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Transition from antepartum to postpartum care is important, but often fragmented, and attendance at postpartum visits can be poor. Access to care is especially important for individuals diagnosed antepartum with conditions associated with longer-term implications, including gestational diabetes (GDM) and hypertensive disorders in pregnancy (HDP). Strategies to link and strengthen this transition are essential to support people to attend recommended appointments and testing. This narrative review evaluates what is known about postpartum transition of care after higher-risk antepartum conditions, discusses barriers and facilitators to uptake of recommended testing, and outlines strategies trialled to increase both postpartum attendance and testing. Barriers to attendance frequently overlap with general barriers to accessing healthcare. Specific postpartum challenges include difficulties with transport, coordinating breastfeeding and childcare access. Systemic challenges include inadequate communication to women around implications of health conditions diagnosed in pregnancy, and the importance of postpartum follow up. Uptake of recommended testing after a diagnosis of GDM and HDP is variable but generally suboptimal. Strategies which demonstrate promise include the use of patient navigators, focused education and specialised clinics. Reminder systems have had variable impact. Telehealth and technology are under-utilised in this field but offer promising options particularly with the expansion of virtual healthcare into routine maternity care. Strategies to improve both attendance rates and uptake of testing must be designed to address disparities in healthcare access and tailored to the needs of the community. This review provides a starting point to develop such strategies from the community level to the population level.
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Diabetes Gestacional , Acessibilidade aos Serviços de Saúde , Cuidado Pós-Natal , Humanos , Feminino , Gravidez , Diabetes Gestacional/diagnóstico , Diabetes Gestacional/terapia , Período Pós-Parto , Hipertensão Induzida pela Gravidez/diagnóstico , Hipertensão Induzida pela Gravidez/terapia , Telemedicina , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricosRESUMO
BACKGROUND: Unconfirmed beta-lactam allergy in pregnant people has been associated with higher morbidity, unnecessary exposure to broad-spectrum antibiotics and prolonged hospitalisation. There are no published data on beta-lactam allergies in pregnant people in Australia. AIMS: The aim was to describe patient-reported beta-lactam allergies and appropriateness for antibiotic allergy de-labelling in a maternity cohort in Australia. METHODS: Maternity patients aged ≥18 years admitted to our institution between March 2021 and June 2021 with a beta-lactam allergy documented in their electronic medical record were interviewed for details of their allergy. The documented allergies were compared to the allergy history obtained from the interview. Severity of the allergy was rated, and appropriateness for allergy de-labelling was assessed using the Victorian Therapeutics Advisory Group beta-lactam antibiotic allergy assessment tool. RESULTS: One hundred and fifty-three beta-lactam allergies (182 reactions) were reported by 145 patients. Penicillin class antibiotics were the most frequently implicated, including unspecified penicillins (95/153, 62%), amoxicillin (19/153, 13%) and amoxicillin-clavulanate (8/153, 5%). Allergy documentation required amending in 52 of 145 patients (36%); 85 of 153 (56%) of the beta-lactam allergies were considered low risk and potentially appropriate for direct oral re-challenge. CONCLUSION: Beta-lactam allergies were inaccurately documented in more than one third of the maternity patients included in our study. As such, education of maternity care providers about the importance of accurate allergy history taking remains an urgent unmet need. Furthermore, allergy assessment and de-labelling during pregnancy should be considered in maternity patients to optimise antibiotic prescribing and to improve maternal and neonatal health outcomes.
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Pregnant travellers are often unaware of the various infections that can be acquired during travel and that pregnant people may be at increased risk of severe disease compared to their non-pregnant counterparts. Pregnant people often seek pre-travel counselling from their obstetrician or primary care physicians, who may not be well versed in travel medicine. This paper aims to provide information for maternity care providers regarding important travel-related food, water and mosquito-borne illnesses, including their prevention and treatment methods, equipping maternity care providers to confidently counsel prospective travellers during pregnancy.
