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Because of their developmental toxicity, some antiseizure medication (ASM) should be avoided during pregnancy. This may lead to discontinuation or switching of ASM after recognition of pregnancy, but some of these changes may be suboptimal. Trends in ASM use at conception were analyzed in 3,763 pregnancies prospectively ascertained by a teratology information service in Germany between 2000 and 2018. Focusing on women with epilepsy (n = 2,395), changes of treatment pattern during the 1st trimester were evaluated. There was an increase in women using ASMs for non-epilepsy indications from 19% in 2000 to 39% in 2018. Although a shift from non-recommended teratogenic ASMs to recommended ASMs was observed, 13% of women were still receiving non-recommended ASMs in early pregnancy at the end of the study period. Among women with epilepsy, ASM regimen remained unchanged during the 1st trimester in 90%, 6% switched to other ASMs, and only 4% discontinued. Valproate, oxcarbazepine, and topiramate were more likely to be discontinued or switched than other ASMs. This first analysis of treatment pattern in ASM exposed pregnancies in Germany confirms the general trend towards less teratogenic and newer ASMs. However, it remains questionable whether women still using non-recommended ASMs are refractory to lower-risk ASMs or disregard treatment guidelines and risk minimization measures. [ABSTRACT FROM AUTHOR]

Background: Pregnant women have a higher risk of severe illness and adverse pregnancy outcomes due to a SARS-CoV-2 infection. COVID-19 vaccination can prevent (severe) infection. Observational studies are needed to ascertain safety of COVID-19 vaccination during pregnancy. Aim: Estimate whether COVID-19 vaccination during pregnancy is associated with the risk of preterm labor (PL). Methods: In this prospective cohort study, we included 5,910 pregnant women (mean age: 33.0 ± 3.7 years) who entered the Dutch Pregnancy Drug Register between February 2021 and August 2022. Information on COVID-19 vaccinations, PL, and confounders were self-reported using web-based questionnaires. The hazard ratio (HR) on PL, comparing those who received ≥1 COVID-19 vaccine during any moment of pregnancy to those who did not, was estimated using survival analyses with vaccination as time-varying exposure. Additionally, we estimated the risk of PL after COVID-19 vaccination prior to pregnancy, and after COVID-19 vaccination during trimester 1, 2, or 3 of pregnancy. Findings: A total of 5,227 (88%) participants received ≥1 COVID-19 vaccine between gestational week 2 and 37. We observed no statistically significant association of COVID-19 vaccination during pregnancy (adjusted HR = 0.93, 95%CI = 0.59; 1.45) nor of COVID-19 vaccination prior to pregnancy (adjusted HR = 1.09, 95%CI = 0.70; 1.71) with the risk of PL. Moreover, we observed no association between the risk of PL and COVID-19 vaccination in any trimester of pregnancy. Discussion: We demonstrated that COVID-19 vaccination prior to or during pregnancy is not associated with an increased risk of PL. Conclusion: These results add to the growing evidence supporting safety of COVID-19 vaccination during pregnancy. [ABSTRACT FROM AUTHOR]

To assess the risk of exposure to a medicinal product during pregnancy in an individual case report, the necessary information should be present, complete and clearly described. Previously designed grading tools were not developed for pregnancy pharmacovigilance data. This study aims to identify the elements that are necessary to assess of the quality of information for risk assessment of medicinal products used during pregnancy. This is a first step in the development of a validated method to assess the clinical quality of case reports in pregnancy pharmacovigilance data. Potential information elements were determined by means of an expert focus group discussion and a survey based on its outcome. This provided an overview of possible information elements to be selected. For the final selection of the elements, a second survey and subsequent focus group discussion was used. Twenty-one information elements within seven categories were identified: information related to the association itself, the event, exposure to the medicinal product, maternal factors, pregnancy, labour, and the child. This study identified elements considered necessary in the assessment of quality of information of case reports in pregnancy pharmacovigilance data, via an extensive four-step process. [ABSTRACT FROM AUTHOR]

Eighteen new cases of teratology and other abnormalities within scorpions are presented, representing new cases of metasomal duplication, mesosomal anomaly, telson anomaly, albinism, and abnormal pigmentation. Furthermore, recently published literature on other scorpion anomalies are tabulated to update the recent 2023 checklist of scorpion teratology which charted all known literature up to the aforementioned work. [ABSTRACT FROM AUTHOR]

The state of knowledge regarding the teratogenic effects of maternal use of medications during pregnancy is constantly evolving and is often uncertain. Timely access to high-quality information may reduce prolonged harmful exposures, decrease the number of preventable birth defects, empower patients with accurate information about the risks of exposure, and prevent unnecessary patient anxiety and pregnancy termination. In this narrative review, we describe the process by which the teratogenic risk of medications is assessed by experts in medicine, genetics, and epidemiology and how identifiable risks can be effectively communicated to patients. Risk assessment of birth defects in human pregnancy involves collecting and synthesizing available data through a proper and rule-driven evaluation of scientific literature. Expert consensus is a practical approach to determine whether a given exposure produces damage after careful consideration of gestational timing, dose and route of the exposure, maternal and fetal genetic susceptibility, as well as evidence for biological plausibility. The provision of teratogen risk counseling through appropriate interpretation of information and effective knowledge translation to the patient is critical for the prevention of birth defects and maximizing healthy pregnancies. [ABSTRACT FROM AUTHOR]

