Hematomas caused by the rupture of a pseudoaneurysm in the middle meningeal artery (MMA) after trauma usually present as epidural hematomas. Intracerebral hemorrhage (ICH) is extremely rare. We reviewed ICH due to the rupture of MMA pseudoaneurysms. We found that in cases of acute ICH, a pseudoaneurysm was attached to the outer surface of the dura mater and associated with dura tear. In patients with acute ICH, the intraoperative rupture of a pseudoaneurysm developed just after bone flap removal. In cases of delayed ICH, pseudoaneurysms adhered to the inner surface of the dura mater. In patients with delayed ICH, the intraoperative rupture of a pseudoaneurysm developed during dura opening and hematoma removal. In situations of dura tear after trauma, the rupture of pseudoaneurysms might lead to ICH via a dura tear. Pseudoaneurysms that develop in the MMA after trauma may exert pressure and result in the thinning of the dura mater. In this case, pseudoaneurysms will adhere to the inner surface of the dura mater after several days or weeks. ICH might develop through both acute and delayed mechanisms following the development of pseudoaneurysms in the MMA. Clinicians should pay attention to the timing of such ruptures during operations for both acute and delayed ICH.  Pseudoaneurysm in the middle meningeal artery (MMA) after trauma is an uncommon entity. Pseudoaneurysms develop from the rupture of all three layers of the arterial wall. True aneurysms arise from partial damage to the arterial wall with an intact adventitia. The most common clinical manifestation of a traumatic pseudoaneurysm in the MMA is an epidural hematoma (EDH). In 1957, Schulze, reported the first case of traumatic pseudoaneurysm in the MMA presenting with an EDH ,5,6,7,8.https:scholar.google.com, accessed on 1 August 2023) were evaluated by a manual search. The references of the studies were evaluated to determine additional eligible studies that were not included during the other search. The abstracts of conference proceedings were not evaluated because of the limited information on their operative findings. A search for eligible studies was conducted in the PubMed database without restrictions on the language or publication time. The search strategy combined the terms “middle meningeal artery”, “trauma”, “injury”, “cerebral hemorrhage”, and “subdural hemorrhage” using multiple forms of medical subject heading (MESH) terms and text words. The reference lists of the eligible studies and internet sources , pseudoaneurysms in the MMA associated with arteriovenous fistula in the dura mater, and no operative treatment for MMA pseudoaneurysms were also excluded. For each study matching the inclusion criteria, the authors extracted the following data: age and sex of the patients, type of trauma, location of ICH, acute or delayed presentation of ICH after trauma, operation time from trauma, preoperative diagnostic modality of the pseudoaneurysm in the MMA, location of the pseudoaneurysm in the MMA , intraoperative rupture of the pseudoaneurysm, treatment for the pseudoaneurysm. Cases with abnormal neurological conditions upon immediate examination after trauma were classified as acute ICH. Patients with delayed deterioration after trauma were classified as delayed ICH.We evaluated 40 articles for full-text reading and excluded 28 studies after the full-text evaluation. We excluded ten articles in which they performed endovascular treatment for MMA pseudoaneurysms ,18,19,20Four articles describing acute ICH due to the rupture of a pseudoaneurysm in the MMA were included in this study. And eight studies with delayed ICH from the bleeding of a pseudoaneurysm in the MMA were evaluated in this study.The clinical data of four patients with acute ICH due to the rupture of a pseudoaneurysm in the MMA are presented in At the point where the MMA enters the cranial cavity, its histologic appearance changes to that of a cerebral artery. Defects in the media are extremely common , and theUncommonly, these may result in an SDH or ICH. However, the exact mechanism of ICH development after the rupture of an MMA pseudoaneurysm remains poorly understood.Rumbaugh et al. suggested that an SDH or ICH may result from the rupture of a pseudoaneurysm in the MMA, particularly if the dura has been torn; however, they did not present a case of dura tear resulting in ICH . Kumar eIn both reports, the authors mentioned that brisk epidural bleeding during bone flap removal and dura tear were detected. Moon et al. proposed that the rupture of a pseudoaneurysm in the MMA in contact with a dural defect could cause ICH via the dura tear . In situThe dura mater has three distinct layers. The outer layer is the thinnest layer, at 2 μm thick, whereas the inner layer is 8 μm thick and adhered to the arachnoid trabeculae. The middle vascular layer, within which the MMA runs, varies in thickness . In otheTraumatic pseudoaneurysms in the MMA are associated with temporal bone fractures, which involve the MMA groove in about 70–90% of cases . VariousRegarding ICH development from a pseudoaneurysm in the MMA, Markwalder and Huber proposed that meningeal aneurysms attaching to the inner dural surface