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Serviços de Saúde Materna , Doença Relacionada a Viagens , Feminino , Humanos , Gravidez , Aconselhamento , Estudos ProspectivosRESUMO
With international travel on the rise following pandemic restrictions, the number of pregnant travellers is likely to proportionally increase. Recent published data suggest most pregnant travellers seek pre-travel advice from their maternity and primary care providers. With these data, it is important to provide maternity and primary care providers with guidelines and resources to help aid safe, informed, and timely delivery of vaccinations prior to travel. Vaccination for travel during pregnancy is fundamental in mitigating maternal and fetal communicable disease morbidity and mortality. This clinical perspective provides an overview of the indications, safety, and recommendations for pre-travel vaccines in pregnancy.
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Cuidado Pré-Natal , Viagem , Humanos , Feminino , Gravidez , VacinaçãoRESUMO
Travel during pregnancy is common, but is associated with a number of risks and potential problems. There are many pregnancy-specific and destination-specific issues to be considered along with issues related to method of transport. Travel experiences should be made as safe as possible through evidence-based counselling via pregnancy healthcare providers prior to travel. This travelling in pregnancy article has been created to facilitate pregnancy healthcare providers in having these pre-travel discussions to optimise maternal and fetal wellbeing.
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Cuidado Pré-Natal , Viagem , Feminino , Humanos , Gravidez , Feto , VacinaçãoRESUMO
BACKGROUND: Preterm birth (PTB) is one of the leading causes of neonatal mortality and morbidity worldwide. A shortened cervix is a recognised risk factor for PTB, and amniotic fluid sludge (AFS) diagnosed on ultrasound may be suggestive of underlying inflammation or infection. AIMS: The aim is to determine if azithromycin, administered in cases of a shortened cervix, results in prolongation of gestation with improvements in neonatal outcomes. MATERIALS AND METHODS: We performed a retrospective cohort study at three tertiary maternity services in Melbourne, Australia, between 2015 and 2020. Women with a singleton pregnancy were included if they had a cervical length of 15 mm or less at 13-24 weeks' gestation, with or without AFS. Exclusion criteria comprised multiple pregnancy, major fetal congenital anomaly, placenta praevia, prelabour premature rupture of membranes, vaginal bleeding and/or clinical signs suggestive of chorioamnionitis at the time of diagnosis of the short cervix. The results of antibiotic treatment with azithromycin were compared to those of no antibiotic treatment. The outcomes of interest were PTB, prelabour premature rupture of membranes (PPROM), chorioamnionitis and neonatal morbidity. RESULTS: A total of 374 women were included in the study, of whom 129 received azithromycin and 245 received no antibiotics. When adjusting for potential confounders, the adjusted risk of PTB overall was higher in the treatment group (adjusted hazard ratio 1.36 (95% confidence interval 1.04-1.77) P = 0.023) with no differences found for PPROM, chorioamnionitis or neonatal morbidity. CONCLUSION: These data do not support the routine use of azithromycin in women with a short cervix, including those with AFS detected on ultrasound.
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Corioamnionite , Ruptura Prematura de Membranas Fetais , Nascimento Prematuro , Feminino , Gravidez , Recém-Nascido , Humanos , Azitromicina/uso terapêutico , Nascimento Prematuro/etiologia , Corioamnionite/tratamento farmacológico , Corioamnionite/etiologia , Estudos de Coortes , Esgotos , Líquido Amniótico , Estudos Retrospectivos , Colo do Útero/diagnóstico por imagem , Ruptura Prematura de Membranas Fetais/tratamento farmacológico , Antibacterianos/uso terapêuticoRESUMO
Influenza virus circulates year-round, yet uptake of maternal influenza vaccination decreases outside of influenza season. This prospective study of 62 pregnant women provides insight into the possible underlying reasons for this. Despite knowledge of benefits for maternal and infant outcomes, we observed a lack of understanding of rates of influenza infection outside influenza season, concerns about safety in relation to receiving multiple vaccinations during the same pregnancy, and lack of healthcare provider recommendation to be vaccinated outside influenza season. These findings can help tailor public health education targeting pregnant women and their healthcare providers to improve influenza vaccine uptake.