Background: Heavy metals like lead (Pb) have been used by humans for a very long time, but throughout the industrial revolution, their use expanded, increasing exposure to the metal. Lead, however, has no biological purpose in the human body and is hazardous when it gets into soft tissues and organs. Lead is still used in a variety of industries, including battery manufacturing and car maintenance, despite efforts to limit its usage. Objective: This study investigates the teratogenic and morphometric effects of lead on chick embryos and the potential ameliorative effects of vitamin B6. Methods: Two hundred fertilized eggs from the golden black chicken were divided into four groups: control, lead acetate, vitamin B6, and lead + vitamin B6. Results: On the 14th day, embryos were analyzed. Significant reductions in body weight and size were observed in the lead‐exposed group (33.93 ± 1.27 g) compared to the control (41.12 ± 0.97 g). Pronounced deformities included rudimentary beaks, protruding eyes, tridactyl limbs, hydrocephaly, and neck deformities. Appendicular deformities like phocomelia, amelia, and abnormal phalanges growth were also noted. Vitamin B6 demonstrated therapeutic benefits, significantly improving mean embryo weight in the Lead + Vitamin B6 group (42.37 ± 0.99 g). The lead‐exposed group showed a reduction in maxilla length (3.61 ± 1.30 mm) compared to the Lead + Vitamin B6 group (7.57 ± 0.79 mm). This group also showed reduced severity of muscular dystrophy and bone thinning, with signs of recovery in beak and bone sizes. Conclusions: The study highlights vitamin B6's beneficial impact in mitigating lead's toxic effects on chick embryonic development. [ABSTRACT FROM AUTHOR]

Assessing the embryotoxicity and teratogenicity of various substances and processes is crucial due to their complexity and resource intensity. The chicken embryo (CE) serves an ideal model for simulating the first months of mammalian embryonic development. This makes the CE a reliable model for testing teratogenic effects, particularly in relation to the nervous system (NS), which experiences developmental abnormalities second in frequency only to cardiovascular teratogenic disorders. Microcomputed tomography (μCT) is a promising method for studying these processes. The advantages of μCT include relatively high research speed, diagnostic accuracy, high resolution and the ability to visualize the entire internal 3D structure of an object while preserving for other types of research. At the same time, there are practically no available databases of normative μCT data, both qualitative and quantitative, which would act as a starting point for screening detection of abnormalities in the development of the NS. In this study, we present a simple method for obtaining very detailed quantitative sets of 2D and 3D μCT data of NS structures of the CE (Gallus Gallus domesticus) at HH22-HH41 embryonic stages with contrasting by 1% phosphotungstic acid. The results of μCT demonstrate the exact boundaries, high general and differentiated contrast of the main and specific structures of the NS of CE, which are quantitatively and qualitatively similar to results of histological analysis. Calculations of the X-ray density and volume of the main structures of the NS at constant exponential growth are presented. In addition to the increase in linear dimensions, significant changes in the structures of various parts of the brain were identified and visualized during the CE development at HH22 to HH41 embryonic stages. The data presented establish the first methodology for obtaining normative data, including subtle localized differences in the NS in CE embryogenesis. The data obtained open up new opportunities for modern embryology, teratology, pharmacology and toxicology. [ABSTRACT FROM AUTHOR]

[Display omitted] • Phased transition of plant communities across Permian–Triassic boundary. • Increase in volcanogenic heavy metals at Permian–Triassic boundary. • Evidence for heavy metal-induced plant mutagenesis on northern Pangaea. The end-Permian extinction (EPE) (∼251.9 Ma) is considered the most severe biotic crisis in Earth's history. Rapid climatic change and oceanic acidification triggered by Siberian Traps volcanism culminated in a widely documented mass extinction in the marine realm, but the event's impact on terrestrial ecosystems, particularly plant communities, is less well understood. While the existence of a floral mass extinction at the Permian-Triassic Boundary (PTB) is still debated, there is mounting evidence for pervasive mutagenesis among various plant lineages, as expressed by the high incidence of aberrant spores and pollen grains. Previous studies have proposed a causal relationship between increased UV-B flux and plant mutagenesis across the PTB, yet the role of volcanically derived heavy metals as a contributing factor has received considerably less attention. Here we present the results of a high-resolution palynological, sedimentological, and geochemical analysis of a continuous and previously unstudied PTB section from the Norwegian Arctic. The study reveals an abrupt increase in the levels of heavy metals across the EPE negative carbon isotope excursion (CIE). Palynological analysis indicates disruption, and a phased transition of plant communities at the PTB, without a significant turnover in species or decrease in diversity. However, the abrupt appearance and elevated abundance of aberrant palynomorphs coincides with increased concentrations of As, Co, Hg, and Ni, which is interpreted as compelling evidence for heavy metal-induced stress and genetic disturbance in plant communities during the EPE. We hypothesise that biomagnification of these elements may have been a significant driver for the end-Permian biotic crisis. Our findings are correlated via biostratigraphy and chemostratigraphy with other circum-Arctic PTB sections described in the literature, demonstrating the isochroneity and facies independence of these widespread palaeoecological changes. [ABSTRACT FROM AUTHOR]