and the cerebral cortex are the consequences of traction on a small vessel bridging the meningeal and the cerebral vascular systems . Some inAlthough the incidence is rare, the concurrence of head trauma, a skull fracture located in the temporal area, and delayed neurological deterioration suggests the presence of a MMA pseudoaneurysm. About 70% of cases of pseudoaneurysms in the MMA after trauma are associated with a fracture crossing the MMA in the temporal region . De AndrThe first extracranial segment of the MMA is from its origin to its entry into the foramen spinosum. At the level of the foramen spinosum, the artery bends anteriorly and laterally to follow the temporal fossa. After its entry into the cranial cavity, the MMA follows a lateral course grooving the greater sphenoid wing. The intracranial segment of the MMA is divided into three portions. The first is the temporobasal segment, where the artery follows the temporal fossa and curves upward, becoming the second or temporopterional segment. After passing the pterional region, the artery enters the coronal segment, where it follows the coronal suture to the end of the region of the bregma .In preoperative diagnoses, acute ICH originating from an MMA pseudoaneurysm gives rise to the suspicion of a spontaneously ruptured cerebral aneurysm, which might have caused the patient’s trauma . If acutDelayed ICH due to the bleeding of a pseudoaneurysm in the MMA develops from 3 days to 11 months after trauma ,11,39,40Pseudoaneurysms may be missed because cerebral angiography is seldom performed as a result of the introduction of CT and magnetic resonance imaging in patients after trauma. Higazi et al. reported the importance of angiography in the evaluation of pseudoaneurysms in the MMA after trauma . BozzettAoki et al. did not perform preoperative angiography before the removal of a recurrent acute SDH because of rapid progressive deterioration of the patient’s condition . During However, pseudoaneurysms are not always observed by CT angiography . It is pPouyanne et al. reported one of the most dramatic presentations of delayed ICH of a pseudoaneurysm in the MMA in 1959 ,31, we rWang et al. reported a case of an EDH only, without ICH, originating from a pseudoaneurysm in the MMA . They deAoki et al. reported extensive craniectomy, including the temporal base, after a failure to control bleeding by temporary clipping of the M1 portion during the removal of an SDH that originated from a pseudoaneurysm in the MMA . The surIn operations on acute ICH from pseudoaneurysms in the MMA, intraoperative rupture just after bone flap removal developed in two patients ,7. Moon In operations on delayed ICH from pseudoaneurysms in the MMA, intraoperative rupture from the pseudoaneurysm developed in two cases. One case developed active bleeding from the MMA after the dural opening . In thisIn our opinion, during operations for acute ICH removal, the intraoperative rupture of a pseudoaneurysm might occur just after bone flap removal because the pseudoaneurysm was attached to the outer surface of the dura mater. During surgery for delayed ICH removal, intraoperative bleeding from the pseudoaneurysm may occur after hematoma removal or dural opening because of the attachment of the pseudoaneurysm to the inner surface of the dura mater.In cases of acute ICH from the rupture of a pseudoaneurysm in the MMA ,7,8, we A partial rupture of the MMA after trauma can be repaired by clot formation, which contains intraluminal blood. Several researchers have reported pathological examination of the pseudoaneurysm in the MMA after trauma ,26,29,30More usage of CT angiography might result in the easy diagnosis of pseudoaneurysms in the MMA after trauma. Although the role of endovascular treatment for MMA pseudoaneurysms has not been well established in the neurosurgical field, endovascular embolization is a safe and effective method for eliminating re-bleeding in conditions of non-mandatory surgical decompression.In the development of a dura tear after trauma, the rupture of a pseudoaneurysm located in the epidural space produces a small EDH at the initial stage of the rupture and results in ICH in succession. In operations on acute ICH from a pseudoaneurysm in the MMA, intraoperative rupture just after bone flap removal may be developed. After the development of a pseudoaneurysm in the MMA due to trauma, pressure from the pseudoaneurysm slowly thins the dura mater until it finally attaches to the inner layer of the dura mater rather than the outer layer. In delayed ICH development due to pseudoaneurysm rupture, the intraoperative rupture of the pseudoaneurysm can be expected during both ICH removal and dural opening but not bone flap removal.In cases of acute ICH due to the rupture of a pseudoaneurysm in the MMA, the pseudoaneurysm is in contact with the outer layer of the dura mater and usually ruptures during the removal of the bone flap. In cases of delayed ICH resulting from the rupture of a pseudoaneurysm in the MMA, the pseudoaneurysm is attached to the inner layer of the dura mater and may rupture upon dura opening or hematoma removal. Surgeons should perform extensive craniotomy surrounding a pseudoaneurysm and remain aware of the intraoperative rupture of pseudoaneurysms.