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Vacinas contra Influenza , Influenza Humana , Complicações Infecciosas na Gravidez , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Gravidez , Complicações Infecciosas na Gravidez/prevenção & controle , Gestantes , Estudos Prospectivos , VacinaçãoRESUMO
BACKGROUND: Travel poses risks to pregnant women, but little data exist describing the travel habits of women during pregnancy or pre-travel recommendations given. AIMS: To examine travel patterns of pregnant women including frequency of pre-travel consultation, and advice recalled. MATERIALS AND METHODS: Cross-sectional analysis of post-partum women admitted to five Victorian maternity hospitals between 21 May 2019 and 22 April 2020 in Australia. RESULTS: Forty-four percent (182/410) of women travelled during pregnancy, 32.9% (135/410) interstate and 19.5% (80/410) internationally. Fifty-five percent travelled for leisure (118/215) and 27% to visit friends/relatives (58/215). Overall, 68.1% (124/182) sought pre-travel advice, primarily from an obstetrician (60.5%, 75/124) or general practitioner (29.8%, 37/124). Only one woman attended a travel clinic. The most common reason for not seeking pre-travel advice was the belief that travel posed no risk (63.4%, 45/71). Pre-travel advice was sought least by those visiting friends/relatives (61.4%, 35/57). Women recalled recommendations regarding travel restrictions by gestational age and venous thromboembolism precautions, but not infectious disease prevention for those to whom it was relevant. Of international travellers, 48.8% (39/80) sought advice from the internet, one-third (13/39) as an alternative to seeing a healthcare provider. CONCLUSIONS: Travel is common during pregnancy and women seek pre-travel advice from the healthcare provider they see most often during pregnancy. All pregnant women should be provided with consistent, evidence-based pre-travel advice regardless of whom they consult. Further work is needed to educate and provide resources to maternity care providers to optimise pre-travel counselling.
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Serviços de Saúde Materna , Gestantes , Austrália , Estudos Transversais , Feminino , Humanos , Gravidez , ViagemRESUMO
BACKGROUND: Maternal immunisation is an essential public health intervention aimed at improving the health outcomes for pregnant women and providing protection to the newborn. Despite international recommendations, safety and efficacy data for the intervention, and often a fully funded program, uptake of vaccines in pregnancy remain suboptimal. One possible explanation for this includes limited access to vaccination services at the point of antenatal care. The aim of this study is to evaluate the change in vaccine coverage among pregnant women following implementation of a modified model of delivery aimed at improving access at the point of antenatal care, including an economic evaluation. METHODS: This prospective multi-centre study, using action research design, across six maternity services in Victoria, Australia, evaluated the implementation of a co-designed vaccine delivery model (either a pharmacy led model, midwife led model or primary care led model) supported by provider education. The main outcome measure was influenza and pertussis vaccine uptake during pregnancy and the incremental cost of the new model (compared to existing models) and the cost-effectiveness of the new model at each participating health service. RESULTS: Influenza vaccine coverage in 2019 increased between 50 and 196% from baseline. All services reduced their average cost per immunisation under the new platforms due to efficiencies achieved in the delivery of maternal immunisations. This cost saving ranged from $9 to $71. CONCLUSION: Our study demonstrated that there is no 'one size fits all' model of vaccine delivery. Future successful strategies to improve maternal vaccine coverage at other maternity services should be site specific, multifaceted, targeted at the existing barriers to maternal vaccine uptake, and heavily involve local stakeholders in the design and implementation of these strategies. The cost-effectiveness analysis indicates that an increase in maternal influenza immunisation uptake can be achieved at a relatively modest cost through amendment of maternal immunisation platforms.