This paper offers an historical introduction to Pere Alberch's evolutionary thought and his contributions to Evo-Devo, based on his unique approach to experimental teratology. We will take as our point of reference the teratogenic experiments developed by Alberch and Emily A. Gale during the 1980s, aimed at producing monstrous variants of frogs and salamanders. We will analyze his interpretation of the results of these experiments within the framework of the emergence of evolutionary developmental biology (or "Evo-Devo"). The aim is understand how Alberch interpreted teratological anomalies as highly revealing objects of study for understanding the development of organic form, not only in an ontogenetic sense—throughout embryonic development—but also phylogenetically—throughout the evolution of species. Alberch's interpretation of monsters reflects the influence of a long tradition of non-Darwinian evolutionary thought, which began in the nineteenth century and was continued in the twentieth century by people such as Richard Goldschmidt, Conrad H. Waddington, and Stephen Jay Gould. They all proposed various non-gradualist models of evolution, in which embryonic development played a central role. Following this tradition, Alberch argued that, in order to attain a correct understanding of the role of embryological development in evolution, it was necessary to renounce the gradualist paradigm associated with the Darwinian interpretation of evolution, which understood nature as a continuum. According to Alberch, the study of monstrous abnormalities was of great value in understanding how certain epigenetic restrictions in development could give rise to discontinuities and directionality in morphological transformations throughout evolution. [ABSTRACT FROM AUTHOR]

In recent years, psychedelics have garnered significant interest as therapeutic agents for treating diverse neuropsychiatric disorders. However, the potential for these compounds to produce developmental neurotoxicity has not been rigorously assessed, and much of the available safety data is based on epidemiological studies with limited experimental testing in laboratory animal models. Moreover, the experimental safety data available thus far have focused on adult organisms, and the few studies conducted using developing organisms have tested a limited number of compounds, precluding direct comparisons between various chemical scaffolds. In the present study, 13 psychoactive compounds of different chemical or pharmacological classes were screened in a larval zebrafish model for teratological and behavioral abnormalities following acute and chronic developmental exposures. We found that the psychedelic tryptamines and ketamine were less neurotoxic to larval zebrafish than LSD and psychostimulants. Our work, which leverages the advantage of using zebrafish for higher throughput toxicity screening, provides a robust reference database for comparing the neurotoxicity profiles of novel psychedelics currently under development for therapeutic applications.

Purpose: Chicken embryos serve as a prominent model in embryonic development research. The present study evaluates the developmental impact of Lambda-Cyhalothrin and Methylcobalamin (Vitamin B12) on Gallus domisticus chick embryos. Methods: 250 fertilized eggs of Gallus domesticus were distributed into five groups: i) Control group (CG): incubated without any treatment ii) Vehicle Control group (VC): injected with 0.1mL of a 5% DMSO solution in water iii) Lambda-Cyhalothrin group (LCH): injected with 0.1mL of 0.01mg/kg LCH solution in 5% DMSO iv) Vitamin B12 group (B12): injected with 0.1mL of 0.1mg/kg vitamin B12 solution in 5% DMSO v) Lambda-Cyhalothrin group + Vitamin B12 (LCH+B12): injected with 0.1mL of 0.01 mg/kg LCH 0.1mg/kg vitamin B12 solution. Treatment was given on zero day and embryos were recovered on 14th day after incubation to check embryonic development. Results: Morphological observations indicated that both the CG and VC groups displayed normal development. In contrast, the LCH and LCH+B12 group exhibited adverse effects, which included embryonic cataracts, neck deformities, muscular dystrophy, and a higher rate of embryo mortality when compared to the CG and VC groups. Moreover, LCH+B12 group also showed severe synergistic embryonic toxicity, characterized by halted development, foul odor, sulfur contents, blackish discoloration and teratogenic signs including embryonic cataract, evisceration, halted neck, hemorrhage spot and reduced limb size. Conclusion: Type-II fluoridated pyrethroid LCH is highly toxic to chick development. Study revealed that Vitamin B12 alone does not interfere with normal development however its co-treatment with LCH can aggravate toxic potentials of LCH for embryonic development in the chick. [ABSTRACT FROM AUTHOR]

The present article develops an examination of the main aspects to be considered in the analysis that the philosophies of G. Canguilhem and M. Foucault devote to the problem of madness. The text stipulates the philosophical conditions of approach that both authors elaborate on to think about the problem of norms in the vital and social sphere. The question: what is crazy? then becomes the question of the social and political practices that have been developed concerning madmen and madness, evidencing the relevance that Canguilhem and Foucault give to the problem of norms, either in an ontological and/or historical-political framework of understanding. [ABSTRACT FROM AUTHOR]

Objective: This study was undertaken to assess the utility of the Ages and Stages Questionnaire–3rd Edition (ASQ‐3) and the Vineland Adaptive Behavior Scales–2nd Edition (VABS‐II) as neurodevelopmental screening tools for infants exposed to antiseizure medications in utero, and to examine their suitability for use in large‐population signal generation initiatives. Methods: Participants were women with epilepsy who were recruited from 21 hospitals in England and Northern Ireland during pregnancy between 2014 and 2016. Offspring were assessed at 24 months old using the Bayley Scales of Infant Development–3rd Edition (BSID‐III), the VABS‐II, and the ASQ‐3 (n = 223). The sensitivity and specificity of the ASQ‐3 and VABS‐II to identify developmental delay at 24 months were examined, using the BSID‐III to define cases. Results: The ASQ‐3 identified 65 children (29.1%) as at risk of developmental delay at 24 months using standard referral criteria. Using a categorical approach and standard referral criteria to identify delay in the ASQ‐3 and BSID‐III at 24 months, the ASQ‐3 showed excellent sensitivity (90.9%) and moderate specificity (74.1%). Utilizing different cut‐points resulted in improved properties and may be preferred in certain contexts. The VABS‐II exhibited the strongest psychometric properties when borderline impairment (>1 SD below the mean) was compared to BSID‐III referral data (sensitivity = 100.0%, specificity = 96.6%). Significance: Both the ASQ‐3 and VABS‐II have good psychometric properties in a sample of children exposed to antiseizure medications when the purpose is the identification of at‐risk groups. These findings identify the ASQ‐3 as a measure that could be used effectively as part of a tiered surveillance system for teratogenic exposure by identifying a subset of individuals for more detailed investigations. Although the VABS‐II has excellent psychometric properties, it is more labor‐intensive for both the research team and participants and is available in fewer languages than the ASQ‐3. [ABSTRACT FROM AUTHOR]

