapine, clozapine and quetiapine (n = 1710), and other second-generation antipsychotics (n = 541). The risks for gestational diabetes, foetal growth disturbances, pre-eclampsia, caesarean section and preterm labour were assessed. Women treated during pregnancy were compared to women not treated during pregnancy and to women who used antipsychotics before/after but not during pregnancy. RESULTS: The crude risk ratio for gestational diabetes for women treated with high-risk metabolic second-generation antipsychotics during pregnancy was 2.2 (95% confidence interval [CI] 1.6-2.9) compared to untreated pregnant women (n = 1,296,539) and 1.8 (95% CI 1.4-2.5) compared to women treated before/after pregnancy (n = 34,492). After adjustment for maternal factors including body mass index, the risk ratios were 1.8 (95% CI 1.3-2.4) and 1.6 (95% CI 1.2-2.1). Exposed infants had an increased risk of being large for gestational age: adjusted risk ratios 1.6 (95% CI 1.3-1.9) and 1.3 (95% CI 1.1-1.6) compared to no maternal antipsychotic use during pregnancy and maternal use before/after the pregnancy. Other antipsychotics were not associated with metabolic risks. CONCLUSIONS: Olanzapine, clozapine and quetiapine used during pregnancy were associated with increased risks for gestational diabetes and the infant being large for gestational age. Enhanced metabolic monitoring should be considered for pregnant women using these drugs.


The use of second-generation antipsychotics amongst pregnant women is increasing. The side effects of these drugs, for example weight gain and increased blood sugar, are well described for the general population. In particular, olanzapine, quetiapine and clozapine are known to cause these effects. Studies on their effects on blood sugar control in pregnant women have however been conflicting. Pregnancy itself also imposes a risk for increased blood sugar levels and gestational diabetes. The purpose of this study was to evaluate the risk of gestational diabetes connected to the use of antipsychotics during pregnancy. The study was nationwide and register based including 1.3 million births in Sweden between July 2006 and December 2017. The rates of gestational diabetes and the infants being small for gestational age or large for gestational age amongst women treated with antipsychotics were compared to the rates in pregnant women who did not receive antipsychotics and to rates in a control group of women treated with antipsychotics before/after but not during pregnancy. Antipsychotics were divided into three groups: (i) first-generation antipsychotics, (ii) high-risk second-generation antipsychotics including olanzapine, quetiapine and clozapine, and (iii) other second-generation antipsychotics. Women treated with high-risk second-generation antipsychotics were found to have an increased risk of gestational diabetes and giving birth to an infant being large for gestational age, both when compared with untreated pregnant women and with the control group. Other antipsychotics were not connected to increased risks of these outcomes. Hence, pregnant women treated with olanzapine, quetiapine or clozapine should be monitored regarding blood sugar levels.


Assuntos
Antipsicóticos , Clozapina , Diabetes Gestacional , Antipsicóticos/efeitos adversos , Cesárea , Clozapina/uso terapêutico , Estudos de Coortes , Diabetes Gestacional/induzido quimicamente , Diabetes Gestacional/tratamento farmacológico , Diabetes Gestacional/epidemiologia , Feminino , Humanos , Recém-Nascido , Olanzapina , Gravidez , Fumarato de Quetiapina , Suécia/epidemiologia
12.
Med Sci Law ; 62(4): 275-282, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-35274997

RESUMO

There is currently no specific guidance addressing vaccine hesitancy in those with mental health difficulties in the United Kingdom. This is particularly problematic when one considers that individuals with serious mental illnesses are at greater risk of infection and have poorer health outcomes for a range of reasons. There are also many individual and system level barriers to vaccination in this group. When an affected adult lacks the capacity to make a decision for themselves, it often falls to healthcare professionals to make a decision on that person's behalf and in their best interests. This article explores this matter with regard to the law in practice in the English and Welsh, and Scottish, jurisdictions and consider this with relevance to the safest approach that doctors and other healthcare professionals should take in working with patients for whom mental disorder may impact on decision-making capacity. The article focuses on psychiatric inpatients, including those who are detained involuntarily, to consider whether, and in what circumstances, COVID-19 vaccination should be given to individuals who cannot or do not consent.