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Análise Custo-Benefício , Atenção à Saúde/métodos , Vacinas contra Influenza , Serviços de Saúde Materna , Vacina contra Coqueluche , Cobertura Vacinal/métodos , Austrália , Atenção à Saúde/economia , Feminino , Humanos , Gravidez , Estudos Prospectivos , Cobertura Vacinal/economia , Cobertura Vacinal/tendências , VitóriaRESUMO
BACKGROUND: Infective endocarditis (IE) results in substantial morbidity and mortality in people who inject drugs (PWID). AIMS: To describe the burden of IE and its outcomes in PWID. METHODS: Retrospective cohort study of adults admitted to a tertiary referral centre in Melbourne, Australia, with IE due to injection drug use from 1997 to 2015. RESULTS: Ninety-seven PWID with 127 episodes of IE were identified with a median acute inpatient stay of 37 days (1-84). Admission to an intensive care unit was required in 67/127 (53%) episodes. Twenty-seven percent (34/127) of episodes occurred in patients with a previous episode of endocarditis. One third (43/127, 34%) of episodes involved left-sided cardiac valves. Antimicrobial treatment was completed in 88 (70%) episodes. Valve surgery was performed in 25/127 (20%) episodes. Predictors of surgery in univariable analysis were left-sided cardiac involvement (risk ratio (RR) 6.0), severe valvular regurgitation (RR 2.6) and cardiac failure (RR 2.2) (all P < 0.005). Twenty (16%) episodes resulted in death. Predictors of mortality on univariable analysis were left-sided cardiac involvement (RR 6.4), and not completing treatment (RR 0.12; both P < 0.001). The average estimated cost per episode was AU$74 168. CONCLUSIONS: IE causes a considerable burden of disease in PWID, with significant healthcare utilisation and cost. Surgery and death are not infrequent complications. In addition to ensuring completion of antimicrobial therapy, strategies such as opioid maintenance programmes may be useful in improving health outcomes for PWID.
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Endocardite Bacteriana , Endocardite , Preparações Farmacêuticas , Adulto , Austrália/epidemiologia , Estudos de Coortes , Endocardite/diagnóstico , Endocardite/tratamento farmacológico , Endocardite/epidemiologia , Endocardite Bacteriana/diagnóstico , Endocardite Bacteriana/tratamento farmacológico , Endocardite Bacteriana/epidemiologia , Humanos , Estudos RetrospectivosRESUMO
Background Women comprise ~10% of people living with HIV in Australia, so are often underrepresented in research. METHODS: This study invited clinicians providing care to women living with HIV to complete an anonymous survey containing questions related to four key areas: HIV (including diagnosis, treatment and virological outcomes), reproductive health (including sexual activity, contraception, pregnancy and outcomes) and linkage and retention in care. RESULTS: In total, 484 surveys were received, with responses from all states and territories. Most women living with HIV in Australia are on treatment (>90%) and virologically suppressed (>90% have a viral load <50 copies mL-1). Almost 75% of women have had at least one switch in treatment (with toxicity almost as common as simplification as the indication). Treatment interruption is also relatively common, but is more likely the longer a woman has been diagnosed, if she is on benefits (P = 0.007) and is the primary carer of children without a partner (P = 0.001). In Australia, women living with HIV are a diverse heterogeneous group, with over 70 different countries of birth and almost half speaking a language other than English at home. Mental health diagnosis was the most common co-morbid condition identified. A total of 21% of women were post-menopausal, with 42% reporting symptoms to their healthcare provider, but only 17% were receiving treatment for symptoms attributed to menopause. CONCLUSIONS: As well as strategies to support women vulnerable to treatment interruption, important areas for future investment in research and clinical care include co-morbid mental health and menopause symptoms and treatment.
