Equity in coronavirus disease 2019 vaccine development and deployment.

The coronavirus disease 2019 pandemic exposed weaknesses in multiple domains and widened gender-based inequalities across the world. It also stimulated extraordinary scientific achievement by bringing vaccines to the public in less than a year. In this article, we discuss the implications of current vaccination guidance for pregnant and lactating women, if their exclusion from the first wave of vaccine trials was justified, and if a change in the current vaccine development pathway is necessary. Pregnant and lactating women were not included in the initial severe acute respiratory syndrome coronavirus 2 vaccine trials. Therefore, perhaps unsurprisingly, the first vaccine regulatory approvals have been accompanied by inconsistent advice from public health, governmental, and professional authorities around the world. Denying vaccination to women who, although pregnant or breastfeeding, are fully capable of autonomous decision making is a throwback to a paternalistic era. Conversely, lack of evidence generated in a timely manner, upon which to make an informed decision, shifts responsibility from research sponsors and regulators and places the burden of decision making upon the woman and her healthcare advisor. The World Health Organization, the Task Force on Research Specific to Pregnant Women and Lactating Women, and others have highlighted the long-standing disadvantage experienced by women in relation to the development of vaccines and medicines. It is uncertain whether there was sufficient justification for excluding pregnant and lactating women from the initial severe acute respiratory syndrome coronavirus 2 vaccine trials. In future, we recommend that regulators mandate plans that describe the development pathway for new vaccines and medicines that address the needs of women who are pregnant or lactating. These should incorporate, at the outset, a careful consideration of the balance of the risks of exclusion from or inclusion in initial studies, patient and public perspectives, details of "developmental and reproductive toxicity" studies, and approaches to collect data systematically from participants who are unknowingly pregnant at the time of exposure. This requires careful consideration of any previous knowledge about the mode of action of the vaccine and the likelihood of toxicity or teratogenicity. We also support the view that the default position should be a "presumption of inclusion," with exclusion of women who are pregnant or lactating only if justified on specific, not generic, grounds. Finally, we recommend closer coordination across countries with the aim of issuing consistent public health advice.

The first-trimester of pregnancy - A window of opportunity for prediction and prevention of pregnancy complications and future life.

The International Federation of Gynecology and Obstetrics (FIGO) has identified non communicable maternal diseases (NCDs) as a new focus area. NCDs and exposures as related to pregnancy complications and later impairment of maternal and offspring health will form the basis for action in the forthcoming years. This paper summarizes recent advances, centered on the use of first-trimester testing, as a window of opportunity to predict and prevent many pregnancy complications; and for potential future prevention of NCDs in mother and offspring. Recent results from a large-scale randomized control trial have provided definitive proof that effective screening for preterm preeclampsia (preterm-PE), requiring delivery before 37 weeks' gestation, can be achieved with a combined test of maternal factors and biomarkers at 11-13 weeks and that aspirin, given to high-risk women, is effective in reducing the risk of preterm-PE and the length of stay in neonatal intensive care unit. This is the first successful example to illustrate that pregnancy complications is predictable and preventable in early pregnancy. Similar prediction and prevention strategies are being developed for hyperglycemia in pregnancy and preterm birth, with the intention for longer lasting interventions leading to significant downstream impact in improving long-term health in both mothers and babies.

Characterizing the Pattern of Anomalies in Congenital Zika Syndrome for Pediatric Clinicians.

Importance: Zika virus infection can be prenatally passed from a pregnant woman to her fetus. There is sufficient evidence to conclude that intrauterine Zika virus infection is a cause of microcephaly and serious brain anomalies, but the full spectrum of anomalies has not been delineated. To inform pediatric clinicians who may be called on to evaluate and treat affected infants and children, we review the most recent evidence to better characterize congenital Zika syndrome. Observations: We reviewed published reports of congenital anomalies occurring in fetuses or infants with presumed or laboratory-confirmed intrauterine Zika virus infection. We conducted a comprehensive search of the English literature using Medline and EMBASE for Zika from inception through September 30, 2016. Congenital anomalies were considered in the context of the presumed pathogenetic mechanism related to the neurotropic properties of the virus. We conclude that congenital Zika syndrome is a recognizable pattern of structural anomalies and functional disabilities secondary to central and, perhaps, peripheral nervous system damage. Although many of the components of this syndrome, such as cognitive, sensory, and motor disabilities, are shared by other congenital infections, there are 5 features that are rarely seen with other congenital infections or are unique to congenital Zika virus infection: (1) severe microcephaly with partially collapsed skull; (2) thin cerebral cortices with subcortical calcifications; (3) macular scarring and focal pigmentary retinal mottling; (4) congenital contractures; and (5) marked early hypertonia and symptoms of extrapyramidal involvement. Conclusions and Relevance: Although the full spectrum of adverse reproductive outcomes caused by Zika virus infection is not yet determined, a distinctive phenotype-the congenital Zika syndrome-has emerged. Recognition of this phenotype by clinicians for infants and children can help ensure appropriate etiologic evaluation and comprehensive clinical investigation to define the range of anomalies in an affected infant as well as determine essential follow-up and ongoing care.