Assuntos
COVID-19 , Competência Mental , Adulto , Vacinas contra COVID-19 , Tomada de Decisões , Inglaterra , Humanos , Saúde Mental , Vacinação , País de Gales
13.
Epilepsia ; 52(2): 364-9, 2011 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-21054354

RESUMO

PURPOSE: In order to evaluate long-term effects on neurodevelopment in children born to women with epilepsy during pregnancy we studied the children's school grades at age 16. METHODS: We used the Patient Register, the Medical Birth Register, and a local study at South Hospital, Stockholm, to identify women with epilepsy in Sweden who had given birth between 1973 and 1986. The Swedish School Mark Registry was used to obtain information about school grades from the last year of compulsory school, at age 16. Exposed children were compared to all other children born in Sweden between 1973 and 1986. KEY FINDINGS: Medical records were analyzed for 1,235 children. Six hundred forty-one children had been exposed in utero to antiepileptic drugs (AEDs) in monotherapy, 429 in polytherapy, and 165 to no known AED. Children exposed to polytherapy had an increased risk of not receiving a final grade--odds ratio (OR) 2.99 [95% confidence interval (CI) 2.14-4.17]. Children exposed to monotherapy, mainly carbamazepine or phenytoin, did not have a significantly increased risk of not receiving a final grade-OR 1.19 (95% CI 0.79-1.80). Children born to women with epilepsy had a decreased chance of getting a "pass with excellence." SIGNIFICANCE: Exposure to several AEDs in utero may have negative effects on neurodevelopment, and polytherapy should, if possible, be avoided in pregnant women.


Assuntos
Anticonvulsivantes/efeitos adversos , Efeitos Tardios da Exposição Pré-Natal/psicologia , Instituições Acadêmicas , Logro , Adolescente , Desempenho Atlético , Cognição/efeitos dos fármacos , Quimioterapia Combinada/efeitos adversos , Feminino , Seguimentos , Humanos , Idioma , Estudos Longitudinais , Masculino , Matemática , Razão de Chances , Polimedicação , População , Gravidez , Suécia/epidemiologia
14.
Eur J Clin Pharmacol ; 67(7): 715-22, 2011 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-21246351

RESUMO

PURPOSE: The purpose of this study was to determine the 4ß-hydroxycholesterol to cholesterol ratio in mothers and neonates at the time of birth and 4 months post-partum. METHOD: 21 mothers and 22 neonates were recruited at the delivery ward at Karolinska University Hospital, Huddinge, Sweden. Blood samples taken from mothers and neonates at birth and 4 months post-partum were analysed for 4ß-hydroxycholesterol and cholesterol. RESULTS: The median plasma concentration of 4ß-hydroxycholesterol was higher in mothers at delivery (50 ng/mL) compared to healthy non-pregnant women (29 ng/mL). The pregnant women had a higher median cholesterol concentration (6.2 mmol/L) compared to healthy non-pregnant women (4.6 mmol/L) but this could only partly explain the increased 4ß-hydroxycholesterol. The major cause is an increased CYP3A activity during pregnancy. The median 4ß-hydroxycholesterol/cholesterol ratio·10(4) was elevated in mothers at time of birth compared to non-pregnant women (0.19 and 0.15, respectively) but decreased to 0.15 4 months post-partum. Neonates had a median 4ß-hydroxycholesterol/cholesterol ratio·10(4) (0.19) comparable to adults already at birth, but lower 4ß-hydroxycholesterol (12 ng/mL) and cholesterol (1.8 mmol/L) concentrations. CONCLUSION: Pregnancy leads to increased CYP3A enzyme activity as determined by the 4ß-hydroxycholesterol/cholesterol ratio. Neonates have low 4ß-hydroxycholesterol and cholesterol concentrations but similar total CYP3A activity as adults already at birth.


Assuntos
Biomarcadores/sangue , Citocromo P-450 CYP3A/metabolismo , Hidroxicolesteróis/sangue , Recém-Nascido/sangue , Gravidez/sangue , Adulto , Colesterol/sangue , Citocromo P-450 CYP3A/genética , Feminino , Seguimentos , Humanos , Lactente , Masculino , Polimorfismo de Nucleotídeo Único , Fatores de Tempo
15.
Med Law Rev ; 24(4): 453-473, 2016 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-28158492
16.
Can J Philos ; 50(3): 322-338, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33897061

RESUMO

We engage with the nature and the value of achievement through a critical examination of an argument according to which biomedical "enhancement" of our capacities is impermissible because enhancing ourselves in this way would threaten our achievements. We call this the argument against enhancement from achievement. We assess three versions of it, each admitting to a strong or a weak reading. We argue that strong readings fail, and that weak readings, while in some cases successful in showing that enhancement interferes with the nature or value of achievement, fail to establish that enhancement poses an unusual threat to achievement.