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Anticoncepção , Substituição de Medicamentos , Infecções por HIV/tratamento farmacológico , Complicações Infecciosas na Gravidez/tratamento farmacológico , Retenção nos Cuidados , Comportamento Sexual , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Austrália/epidemiologia , Comorbidade , Feminino , Infecções por HIV/epidemiologia , Humanos , Transtornos Mentais/epidemiologia , Pessoa de Meia-Idade , Pós-Menopausa , Gravidez , Resultado da Gravidez , Inquéritos e Questionários , Carga Viral , Adulto JovemRESUMO
BACKGROUND: Women's decisions regarding vaccination during pregnancy are heavily influenced by maternity care provider (MCP) recommendations. Understanding why MCPs may not recommend vaccination is central to improving vaccination rates. AIMS: To examine the knowledge, attitudes and practice of Australian MCPs to maternal vaccination. METHODS: We surveyed obstetricians, midwives and general practitioners (GPs) between September and November 2016. Providers were asked about their knowledge and current practice, and about their perceived roles in discussing and administering maternal vaccinations. RESULTS: Eight hundred and seventy surveys were completed. Each MCP group believed they had the primary responsibility for discussing vaccinations but all groups perceived GPs as primarily responsible for administering vaccines. More midwives had concerns about safety (21/129, 16%) than obstetricians (9/359, 3%) and GPs (7/326, 2%) (P < 0.001). Overall, 83% of MCPs recommended diphtheria-tetanus-acellular pertussis vaccination (dTpa) and 78% inactivated influenza vaccination (IIV) according to guidelines, with no differences between groups. Overall 77% provided dTpa onsite (GPs 99%, midwives 70%, obstetricians 60%, P < 0.001) and 71% provided IIV (GPs 99%, midwives 48%, obstetricians 54%, P < 0.001). Factors associated with recommending vaccination in accordance with guidelines and providing vaccination onsite were similar across groups: personal history of vaccination, confidence in vaccine knowledge, and awareness of recommendations for and belief in the safety of maternal dTpa. CONCLUSIONS: Among MCPs, the rates of recommending and providing maternal vaccination were higher than previously reported. Further improvements might be expected with increased awareness of guidelines, further education around vaccine safety, and by changing perceptions of the role of obstetricians and midwives in providing maternal vaccinations.
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Padrões de Prática Médica , Complicações na Gravidez , Cuidado Pré-Natal , Vacinação , Adulto , Austrália , Feminino , Medicina Geral , Humanos , Masculino , Serviços de Saúde Materna , Pessoa de Meia-Idade , Tocologia , Obstetrícia , Gravidez , Inquéritos e QuestionáriosRESUMO
There are no available pharmacokinetic data to guide piperacillin dosing in critically ill Australian Indigenous patients despite numerous reported physiological differences. This study aimed to describe the population pharmacokinetics of piperacillin in critically ill Australian Indigenous patients with severe sepsis. A population pharmacokinetic study of Indigenous patients with severe sepsis was conducted in a remote hospital intensive care unit. Plasma samples were collected over two dosing intervals and assayed by validated chromatography. Population pharmacokinetic modeling was conducted using Pmetrics. Nine patients were recruited, and a two-compartment model adequately described the data. The piperacillin clearance (CL), volume of distribution of the central compartment (Vc), and distribution rate constants from the central to the peripheral compartment and from the peripheral to the central compartment were 5.6 ± 3.2 liters/h, 14.5 ± 6.6 liters, 1.5 ± 0.4 h-1, and 1.8 ± 0.9 h-1, respectively, where CL and Vc were found to be described by creatinine clearance (CLCR) and total body weight, respectively. In this patient population, piperacillin demonstrated high interindividual pharmacokinetic variability. CLCR was found to be the most important determinant of piperacillin pharmacokinetics.
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Antibacterianos/farmacocinética , Havaiano Nativo ou Outro Ilhéu do Pacífico , Piperacilina/farmacocinética , Sepse/tratamento farmacológico , APACHE , Adulto , Antibacterianos/sangue , Peso Corporal , Creatinina/sangue , Estado Terminal , Feminino , Humanos , Unidades de Terapia Intensiva , Masculino , Testes de Sensibilidade Microbiana , Pessoa de Meia-Idade , Piperacilina/sangue , Sepse/etnologia , Sepse/microbiologia , Sepse/patologiaRESUMO
Maternal immunisation is the most effective strategy to reduce infant morbidity and mortality from pertussis infection, and is now standard of care in many countries, including Australia. However, uptake cannot be guaranteed unless the barriers to implementing programs locally are understood. Education and resources for antenatal care providers, embedding vaccination within antenatal care, and provision of culturally appropriate information for pregnant women are integral to a successful antenatal vaccination program.