Rastreamento de aneuploidias no primeiro trimestre de gestação: evolução da idade materna à avaliação do DNA fetal livre no sangue materno / Screening for aneuploidies in the first trimester of pregnancy: evolution from maternal age to cell-free DNA testing in maternal blood

O rastreamento fetal de aneuploidia apresentou uma evolução fantástica a partir da avaliação individual da idade materna até os dias atuais, na qual evidências sugerem que o teste de avaliação do DNA fetal livre no sangue materno detecta mais de 99% dos casos de trissomia do cromossomo 21 e, aproximadamente, 98% dos casos de trissomia do 18 e 92%, do 13, com taxas de falso-positivo de 0,1; 0,1 e 0,3%, respectivamente. Recentemente, o grupo de trabalho em boas práticas médicas da Federação Internacional de Ginecologia e Obstetrícia recomendou que todas as gestantes, independentemente da idade, deveriam realizar uma avaliação de risco para aneuploidias por meio da translucência nucal, do teste combinado ou do teste de DNA fetal livre no sangue materno. O teste invasivo para diagnóstico de aneuploidia não deveria ser realizado considerando apenas a idade materna como fator de risco. O objetivo desta revisão foi apresentar esta nova ferramenta de rastreio, presente em muitos centros, e descrever as estratégias para implementação de tal tecnologia na prática clínica diária.(AU)

Screening for fetal aneuploidy has a tremendous evolution from maternal age to now where recent evidence suggests that cell-free DNA testing in maternal blood can detect more than 99% of cases of trisomy 21, about 98% of trisomy 18, and 92% of trisomy 13, with respective false-positive rates of 0.1, 0.1, and 0.3%. Recently, the working group on the best practice on maternal fetal medicine of the International Federation of Gynecology and Obstetrics has recommended as a good medical practice that pregnant women, regardless of maternal age, be offered prenatal assessment for aneuploidy through nuchal translucency, combined test, or cell-free DNA testing. The invasive procedure for diagnosis of aneuploidy should be avoided taking into account only the maternal age as a risk factor nowadays. The purpose of this review was to present this new screening tool available in most centers and to describe the strategies for implementation of this technology on the daily clinical practice.(AU)

Predição e prevenção do parto pré-termo / Prediction and prevention of preterm delivery

A prevenção da prematuridade é um dos maiores desafio obstétricos deste século, e as medidas preventivas do parto prematuro se baseiam em três níveis de ação: a prevenção primária (identificação e tratamento dos fatores de risco), secundária (diagnóstico precoce do trabalho de parto prematuro) e terciária (intervenções para minimizar as principais complicações do nascimento prematuro). A maioria dos esforços está concentrada na prevenção terciária (utilização de tocólise e corticoide). Tais medidas reduzem a mortalidade e morbidade perinatal, mas a incidência do nascimento prematuro permanece alta. Avanços na prevenção primária e secundária, seguidos de novas estratégias, são necessários para diminuir a incidência do parto prematuro e para prevenir as doenças associadas à prematuridade. O objetivo desta revisão é descrever os métodos de predição do parto prematuro mais utilizados e as principais medidas preventivas do nascimento prematuro.

The prevention of preterm birth is the most important challenge at present time. The interventions to reduce the morbidity and mortality of preterm birth can be primary (identification and treatment of risk factors), secondary (early diagnosis of preterm labor), or tertiary (intended to improve outcomes for preterm infants). Most efforts so far have been tertiary interventions, such as treatment with tocolytic agents and antenatal corticosteroids. These measures have reduced perinatal morbidity and mortality, but the incidence of preterm birth remains high. Advances in primary and secondary care, following new strategies, are needed to prevent prematurity-related illness in infants and children. The purpose of this review is to describe the useful methods of prediction of preterm delivery and the most important measures to prevent the preterm birth.

Evaluation of the risk of spreading endometrial cell by hysteroscopy: a prospective longitudinal study.

Objective. The aim was to assess the intraperitoneal spread of endometrial cells during hysteroscopy. Study Design. Seventy-six women were submitted to a hysteroscopy with CO(2) under a low pressure. Group 1 had not previous diagnosis of endometrial cancer, and group 2 had previous diagnosis of endometrial cancer (stage I-92.3%). Two peritoneal washing samples were taken before (PW1) and immediately after (PW2) the procedure. The dissemination for the peritoneal cavity was defined by the presence of endometrial cells in the PW2; such cells should be absent in WP1. Results. Four patients were excluded for presenting endometrial cells in PW1. In the 72 patients left, there was no passage of cells for the peritoneal cavity. In group 1, 88% presented secretory endometrial phase with correlation of 80% between hysteroscopy and biopsy. Conclusion. Hysteroscopy performed under a low pressure of CO(2) does not cause spreading of endometrial cells into the peritoneal cavity.