17.
AIDS Care ; 21(2): 189-96, 2009 02.
Artigo em Inglês | MEDLINE | ID: mdl-19229688

RESUMO

HIV/AIDS counselling in South Africa covers a range of areas of prevention and treatment with a commonly used model of lay counsellors trained by non-governmental organisations and working alongside professionals in public health settings. This study presents a single group evaluation of a six-session (12-hour) course of Motivational Interviewing (MI) delivered to 17 HIV/AIDS lay counsellors working in peri-urban settings in Western Cape Province, South Africa. Counsellors reported that they used MI techniques both at the start and at the end of the training. In addition, they reported confidence in their ability to influence their clients' motivation at both time points. The results from the ratings of role play performance showed that there was a marked change in emphasis over the group of counsellors from MI non-adherent practice before training (with advice giving, directiveness, control and confrontation) to more MI adherent practice (asking permission before giving advice, emphasising client autonomy, affirming the client and stressing the client's responsibility to change) at the end of the training. Only a small proportion of the counsellors reached the level of beginning proficiency (according to the Motivational Interviewing Treatment Integrity code) on the measure of the ratio of MI adherent to non-adherent responses. The ratio of reflections to questions and the percentage of open questions also showed improvements in performance across the group but generally to levels below that suggesting beginning proficiency in MI. There was no evidence of any change on global therapist ratings (of empathy and the spirit of MI, i.e. collaboration, evocation and autonomy support) or the percentage of complex reflections across the group of counsellors. Possible explanations for the results and public health implications are discussed.


Assuntos
Aconselhamento/educação , Aconselhamento/normas , Infecções por HIV , Conhecimentos, Atitudes e Prática em Saúde , Síndrome da Imunodeficiência Adquirida , Adulto , Aconselhamento/métodos , Feminino , Humanos , Pessoa de Meia-Idade , Relações Profissional-Paciente , Avaliação de Programas e Projetos de Saúde , África do Sul
20.
BMJ Open ; 8(8): e023281, 2018 08 05.
Artigo em Inglês | MEDLINE | ID: mdl-30082365

RESUMO

INTRODUCTION: Ten per cent of all pregnant women are depressed. Standard therapy of pregnant women with moderate depression is selective serotonin reuptakeinhibitors (SSRI). Observational studies on neurodevelopment after fetal SSRI exposure show conflicting results. Our primary objective is to compare the cognitive development in children exposed to sertraline and maternal depression with those exposed to maternal depression and placebo in utero. We hypothesise that there is a significant neurodevelopmental difference between the groups. As a secondary objective, we study the add-on effect of sertraline to internet-based cognitive behavioural therapy (ICBT) to treat moderate depression during pregnancy. METHODS AND ANALYSIS: MAGDALENA is a randomised, placebo-controlled, double-blinded trial in Stockholm Healthcare Region with 2.3 million inhabitants. The women are recruited in weeks 9-21 of pregnancy either through Antenatal Health Clinics or through social media. They are to be diagnosed with moderate depression without ongoing antidepressive therapy or any serious comorbidity. The women in the intervention arm receive sertraline combined with a 12-week period of ICBT; the control arm is treated with placebo and ICBT. We assess the cognitive development in the offspring at the age of 2 years using Bayley Scales of Infant and Toddler Development, third edition (BSID-III). We aim at recruiting 200 women, 100 women in each treatment arm, to ensure statistical power to detect a clinically relevant difference between the groups. ETHICS AND DISSEMINATION: This randomised trial will provide long-sought evidence about the effects of SSRI and maternal depression during pregnancy on the neurodevelopment in the offspring. The study is approved by the Regional Ethical Review Board at Karolinska Institutet in Stockholm and the Swedish Medical Products Agency. It is registered with the European Clinical Trials Database (EudraCT), Number: 2013-004444-31. Results will be disseminated at scientific conferences, published in peer-reviewed journals and made available to the public. TRIAL REGISTRATION NUMBER: EudraCT2013-004444-31; Pre-results.


Assuntos
Desenvolvimento Infantil/efeitos dos fármacos , Cognição/efeitos dos fármacos , Depressão/complicações , Efeitos Tardios da Exposição Pré-Natal/etiologia , Inibidores Seletivos de Recaptação de Serotonina/farmacologia , Sertralina/farmacologia , Pré-Escolar , Terapia Cognitivo-Comportamental , Depressão/terapia , Método Duplo-Cego , Feminino , Humanos , Lactente , Transtornos do Neurodesenvolvimento/etiologia , Gravidez , Complicações na Gravidez/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Inibidores Seletivos de Recaptação de Serotonina/uso terapêutico , Sertralina/uso terapêutico
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