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Transmissão Vertical de Doenças Infecciosas/prevenção & controle , Cuidado Pré-Natal , Coqueluche/prevenção & controle , Coqueluche/transmissão , Atitude do Pessoal de Saúde , Humanos , Recém-Nascido , Vacina contra Coqueluche/efeitos adversos , Vacinação/efeitos adversos , Coqueluche/imunologiaRESUMO
BACKGROUND: Hepatitis B infection has been associated with the development of gestational diabetes but the underlying mechanism is not known. OBJECTIVE: To examine associations between viral activity, gestational diabetes mellitus (GDM), and insulin resistance in pregnant people with chronic hepatitis B infection (HBV). DESIGN: Prospective cohort study across three tertiary maternity centres in Melbourne, Australia, between May 2021 and April 2023. METHODS: Participants were followed prospectively through pregnancy to evaluate subsequent GDM diagnosis. Demographics, pregnancy outcomes, and markers of viral activity were compared between those with GDM versus those without. Logistic regression analysis was performed pre- and post-adjustment for known confounders. Sub-group analysis of participants from South East Asia (SEA) was performed. Outcome measures included GDM diagnosis, insulin resistance (Homeostatic Model Assessment Insulin Resistance score (HOMA-IR) score), HBV activity as measured by liver function tests, HBV viral load, hepatitis B e antigen, and quantitative hepatitis B surface antigen (quantHBsAg). RESULTS: A total of 113 women were recruited. One third (38/112, 33.9%) developed GDM, mostly diagnosed on isolated postprandial hyperglycaemia (25/38, 65.8%). Over half were born in SEA (66/113, 58.4%). Mean quantHBsAg was significantly lower in those with GDM (p = 0.044). No other associations were identified between GDM or HOMA-IR and markers of hepatic activity on multivariate logistic regression analysis and on sub-group analysis of those born in SEA. CONCLUSIONS: QuantHBsAg was significantly lower in those with GDM; otherwise, no association between GDM and measures of HBV viral activity was found. QuantHBsAg may be useful as an early pregnancy marker for GDM risk and warrants further research.
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Diabetes Gestacional , Resistência à Insulina , Humanos , Feminino , Diabetes Gestacional/epidemiologia , Gravidez , Estudos Prospectivos , Adulto , Vírus da Hepatite B , Austrália/epidemiologia , Complicações Infecciosas na Gravidez/virologia , Complicações Infecciosas na Gravidez/epidemiologia , Hepatite B Crônica/epidemiologia , Carga Viral , Estudos de Coortes , Hepatite B/epidemiologiaRESUMO
An independent association between chronic hepatitis B virus (HBV) and the development of gestational diabetes (GDM) has been reported in the literature. Ethnic background and regional influences have been demonstrated to play a role in the reporting of incidence rates of GDM among women with chronic HBV. The mechanisms behind this association are poorly understood, but evidence suggests an inflammatory basis. Viral factors such as chronic HBV replication, quantifiable by HBV viral load, have been proposed to contribute to the increasing risk of insulin resistance in pregnancy. More research is needed to better characterise the association and determine if any interventions early in pregnancy for women infected with chronic HBV would mitigate the development of GDM.