This cross-sectional study examines whether perceived neighborhood safety is independently associated with adverse birth outcomes. This cross-sectional study aimed to determine whether perceived neighborhood safety is independently associated with adverse birth outcomes.Neighborhood-level exposures have found to be associated with reduced birth weight, preterm birth, small-for-gestational-age neonates, perinatal depression, and inadequate prenatal care.2 In 2016 to 2020, a question related to perceived neighborhood safety was used for respondents in Illinois, Louisiana, Minnesota, Missouri, Pennsylvania, Rhode Island, Virginia, and Wisconsin. Respondents were asked, “During the 12 months before your new baby was born, how often did you feel unsafe in the neighborhood where you lived?” Answers were categorized as always or often unsafe, sometimes unsafe, rarely unsafe, and never unsafe. Data were weighted to reflect live, singleton birth populations of 8 states. Pregnancy Risk Assessment Monitoring System data are deidentified and publicly available and institutional review board exempt; thus, informed consent was not sought, in accordance with 45 CFR §46. This study follows the STROBE reporting guidelines for cross-sectional studies.The Pregnancy Risk Assessment Monitoring System conducts surveys 2 to 4 months after delivery with linked birth certificate data.Birth outcomes analyzed included low birth weight , self-reported depressive symptoms during pregnancy or post partum, attending more than 8 prenatal care visits, attending a postpartum visit, and breastfeeding for 8 weeks or more. Multivariable logistic and Poisson regression models were used to test the independent significance of perceived neighborhood safety for the likelihood of outcomes after controlling for maternal age, race and ethnicity, marital status, educational attainment, prepregnancy insurance status, body mass index, prepregnancy smoking, preexisting gestational hypertension or diabetes, history of depression, and interpersonal physical and emotional abuse. An item, “In the 12 months before you got pregnant with your new baby, did any of the following people push, hit, slap, kick, choke, or physically hurt you in any other way?” was used to assess interpersonal physical and emotional abuse.After 1829 exclusions, 29 987 respondents were included, reflecting a weighted 8-state population of 2 172 915; 16.3% of respondents were non-Hispanic Black, 12.5% were Hispanic, 63.4% reported more than 12 years of education, 37.3% reported annual household income higher than $60 000, 23.7% had births covered by Medicaid, 35.5% reported prepregnancy abuse, 14.2% had a history of depression, 9.3% had gestational diabetes, 12.9% had hypertensive disorders of pregnancy, 18.7% reported prepregnancy smoking, and 27.3% had obesity.The majority of respondents (78.0%) reported they never felt unsafe, 13.7% responded rarely feeling unsafe, 5.3% sometimes felt unsafe, and 3.0% reported they always or often felt unsafe. A total of 6.5% of respondents had LBW neonates, 21% reported perinatal depressive symptoms, 85.9% attended more than 8 prenatal care visits, 89.5% attended a postpartum visit, and 53.9% reported breastfeeding for 8 weeks or more. Compared with respondents who never felt unsafe, those reporting always or often feeling unsafe had 23% higher odds of having a LBW neonate, 100% higher odds of perinatal depressive symptoms, and 10% lower odds of attending more than 8 prenatal care visits with no significant association with attending a postpartum visit or breastfeeding .3 Patients from communities with high levels of neighborhood violence can benefit from universal trauma-informed care, assistance with resource needs, and help in scheduling and attending appointments.4Although this cross-sectional study could not assess causation, the association of poorer perceived neighborhood safety with less prenatal care utilization is supported by a previous study from Canada.5 There are increasing calls to reduce expensive and often counterproductive police crime prevention and mass incarceration strategies.6 To more effectively support the health of pregnant people and their families, we need to invest in strengthening low-income communities, including resources for community-based violence prevention and mental health support.These findings have policy implications. Social and economic interventions designed to combat neighborhood and domestic violence may be more beneficial in reducing adverse pregnancy outcomes than biomedical interventions.