The Rhomaleosauridae were a clade of Jurassic plesiosaurians, characterized by triangular skulls, an elongated preorbital region, marked premaxillary-maxillary constriction, and intermediate body proportions that fall between pliosauromorphs and plesiosauromorphs. Despite recent progress in the study of dental replacement in plesiosaurians, the replacement features in rhomaleosaurids have not been studied yet. Here, the dental features of the rhomaleosaurid Maresaurus coccai Gasparini, 1997 are described and analyzed based on the holotype specimen. Regarding symmetry, it was determined that M. coccai shows symmetrical replacement in the maxillary-premaxillary and asymmetrical replacement in the dentary. Additionally, the tooth replacement cycle period (TRCP) of two alveoli was determined for the dental series, except for the anterior part of the left mandibular ramus, which presents an TRCP of three, an asymmetry considered here as teratology. This result indicates that the replacement cycle period (TRCP) of the two alveoli would correspond to a primitive character for Plesiosauria, displaying an increase of TRCP from two to three alveoli in taxa comparatively more derived within Pliosauridae. [ABSTRACT FROM AUTHOR]

Simple Summary: Congenital defects have been described in almost every vertebrate group. In crocodiles, teratology alterations have been described in captive animals (pets, zoos, farms) such as Crocodylus niloticus and Gavialis gangeticus. The present study aimed to characterize congenital malformations of C. acutus from a farm in Lomas de Matunilla, Ballestas, Bolívar, Colombia. The analyzed eggs presented macroscopic malformations, with 42 different types of anomalies observed. Limb and tail malformations (29%) were the most common changes observed. The American crocodile (Crocodylus acutus, Cuvier, 1807) (Class Reptilia, Family Crocodylidae) is a crocodile species inhabiting the Neotropics. Congenital defects have been described in almost every vertebrate group. In crocodiles, teratology alterations have been described in captive animals (pets, zoos, farms) such as Crocodylus niloticus or Gavialis gangeticus. The present study aimed to characterize congenital malformations of C. acutus from a farm in Lomas de Matunilla, Ballestas, Bolívar, Colombia. A total of 550 unhatched eggs were examined after embryo death. A total of 61 embryos presented malformations, with 42 different types of anomalies observed. Limb and tail malformations (29%) were the most common malformations observed. Several malformations, such as cephalothoracopagus, thoracopagus, sternopagus, xiphopagus twins, campylorrachis scoliosa, and acrania, were documented in crocodiles for the first time. Research in teratology enhances our understanding of crocodile biology. It plays a role in their conservation and management, thus helping to ensure the long-term viability of these species in their natural habitats. [ABSTRACT FROM AUTHOR]

Cadmium (Cd) is a heavy metal and a significant inorganic toxin that is commonly found throughout the environment. The human body, as well as the kidneys, tend to accumulate Cd. Research conducted on both humans and animals suggests that exposure to cadmium can lead to significant skeletal damage, specifically osteoporosis. Based on the prevalence of cadmium in the environment and its frequent use, we studied the effect of its toxicity on pregnant rat and their fetuses and the effect of zeolite on them. The experimental rats were divided into 5 groups (n=8, each). The 1st group received distilled water as a normal control group. The 2nd received tween80 and served as tween80 group. The 3rd was administrated with zeolite dissolved in tween80then in distilled water at a dose (100mg\kg\day). The 4th was administrated with cadmium chloride at dose (30mg\kg\day). The 5th was administrated with a combination of both zeolite and cadmium chloride. All groups were administered the materials orally from the 6th day to the 15th day of gestation. All animals were sacrificed at the end of gestation periods (on the 20th day). Our obtained results showed adverse histological alterations in maternal and fetal kidneys. Also, CdCl2 (cadmium chloride) induced remarkable changes in the levels of kidney functions.  On the other hand, results showed incomplete ossification of the skull, metacarpals, and phalanges of the toes of fetuses’ skeletons. Zeolite administration markedly ameliorated the altered renal histological and physiological changes as well as the skeletal deformity in fetuses induced by cadmium. [ABSTRACT FROM AUTHOR]

Anti-tuberculosis drugs rifampicin and pyrazinamide combination in pregnancy can cause morphological, visceral and skeletal damage. Several studies showed that propolis improves pregnancy outcomes. This study aims to determine the fetal protective effect of propolis in BALB/c mice given the anti-tuberculosis drug combination rifampicin and pyrazinamide. A total of 21 pregnant mice were randomly divided into three groups: the normal group (N) was given distilled water as a vehicle, the positive control group (RP) were given rifampicin 15 mg/kg BW, pyrazinamide 35 mg/kg BW and the treatment group (IP) were given rifampicin 15 mg/kg BB, pyrazinamide 35 mg/kg BW and propolis 400 mg/kg BW. The treatment was given during the period of organogenesis, from day 6 to day 15. Laparotomy was performed on the 18th day of pregnancy. Maternal and fetal body weight, fetal length, number of fetuses, and skeletal defects of fetuses were used as parameters to identify the teratogenic effect. All data were analyzed using the ANOVA. All groups significantly differed between maternal and fetal body weights (p<0.05). The administration of rifampicin-pyrazinamide and propolis during pregnancy did not significantly affect the number of fetuses (p>0.05). The administration of propolis protects the fetus from skeletal abnormalities. While in the RP and IP groups, we can find resorption sites and haemorrhagic. This study may suggest the protective effects of propolis against rifampicin pyrazinamide-induced impaired pregnancy. [ABSTRACT FROM AUTHOR]