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BACKGROUND: Pregnant women are at an increased risk of hospitalisation, admission to the intensive care unit, mechanical ventilation, and death from SARS-CoV-2 infection. The aim of this study is to determine the predictive factors associated with COVID-19 vaccine uptake during pregnancy over time in a population with a high background uptake of maternal influenza and pertussis vaccination. METHODS: This is a population-based, cohort study of all pregnant women who gave birth in Victoria, Australia between 1 July 2021 and 30 June 2022. Data from the Victorian Perinatal Data Collection were analysed using univariable and multivariable logistic regression. RESULTS: This study reports on 77,719 women who gave birth over a 12 month period, of whom 49,281 (63.4%) received a COVID-19 vaccine, 54,887 (70.6%) received an influenza vaccination and 63,594 (81.8%) received a pertussis vaccine by the time of delivery. Pregnant women aged >30 years (aOR 1.31 CI 1.27, 1.36), who had >=8 antenatal visits (aOR 1.08 CI 1.04, 1.12), and those who received influenza vaccine (aOR 1.23 CI 1.19, 1.28) were more likely to have received a COVID-19 vaccine. Those who smoked (aOR 0.7 CI 0.66, 0.74), were First Nations (aOR 0.83 CI 0.74, 0.93) and those who gave birth in public hospitals (aOR 0.65 CI 0.63, 0.68) were less likely to receive COVID-19 vaccine in the first 12 months of the rollout. CONCLUSION: Maternal age, smoking, parity and Indigenous status were factors associated with delayed and sustained lower coverage, even in a population with background maternal influenza and pertussis coverage of 70.6% and 81.8%, respectively.
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Maternal immunisation, a low cost and high efficacy intervention is recommended for its pathogen specific protection. Evidence suggests that maternal immunisation has another significant impact: reduction of preterm birth (PTB), the single greatest cause of childhood morbidity and mortality globally. Our overarching question is: how does maternal immunisation modify the immune system in pregnant women and/or their newborn to reduce adverse pregnancy outcomes and enhance the newborn infant's capacity to protect itself from infectious diseases during early childhood? To answer this question we are conducting a multi-site, prospective observational cohort study collecting maternal and infant biological samples at defined time points during pregnancy and post-partum from nulliparous women. We aim to enrol 400 women and determine the immune trajectory in pregnancy and the impact of maternal immunisation (including influenza, pertussis and/or COVID-19 vaccines) on this trajectory. The results are expected to identify areas that can be targeted for future intervention studies.
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Imunização , Nascimento Prematuro , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Gravidez , Imunidade , Estudos Observacionais como Assunto , Estudos ProspectivosRESUMO
Since its discovery in late 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been estimated to be responsible for at least 769.3 million infections and over 6.95 million deaths. Despite significant global vaccination efforts, there are limited therapies that are considered safe and effective for use in the management of COVID-19 during pregnancy despite the common knowledge that pregnant patients have a much higher risk of adverse outcomes. A bioactive compound found in broccoli sprout-sulforaphane-is a potent inducer of phase-II detoxification enzymes promoting a series of potentially beneficial effects notably as an antioxidant, anti-inflammatory, and anti-viral. A pilot, double-blinded, placebo-controlled randomised trial is to be conducted in Melbourne, Australia, across both public and private hospital sectors. We will assess a commercially available broccoli sprout extract in pregnant women between 20+0 and 36+0 weeks gestation with SARS-CoV-2 infection to investigate (i) the duration of COVID-19 associated symptoms, (ii) maternal and neonatal outcomes, and (iii) biomarkers of infection and inflammation. We plan to enrol 60 outpatient women with COVID-19 irrespective of vaccination status diagnosed by PCR swab or RAT (rapid antigen test) within five days and randomised to 14 days of oral broccoli sprout extract (42 mg of sulforaphane daily) or identical microcrystalline cellulose placebo. The primary outcome of this pilot trial will be to assess the feasibility of conducting a larger trial investigating the duration (days) of COVID-19-associated symptoms using a broccoli sprout supplement for COVID-19-affected pregnancies. Pregnant patients remain an at-risk group for severe disease following infection with SARS-CoV-2 and currently unclear consequences for the offspring. Therefore, this study will assess feasibility of using a broccoli sprout supplement, whilst providing important safety data for the use of sulforaphane in pregnancy.