The physical environment is one of the factors that affect mother’s experience of childbirth and psychological health. A woman’s childbirth experience has been found to influence not only the mother’s own health and future births but also the well-being of her child and family. The present study’s objective was to investigate mothers’ perceptions of spatial-physical humanization, affective quality of place, and emotions during childbirth. To achieve this goal, the first part of our work was dedicated to selecting two birth environments  with different degrees of humanization. The methods include observations and field survey which mainly concerned the environmental quality of the spaces and the layout of the birth unit, and self-report questionnaire about perceived environment, affective quality attributed to place, and delivery experience. Participants are 66 low-risk women, choosing hospital or birth center. The findings indicate an enhanced perception of both the spatial-physical aspects and the social and functional aspects of the care unit among mothers who give birth at the birth center. These same mothers also report a more positive perception of the childbirth experience. In conclusion, this study contributes to the understanding of the role of birth environments in shaping mothers’ emotional experiences during childbirth. Evidence points out that positive relationships with health care providers and good healthcare-built environments play a significant role in patients’ well-being and satisfaction . SeveralSpatial-physical humanization in healthcare places focuses on meeting users’ psychological needs and recognizes the influence of environmental factors on their experiences ,6. AlthoChildbirth is one of the most challenging psychological transitions in a woman’s life, with short- and long-term consequences ,14. A reThe “humanization of birth” paradigm prioritizes the interests of mothers and babies, recognizing the influence of birth settings on women’s emotions and birth outcomes. Spatial-physical humanization might influence how women behave, their health and wellbeing, their perception of pain and how they move their bodies . Some stFurthermore, spaces that allow freedom of movement and position changes, and calming birth environment reduce stress . Women wHofberg and Brockington  coined tTraditionally, home was considered the safest place for birth, but in the 1930s, women began moving into institutional birth spaces. Calls for “humanizing birth” led to the development of birth centers, which aim to provide a more homelike environment and pain relief options . Birth cIn Italy, maternity care is guaranteed to be free of charge and is part of the National Health System (NHS), which was created in 1978 on the model of the English NHS  to ensurIn the present study, the initial stage of the methodology involved selecting two birth environments  with distinct environmental characteristics, categorized into high and low levels of humanization. The primary focus was to identify environments that varied in terms of their degree of humanization.The objective of the study was to investigate mothers’ perceptions of spatial-physical humanization, affective quality of place, and emotions during childbirth in these two environments with different environmental features .The first part of the study consisted in the selection of two birth environments with differing environmental features. Two researchers and practicing architects categorized the birth environments into high and low levels on the degree of humanization using the spatial analysis. It consisted in observations and field survey which mainly concerned the environmental quality of the spaces  and the layout of the birth unit . The spatial data collection produced both qualitative evaluation and quantitative measurements.The second part of the study is related to the measurement of women’s perception of space and emotions because of the experience of childbirth.After informed consents were obtained, midwives provided a link to fill out the questionnaire on-line, within three months of the birth, to those who have joined the research. This period was chosen because it represents in the literature a particularly delicate moment in which the woman is focused on her child and on the definition of the new identity of mother . In addiThe study was conducted after obtaining the approval of both the local hospital Ethics Committees . The data collection procedure was in line with the Research Ethical Code of the Italian Association of Psychology and the ethical recommendations of the Declaration of Helsinki, as well as the American Psychological Association (APA) standards for the treatment of human volunteers.In total, 100 women were invited from midwife, but only 66 mothers, 30 of whom were planning birth in hospital, and 36 in a birth center, accepted and completed the study. They have a mean age of 35.1 years. We select only low-risk women, whose childbirth was identified as straightforward according to local protocols of the chosen facility . Women who experienced induction, augmentation, instrumental assistance, caesarean section, epidural anesthesia or other pain relief medications were excluded. Exclusion criteria have been also considered: the lack of knowledge of the Italian language, the lack of access to means to compile online questionnaires, under 18 years of age or over 43 years, within the physiological range according to healthcare protocols for childbirth.The study was carried out in two birthplaces located in central Italy in the period between June 2018 and December 2019.This research used the online survey method for quantitative data collection.The self-report questionnaire