Fossil (zoo)plankton dynamics during Devonian ocean‐anoxic and extinction events can shed light on the palaeoceanographic and geochemical processes that shaped the middle Palaeozoic biosphere. However, datasets on (Upper) Devonian marine palynology, illustrating such dynamics, remain underexplored. The type section of the Sweetland Creek Shale in Iowa (USA) offers a detailed conodont zonation for the upper Frasnian and across the Frasnian–Famennian boundary, records the Upper and Lower Kellwasser events and has pristine preservation of organic material, making this an ideal section to study the effects of this catastrophic event on chitinozoan zooplankton populations. A total of 3998 specimens were recovered, imaged and classified into 12 distinct species, 10 of which were previously unknown. This study demonstrates the unrealized potential of chitinozoans as a regional biostratigraphic tool in the Upper Devonian. The Lower Kellwasser Event is characterized by a drop in chitinozoan abundance and the run up to the Upper Kellwasser Event marks a period of rapid species turnover rates. Interestingly, every assemblage in this interval is nearly monospecific. Patterns of changing spine morphologies in Fungochitina pilosa, Ramochitina sp. A and Saharochitina sp. A are herein explored as potential ecophenotypic expressions. We identify Angochitina monstrosa as a new disaster species. The discovery of two teratological chitinozoans specimens, in combination with the presence of the disaster species Angochitina monstrosa and deformation in contemporaneous conodonts, supports our previous discovery that marine teratology is a feature of many Palaeozoic extinction events, possibly triggered by the injection of hydrothermal brines into the ocean. [ABSTRACT FROM AUTHOR]

Conjoined twins (CTs), popularly referred to as Siamese twins, are a rare anomaly due to monochorionic and monoamniotic twin pregnancies. Dicephalus dibrachius dipus, a type of parapagus conjoined twin which is characterized by possessing two arms, two legs, a single trunk and two heads, epidemiologically, is an even rarer occurrence of CTs. In this article, a rare, well-preserved anatomical specimen of a dicephalus dibrachius dipus conjoined twin is presented. This study was conducted in a specimen which is part of the collection of the Embryology Museum of the institution by donation and approved by the Research Ethics Committee (REC). The female conjoined twins were born at full-term by cesarean section in the 1970s and died hours after birth. A thorough anatomical description was made through observational analysis, computed tomography and 3D reconstructed images. Major abnormalities were observed in the cardiovascular, respiratory and digestive systems. The internal anatomy exhibited a heart with three atria, two ventricles, two aortic arches, two pulmonary arteries, one innominate venous trunk and a respiratory system with two tracheas and four lungs. No other report was similar to our three atria heart description. This article provides a thorough anatomical description of all systems, which is valuable information for further studies on CTs. [ABSTRACT FROM AUTHOR]

Pseudoephedrine (PSE) is an agent that is contained in common cold medications. The agent, which is used to treat cold and cough, is the fourth most prescribed drug group in some countries. During pregnancy, expectant mothers use PSE for colds and other reasons. One out of every four expectant mothers use PSE alone or in combination with other medicines for various reasons. This study was aimed to investigate effects of PSE on long bones development in rat during fetal growth. Pregnant rats were divided into five groups: control and four experimental groups (25 mg/kg, 50 mg/kg, 100 mg/kg, 200 mg/kg PSE). Between 1 and 20 days of pregnancy, PSE was given to them by gavage. Weights and heights of fetuses isolated by cesarean on the 21st day were measured. Ossification of femur and humerus was examined by three different methods mentioned earlier. Depending on the dose increase, all morphometric data, ossification rate and bone length of the fetuses were decreased. Besides, it was determined that the amount of Calcium in the bone tissue decreased in the analyzes made with SEM–EDX Analysis. The data obtained from this study reveal that the use of PSE during pregnancy disrupts the existing balance in the bone and negatively affects ossification due to the dose increase. In conclusion, we present descriptive and novel data on the effects of PSE use during pregnancy on the bone development of rat fetal long bones. [ABSTRACT FROM AUTHOR]

Background: Since the presence of a birth defect is often a primary outcome in drug‐safety studies among pregnant women, researching the validity of data collection methods is imperative. The aim of this study is to compare self‐reported birth defects in infants by mothers with the information provided by general practitioners (GP (singular) or GPs (plural)). Methods: Mothers who participated in the Dutch Pregnancy Drug Register reported information about possible birth defects of their infants via questionnaires. GPs were approached to provide information on possible birth defects of the same infants. All reported birth defects by mothers and GPs were blindly coded using the International Classification of Diseases, Tenth Revision (ICD‐10) index and EUROCAT‐classified as either a minor or major birth defect. Differences in reported birth defects between participants and GPs were assessed. Results: Participants and GPs (N = 551) reported 67 and 53 birth defects respectively, leading to a total of 120 birth defects among 65 infants. When both the GP and the participant reported a birth defect, 76.9% of these birth defects (N = 60) were coded with an identical ICD‐10 code. Information on the absence of a birth defect and the presence of a major birth defect was identically reported by the GP and the mother in almost all cases (98.2%). Of the major birth defects reported by the GP, 67% could be matched with information provided by the participant, for 33% contradicting information was reported. Conclusion: Self‐reported questionnaire data on infants' birth defects from mothers yield fairly similar information compared to information obtained through GPs. Future studies should validate the accuracy of self‐reported birth defects by mothers more extensively to improve the quality of drug safety studies during pregnancy. [ABSTRACT FROM AUTHOR]