comprised several measures:Socio-demographic information. Respondents were asked to provide some socio-demographic data .Perceived Hospital Environment Quality Indicators (PHEQIs)  . The scaScales of the Affective Quality attributed to Place (Q.A.L.) , ItalianWijma Delivery Experience Questionnaire (WDEQ-version B)  is a selCompleting the questionnaire took a mean of 20 min.The spatial analysis includes various qualitative and quantitative techniques to study the environmental property of the birth spaces. Firstly, the researchers conducted field research of the two settings consisting of collecting data by direct observations (site survey) of the built environment and taking pictures of the spaces according to the users’ activities. In addition, the floorplan of the two settings permitted to broaden the field survey with measurements of the spaces and spatial layout considerations . using tools such as Space Syntax. Both methods are fully explained in the previous article on the same research . The datWe used Jamovi Statistical Software for Social Science to compute scores on the variables of interest, perform descriptive analyses, and calculate the Cronbach’s alpha. First, Pearson’s Chi Square analyses were conducted to investigate the homogeneity of the two conditions relating to the main demographic variables. t-test to assess the presence of differences in the perception of spatial-physical humanization, affective quality of place, and emotions during childbirth between women who gave birth in a hospital and those who gave birth in a birth center. We then compared the two conditions with Student’s p-value of 0.05 or less was considered significant given the small sample size of this exploratory study.For all inferential tests, a The study was carried out in two birthplaces in two Italian teaching hospitals with significantly different spatial, physical, and social and functional aspects of the environment, reflecting a diverse level of spatial-physical humanization.The different design assumptions and aims of care of the two places are already revealed to layout level with substantial differences: the hospital has a typical triple-body configuration in which the rooms follow one another linearly; the Birth Center is an independent building and entirely dedicated to the physiological path, the layout gives the spaces a more intimate and collected conformation, with the central obstetric desk and the rooms that develop concentrically around it. These settings, with their deliberately dissimilar peculiarities, have been identified as ideal for describing settings with high and low levels on the degree of spatial-physical humanization and for exploring how environmental factors can determine similarities and differences in the affective perception of a place of birth by women. The Hospital setting is representative of a typical Italian labor and maternity ward, whereas the Birth Center Unit was selected between three Italian-recognized Birth Centers for its innovativeness; it is the only one designed and realized specifically as Birth Center. Case 1—Hospital setting  The Case 1 setting provides care to high and low-risk women thanks to a team of midwives and doctors. In this setting, mothers don’t spend their entire stay in the hospital’s Labor, Delivery, and Recovery (LDR) rooms, because they are moved into a separate postpartum area following the birth. The labor and birth ward, situated on the hospital’s second floor, is a typical hospital ward, with pillars imposing a rectangular layout where the rooms overlook a long corridor where the main flows are concentrated . The sta2 comprehending the en-suite bathroom. A resuscitation room is in common for every two rooms. The rooms, quite spacious, have as the focus the bed, around which all the equipment is organized, except for those two which have a birthing pool inside. The rooms are bright thanks to a big window overlooking the outside , and the warm colors of the cream-colored floor and walls, white and pale yellow, with orange doors. The feeling provided by the room is to be in a hospital due to the medical equipment on sight, the hospital bed, and the type of furnishing. The sense of privacy is not highly guaranteed since the door opens directly to the main corridor where all the main activities happen, and the users walk.The six rectangular LDR rooms measure around 25 mCase 2—Birth Centre setting  The Case 2 setting, the alongside midwife-led unit, run by a team of midwives, provides care to women with straightforward pregnancies who decide to give birth physiologically. In this setting, mothers usually spend their entire stay since the midwives are responsible for ante, intra, and postpartum care: after birth, they have the possibility to stay in their Labor, Delivery, Recovery, and Postpartum (LDRP) rooms for the other 48 h. 2 comprehending the en-suite bathroom (without shower) and present as the focus of the room a colored birthing pool, followed by a home-like double bed and various furnishings that foster physiologic birth and emergency equipment hidden within the furniture. The LDRP rooms are not particularly bright because the windows are positioned at the top of the wall, while the central area housing the midwives’ desk and the corridor outside are bright; the latter also enjoys a view of the green. The atmosphere is welcoming and domestic due to the particular furniture. In addition, medical equipment is present but hidden within the furniture. The sense of privacy is guaranteed as the LDRP room has two access possibilities: a more lateral one that faces the corridor and can be closed if necessary, and a more central one that connects directly with the midwives’ desk.The Unit is located on the first floor of a two-floor independent building that has a round plan and thanks to a short corridor is directly linked to another building dedicated to Maternity care, so in case of need or emergency women and/or babies can be rapidly connected to the Obstetric-Led Unit, Neonatal Unit and Caesarean Section theater. The layout of the Unit is unusual for a healthcare setting: it is based on a circular system organized radially around a central space, where the midwives’ workstation is located . Around The mothers included in the study have an average age of 34.13 years in the hospital context and of 33.94 years for those who give birth at the birth center. We have a 53.3% primiparous in the hospital context, while 50% of those who are admitted to the Birth Center declare to be at the first pregnancy. In both contexts almost all of the participants declare themselves married . Thirty percent of participants have a university degree in hospital (33.3%) and in birth center (30.6%) and in most of the respondents  were employed, followed by a small group of housewives . Unemployed people represented 5.6% of the total respondents in birth center. Chi-Square analysis revealed that the two groups are homogenous in all demographics.Statistical processing produced a total of 9 indicators of Perceived Hospital Environment Quality . Most diAs presented in All dimensions exhibit excellent internal consistency with Cronbach’s Alpha above 0.80, except for the View dimension, which has an Alpha above 0.60, and the Privacy dimension, which has a Cronbach’s alpha of 0.45.In the hospital context, the highest averages are related to Privacy (m = 4.52) and Building aesthetics (m = 4.04), while the least humanized dimensions result in Views (m = 2.22) and Care for waiting or meeting rooms (m = 2.37). In the Birth Center, the highest averages are relative to Privacy (m = 4.81) and Availability and Professionalism of operators (m = 4.80), while the dimension less humanized turns out to be Views (m = 2.66) and Climatic comfort (m = 3.65). The Student T test for independent samples was conducted on the two groups  and showp < 0.005). Spatial analysis has shown that the condition and quality of furnishing in Hospital are good, and coherent with a hospitalized setting hosting recent equipment and furnishing; walls, floors, and ceilings are well maintained and clean (Building aesthetics have a more positive assessment in the Birth Centre setting (t(64) = 3.35, nd clean . Howevernd clean .t-test value was t(64) = 3.09 with a p-value of p < 0.005, indicating a statistically significant difference in the perception, with a higher mean in the Birth Center. Direct observations of the built environment reveal that inside the Hospital, acoustic comfort is not completely guaranteed in the rooms because it may happen that the quietness is disturbed by the noise coming from the outside, being the rooms facing the unique long corridors where all the flaws pass through. On the contrary, in the Birth Center, the layout promotes better acoustic comfort because the presence of two doors permits better screening of the noise and creates a calmer working station to which doors open.In the dimension Acoustic comfort the p < 0.000), this is coherent with spatial analysis that highlights that they are insufficient for the purposes of the Unit. The staff has a little space to rest and eat but could be better equipped both as a kitchen and as a resting area; external visitors don’t have waiting or lounge rooms, so they are forced to wait/have a snack outside the unit or inside the hospital rooms where no specific space is dedicated to them. In the birth center, there are various waiting areas for partners or supporters, who have the possibility to wait and socialize in the outer corridor where seats are specifically located for them, including an area for kids, or use the little kitchen or enter the LDRP rooms where is also offered the possibility to spend the night in the double bed. Perception about care for waiting or meeting rooms is significantly lower in Hospital (t(64) = 9.65, p < 0.000) is in line with spatial observations that reveal that in the hospital the orientation is great, the layout has a functional and standard design that creates simple wayfinding, allowing visitors to presume the logic in orientation, but the highly repetitive and squared spaces don’t easily indicate the position of information points, only insufficient signposting allows them to find what they are looking for  = 3.74, king for . The unit-test shows a significant difference between the two groups in the perception of organization clarity (t(64) = 4.76, p < 0.000). The spatial organization of the hospital unit, rigid and standardized, is not immediately reflected in an organization clarity where patients can identify the name and function of the staff members or whom to ask for information, in fact, the staff workstation is not on sight and is not clear where they could be or where to wait for them, adding the fact that other healthcare professionals may pass through the corridor, directed in another care unit. The p < 0.05). In the hospital layout, the unit imposes that the door of the LDR opens to the corridor where could pass staff members, visitors, or other pregnant women, but can prevent the sensation of mothers being watched since doors are usually closed and the unit is not often too crowded. In the birth center, it is possible to notice that mothers may perceive a higher sense of privacy thanks to the fact that the setting is generally less crowded than the unit because there are no staff or visitors passing through, and that the two doors prevent the sensations of being watched from ‘strangers’ since the inner door, used by midwives and likely more open, face to a working area, where there are usually no visitors.Privacy has high scores in both settings, however, there is a significantly more positive perception in the birth center (t(64) = 2.11, p < 0.000). In the hospital the availability of operators is not favored by the configuration of the Unit because the staff members don’t have complete control of the visitor flow, since their workstation is located in those rooms on side of the long corridor, so they are not facilitated in providing a nice welcoming to visitors or create a good cooperative atmosphere with visitors since they don’t share a pleasant or relaxing space in which to share comments or have a conversation. On the other hand, the spatial analysis conducted on the birth center reveals that staff is supported by the configuration of the unit because they operate in the more integrated area of the unit; from the working station midwives easily control the birth rooms and the entrance flows which facilitate a nice welcome. In addition, a shared kitchen, and a restroom next to a unique working station favor a good cooperative atmosphere among staff members which has easier and more immediate communication thanks to the layout.Finally, the dimension Availability and professionalism of operators has been evaluated more positively by mothers that gave birth in the birth center (t(64) = 4.85, In two dimensions there are no differences in the perception of the two groups: climate comfort and View. This appears quite in relation to the spatial characteristics detected by the observational measurements of the two settings. In fact, good climate comfort is guaranteed in both settings , even if the big windows of the hospital unit may permit a greater air exchange from the outside and suitable air humidity in all the rooms, except for the long corridor. Concerning the views, the windows of the LDR rooms provide views of the outside; green spaces are not visible, but the view has anyway little interest, especially for the sunlight provided. Conversely, the birth room of the second setting doesn’t allow any view to the outside, except those permitted to the skylight, because the windows are at a high level, not at eye level, so it is not possible to benefit from the view of green spaces which is instead possible from the big windows of the external corridor. In both groups, social and functional indicators achieve higher scores than spatial physical ones, highlighting a greater impact of these elements on the perception of spatial-physical humanization of the context.t-test yielded a significant difference (t(64) = 7.07, p < 0.001) between the two settings, indicating that the hospital context elicited significantly lower perceptions of relaxation compared to the birth centre. Regarding the dimension Pleasant, the mean score was 31.36 (SD = 4.45) in the birth centre and 19.37 (SD = 8.67) in the hospital context. The t-test showed a highly significant difference (t(64) = 7.24, p < 0.001) between the two settings, suggesting that the birth centre was perceived as significantly more pleasant than the hospital context. For the emotional descriptor Exciting, the mean score was 22.05 (SD = 7.57) in the birth centre and 14.63 (SD = 9.34) in the hospital context. The t-test revealed a significant difference (t(64) = 3.49, p = 0.001) between the two settings, indicating that the birth centre was associated with higher perceptions of excitement compared to the hospital context. Regarding the emotional characteristic Challenging, the mean score was 15.19 (SD = 5.53) in the birth centre and 16.50 (SD = 6.81656) in the hospital context. The t-test did not yield a statistically significant difference (t(64) = 0.403, p > 0.05) between the two settings for this affective quality of the place.As regards the affective quality of the place  for the t-test showed a highly significant difference (t(64) = −6.52, p < 0.001) between the two settings, indicating that the hospital context was perceived as significantly more stressful than the birth centre. Regarding