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Embryofetal toxicity studies are conducted to support inclusion of women of childbearing potential in clinical trials and to support labeling for the marketed pharmaceutical product. For biopharmaceuticals, which frequently lack activity in the rodent or rabbit, the nonhuman primate is the standard model to evaluate embryofetal toxicity. These studies have become increasingly challenging to conduct due to the small number of facilities capable of performing them and a shortage of sexually mature monkeys. The low number of animals per group and the high rate of spontaneous abortion in cynomolgus monkeys further complicate interpretation of the data. Recent FDA guidance has proposed a weight of evidence (WoE) approach to support product labeling for reproductive toxicity of products intended to be used for the treatment of cancer (Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations), an approach that has also supported the approval of biotherapeutics for non-cancer indications. Considerations to determine the appropriateness and content of a WoE approach to support product labeling for embryofetal risk include known class effects in humans; findings from genetically modified animals with or without drug administration; information from surrogate compounds; literature-based assessments about the developmental role of the pharmaceutical target; and the anticipated exposure during embryofetal development. This paper summarizes the content of a session presented at the 42nd annual meeting at the American College of Toxicology, which explored the conditions under which alternative approaches may be appropriate to support product labeling for reproductive risk, and how sponsors can best justify the use of this approach. [ABSTRACT FROM AUTHOR]

The conventional view of vitamins reflects a diverse group of small molecules that facilitate critical aspects of metabolism and prevent potentially fatal deficiency syndromes. However, vitamins also contribute to the shaping and maintenance of the human phenome over lifecycle and evolutionary timescales, enabling a degree of phenotypic plasticity that operates to allow adaptive responses that are appropriate to key periods of sensitivity (i.e., epigenetic response during prenatal development within the lifecycle or as an evolved response to environmental challenge over a great many lifecycles). Individually, vitamins are important, but their effect is often based on nutrient‐nutrient (vitamin‐vitamin), nutrient‐gene (vitamin‐gene), and gene‐gene interactions, and the environmental influence of shifting geophysical cycles, as well as evolving cultural practices. These ideas will be explored within what I refer to as the "adaptive vitome (vitomics)" paradigm. [ABSTRACT FROM AUTHOR]

The American crocodile (Crocodylus acutus, Cuvier, 1807) (Class Reptilia, Family Crocodylidae) is a crocodile species inhabiting the Neotropics. Congenital defects have been described in almost every vertebrate group. In crocodiles, teratology alterations have been described in captive animals (pets, zoos, farms) such as Crocodylus niloticus or Gavialis gangeticus. The present study aimed to characterize congenital malformations of C. acutus from a farm in Lomas de Matunilla, Ballestas, Bolívar, Colombia. A total of 550 unhatched eggs were examined after embryo death. A total of 61 embryos presented malformations, with 42 different types of anomalies observed. Limb and tail malformations (29%) were the most common malformations observed. Several malformations, such as cephalothoracopagus, thoracopagus, sternopagus, xiphopagus twins, campylorrachis scoliosa, and acrania, were documented in crocodiles for the first time. Research in teratology enhances our understanding of crocodile biology. It plays a role in their conservation and management, thus helping to ensure the long-term viability of these species in their natural habitats.

Background: Information regarding the risk of early pregnancy COVID‐19 vaccination on the development of major congenital anomalies in the offspring is still limited. Here, we study the association between any COVID‐19 vaccination during the 1st trimester and at least one major non‐genetic congenital anomaly in the offspring. Methods: We used data from the Dutch Pregnancy Drug Register, an ongoing cohort study. We selected participants with a pregnancy that ended after at least 20 weeks gestation. Pregnant participants self‐reported their COVID‐19 vaccination status and the presence of congenital anomalies in the offspring. We used logistic regression analyses to study the association between 1st trimester COVID‐19 vaccination (gestational week 2 + 0 to 12 + 6) and the risk of at least one major non‐genetic congenital anomaly in the offspring. Clustering of anomalies on the ICD10 level by 1st trimester COVID‐19 vaccination status was explored using Fisher exact tests. Results: We included 3721 participants of whom 795 (21.4%) were COVID‐19 vaccinated during the 1st trimester. The percentage of participants who gave birth to a child with at least one major non‐genetic congenital anomaly was comparable between participants who were 1st trimester vaccinated (1.1%) and participants who were not (1.2%) (adjusted odd ratio 0.78 [95% confidence interval 0.35–1.71]). We found no clustering of major non‐genetic congenital anomalies by 1st trimester COVID‐19 vaccination status (p >.05). Conclusions: There were no indications of an increased risk of major non‐genetic congenital anomalies in the offspring after maternal 1st trimester COVID‐19 vaccination. Our findings suggest COVID‐19 vaccines are safe during early pregnancy. [ABSTRACT FROM AUTHOR]

Pregnancy is a frequently applied exclusion criteria for many forms of research. Common justifications for this exclusion include the potential for teratogenicity, as well as the potential for physiologic changes in pregnancy to impact the research itself. The systematic exclusion of pregnant persons from clinical studies has created a significant gap in knowledge regarding medication safety and efficacy in pregnancy, which continues to cause significant harm to pregnant persons in need of medical therapy. To produce meaningful data and facilitate effective knowledge translation to the clinical setting, special consideration to the pharmacology of pregnancy, as well as to outcomes of concern for this population is essential. The exclusion of pregnant participants from research is not ethically justifiable, as it violates the principles of autonomy, justice and nonmaleficence. While the inclusion of pregnant patients in research presents it's own challenges, with appropriate methodological, ethical, and clinical considerations, we may be able to narrow the knowledge gap and improve drug availability and safety for pregnant patients and their children. [ABSTRACT FROM AUTHOR]

This essay analyzes the medical study of "monstrous birth" as a site of race-making in the nineteenth-century United States. It argues that the medical theorization of monstrosity was structured by multiple logics of race, which both shaped and emerged from medical authorities' efforts to classify and interpret anomalous newborn bodies. Materialized at the intersection of these logics, the biological monster theorized a racial order that was hierarchical, temporalized, and vulnerable to the dangers of women's reproduction. In this context, monstrosity became a way to advance claims about the nature of racial hierarchy, articulate the threat and mechanism of racial degeneration, and negotiate the contradictions of shifting racial imaginaries across the nineteenth century. Exploring the medical engagement with monstrosity thus sheds light on entanglements of medical science and race-making in U.S. history, showing how practitioners produced and elaborated unstable concepts of scientific race, and revealing how race was linked to reproduction in the emergence of modern biomedical discourse. [ABSTRACT FROM AUTHOR]

The class Polyplacophora (chitons) represents a dorsoventrally flattened mollusk group that has an oval-shaped body covered with eight overlapping sclerites providing bilateral symmetry. Chitons show abnormalities (teratologies) that are characterized by symmetry deviations between the right and left sides of their bodies. As these deviations do not result in damage that affects vital functions, chitons are able to reach adult stages. In this study, we quantify the asymmetric condition of the species Chiton articulatus using a landmark-based geometric morphometric approach to assess variation in shape and bilateral symmetry. A geometric configuration of 22 landmarks and 50 semi-landmarks was created to evaluate shape variation in abnormal and deformed specimens compared to normal Chiton articulatus specimens. Vectors of change in the body shape configurations of chitons indicate that the greatest change occurs in the anterior part of the body, with less change in the middle and posterior parts. This gives chitons a widened appearance and provides anatomic compensation to restore the bilateral symmetry of the body scleritome. The diverse abnormalities and deformities had little impact on shape variations and confirmed that the coalescence condition is an intermediate step between a normal condition and the abnormal conditions of hypomerism or hypermerism. The low levels of fluctuating asymmetry expressed in C. articulatus indicate that despite living in areas of high stress, such as the rocky intertidal coast, this species maintains stability in its development and shape. Our results can serve as a model for studying bilateral symmetry deviation in polyplacophorans. [ABSTRACT FROM AUTHOR]

In the literature there are numerous reports of developmental deformities in arthropods collected in their natural habitat. Since such teratogenically affected individuals are found purely by chance, the causes of their defects are unknown. Numerous potential physical, mechanical, chemical, and biological teratogens have been considered and tested in the laboratory. Thermal shocks, frequently used in teratological research on the spider Eratigena atrica, have led to deformities on both the prosoma and the opisthosoma. In the 2020/2021 breeding season, by applying alternating temperatures (14 °C and 32 °C, changed every 12 h) for the first 10 days of embryonic development, we obtained 212 postembryos (out of 3,007) with the following anomalies: oligomely, heterosymely, bicephaly, schistomely, symely, polymely, complex anomalies, and others. From these we selected six spiders with defects on the prosoma and two with short appendages on the pedicel for further consideration. The latter cases seem particularly interesting because appendages do not normally develop on this body part, viewed as the first segment of the opisthosoma, and appear to represent examples of atavism. In view of the ongoing development of molecular techniques and recent research on developmental mechanisms in spiders, we believe the observed phenotypes may result, at least in part, from the erroneous suppression or expression of segmentation or appendage patterning genes. We consider "knockdown" experiments described in the literature as a means for generating hypotheses about the sources of temperature-induced body abnormalities in E. atrica. [ABSTRACT FROM AUTHOR]

Simple Summary: This study investigated congenital malformations in pigs associated with anomalous twinning. Among the conjoined twins recorded, the most common defect was syncephalus thoracopagus or cephalothoracopagus. Some dicephalic and diprosopic anomalies were also recorded. Finally, some cases of thoraco-omphalopagus piglets were studied. The pathogenetic mechanisms of this disease, which is common in veterinary practice, are discussed. The significance of embryonic conjoined twins is frequently associated with dystocia. A review of congenital malformations in swine relating to abnormal twinning was carried out. The aim was to describe and estimate these defects. Among the recorded twins, the most common defect was the syncephalus thoracopagus or cephalothoracopagus. A couple of dicephali and diprosopus congenital anomalies were also registered. At last, some cases of thoraco-omphalopagus piglets were surveyed. There was also a report of an acardiac twin (hemiacardius acephalus) and a case of a conjoined parasitic twin. The pathogenetic mechanisms of this condition, frequently reported in veterinary practice, are discussed. The importance of embryonic imperfect twinning is commonly associated with dystocia. [ABSTRACT FROM AUTHOR]

In the literature there are numerous reports of developmental deformities in arthropods collected in their natural habitat. Since such teratogenically affected individuals are found purely by chance, the causes of their defects are unknown. Numerous potential physical, mechanical, chemical, and biological teratogens have been considered and tested in the laboratory. Thermal shocks, frequently used in teratological research on the spider Eratigena atrica, have led to deformities on both the prosoma and the opisthosoma. In the 2020/2021 breeding season, by applying alternating temperatures (14 °C and 32 °C, changed every 12 h) for the first 10 days of embryonic development, we obtained 212 postembryos (out of 3,007) with the following anomalies: oligomely, heterosymely, bicephaly, schistomely, symely, polymely, complex anomalies, and others. From these we selected six spiders with defects on the prosoma and two with short appendages on the pedicel for further consideration. The latter cases seem particularly interesting because appendages do not normally develop on this body part, viewed as the first segment of the opisthosoma, and appear to represent examples of atavism. In view of the ongoing development of molecular techniques and recent research on developmental mechanisms in spiders, we believe the observed phenotypes may result, at least in part, from the erroneous suppression or expression of segmentation or appendage patterning genes. We consider “knockdown” experiments described in the literature as a means for generating hypotheses about the sources of temperature-induced body abnormalities in E. atrica.

Pleurocystitid echinoderms are known to have consistent plating in the theca or body. However, many specimens with aberrant plating are known among glyptocystitoids (Glyptocystella, Hadrocystis, Tyrridiocystis, and so on) as well as the new Ordovician species Pleurocystites? scylla, described here from the Benbolt Formation near Thorn Hill, Tennessee, USA. The presence of an extra plate in the holotype of P? scylla is most likely teratological. While teratology is often misconstrued as parasitism and pathology, it is easily recognized among glyptocystitoid rhombiferans because of the conservative nature of plate arrangements found in these taxa. Teratologic features in stemmed echinoderm thecae appear only to alter suture positioning and not significantly change the thecal shape or diminish the diagnosability of a specimen taxonomically. UUID: http://zoobank.org/287bb0b9-2df5-4b9a-b1ea-0d3cd7923826 [ABSTRACT FROM AUTHOR]

The collection of the Narrenturm in Vienna houses and maintains more than 50,000 objects including approximately 1200 teratological specimens; making it one of the biggest collections of specimens from human origin in Europe. The existence of this magnificent collection―representing an important resource for dysmorphology research, mostly awaiting contemporary diagnoses―is not widely known in the scientific community. Here, we show that the Narrenturm harbors a wealth of specimens with (exceptionally) rare congenital anomalies. These museums can be seen as physical repositories of human malformation, covering hundreds of years of dedicated collecting and preserving, thereby creating unique settings that can be used to expand our knowledge of developmental conditions that have to be preserved for future generations of scientists. [ABSTRACT FROM AUTHOR]

Background: COVID-19 vaccines are protective against disease. Pregnant women benefit from vaccination as they are at higher risk of poor maternal and neonatal outcomes following infection. Methods: Following regulatory approval of two COVID-19 vaccines in the United Kingdom, a rapid national study of vaccination in pregnancy was instituted using three existing safety surveillance platforms: UKOSS, UKTIS and VIP. This preliminary report describes the data collected up to the 15th June 2021. Results: There were 971 reports of COVID-19 vaccination in the UKOSS/UKTIS (n = 493) and VIP (n = 478) monitoring systems describing 908 individual pregnancies. Pfizer-BioNTech mRNA vaccination was most common (n = 501, 55.2%), most women were vaccinated in their second or third trimester (n = 566, 62.3%), and were mainly vaccinated due to occupational infection risk (n = 577, 63.5%). Conclusion: Obstetric outcome data will be obtained by December 2021. However, women should not delay vaccination whilst awaiting further safety data to emerge. [ABSTRACT FROM AUTHOR]

To screen the tens of thousands of chemicals for which no toxicity data currently exists, it is necessary to move from in vivo rodent models to alternative models, such as zebrafish. Here, we used dechorionated Tropical 5D wild-type zebrafish embryos to screen a 91-compound library provided by the National Toxicology Program (NTP) for developmental toxicity. This library contained 86 unique chemicals that included negative controls, flame retardants, polycyclic aromatic hydrocarbons (PAHs), drugs, industrial chemicals, and pesticides. Fish were exposed to 5 concentrations of each chemical or an equal amount of vehicle (0.5% DMSO) in embryo medium from 6 h post-fertilization (hpf) to 5 days post-fertilization (dpf). Fish were examined daily for mortality and teratogenic effects and photomotor behavior was assessed at 4 and 5 dpf. Of the 5 negative control compounds in the library, none caused mortality/teratogenesis, but two altered behavior. Chemicals provided in duplicate produced similar outcomes. Overall, 13 compounds caused mortality/teratology but not behavioral abnormalities, 24 only affected behavior, and 18 altered both endpoints, with behavior affected at concentrations that did not cause mortality/teratology (55/86 hits). Of the compounds that affected behavior, 52% caused behavioral abnormalities at either 4 or 5 dpf. Compounds within the same functional group caused different behavioral abnormalities, while similar behavioral patterns were caused by compounds from different groups. Our data suggest that behavior is a sensitive endpoint for developmental toxicity screening that integrates multiple modes of toxic action and is influenced by the age of the larval fish at the time of testing.