the emotion label Unpleasant, the mean score was 0.72 (SD = 1.36) in the birth centre and 7.53 (SD = 7.37) in the hospital context. The t-test revealed a highly significant difference (t(64) = −5.438, p < 0.001) between the two settings, suggesting that the hospital context was associated with significantly higher perceptions of unpleasantness compared to the birth centre. For the emotional descriptor Depressing, the mean score was 1.14 (SD = 1.89) in the birth centre and 6.03 (SD = 7.07) in the hospital context. Also for this adjective the t-test showed a highly significant difference (t(64) = −3.988, p < 0.001) between the two settings, indicating that the hospital context elicited significantly higher perceptions of depression compared to the birth centre. Finally, for the adjective Boring, the mean score was 1.97 (SD = 4.07) in the birth centre and 6.73 (SD = 7.02) in the hospital context. The t-test revealed a significant difference (t(64) = −3.439, p = 0.001) between the two settings, suggesting that the hospital context was perceived as significantly more boring than the birth center. For the adjective Stressful the mean score was 1.03 (SD = 1.83) in the birth centre and 10.23 (SD = 8.25) in the hospital context. The p < 0.001). In addition, the average score in the hospital context was 96.17 (SD = 16.29) and exceeds the threshold value of 85, considered critical in the literature, while in the Birth Center the average score is 74.89 (SD = 20.34). Compared to the overall score of the Wijma Delivery Experience Questionnaire scale, there is a statistically significant difference between the two contexts (t(64) = −4.62; In t-test revealed a significant difference (t(64) = −3.50, p < 0.001) between the two settings, indicating that the hospital context was associated with significantly higher perceptions of a lack of self-efficacy compared to the birth center. Regarding the subdimension Loneliness, the mean score was 15.22 (SD = 5.98) in the birth center and 21.53 (SD = 5.21) in the hospital context. The t-test yielded a highly significant difference (t(64) = −4.52, p < 0.001) between the two settings, suggesting that the hospital context elicited significantly higher feelings of loneliness compared to the birth center. For the Negative Appraisal the mean score was 10.56 (SD = 4.10) in the birth center and 12.17 (SD = 3.51) in the hospital context. The t-test did not show a statistically significant difference (t(64) = −1.99, p = 0.095), between the two settings for this subdimension. Regarding the Lack of Positive Anticipation, the mean score was 8.25 (SD = 3.07) in the birth center and 10.83 (SD = 3.14) in the hospital context. The t-test revealed a significant difference (t(64) = −3.37, p = 0.001) between the two settings, indicating that the hospital context was associated with significantly lower levels of positive expectations compared to the birth center. For the dimension Fear, the mean score was 12.42 (SD = 3.74) in the birth center and 16.10 (SD = 3.56) in the hospital context. The t-test showed a highly significant difference (t(64) = −4.07, p < 0.001) between the two settings, suggesting that the hospital context was associated with significantly higher levels of fear compared to the birth center. Finally, regarding the Concern for the Baby, the mean score was 3.00 (SD = 1.60) in the birth center and 4.37 (SD = 2.30) in the hospital context. The t-test revealed a significant difference (t(64) = −2.84, p = 0.006) between the two settings, indicating that the hospital context was associated with significantly higher levels of concern for the baby compared to the birth center.As presented in Overall, the findings indicate that for the subdimensions of the delivery experience, women in birth center showed significantly lower means in Low self-efficacy, Loneliness, Negative appraisal, Lack of positive anticipation, Fear, and concern for the baby compared with women in hospital.Researchers know that childbirth represents a major life event in women and family life. Childbirth experiences are subjective psychological and physiological processes, influenced by social and environmental factors. In the context of childbirth, spatial-physical humanization involves creating a comfortable and supportive environment that empowers women, increasing the wellbeing. However, literature highlights the limited knowledge on how birth environments may affect the health of birthing women  and the The objective of the current research was to contribute to reflection on birth environmental role on mother emotional experience of childbirth. In the first part of the study, hospital and birth center, identified as ideal for exploring how environmental factors can determine similarities and differences in the affective perception of a place of birth by women, were analyzed and categorized into high and low levels on the degree of humanization using the spatial analysis. The presentation of the two case studies underlines how different spatial, physical design, and social and functional attributes are associated to different levels of spatial-physical humanization and their relationship with wellbeing. In this regard, recently, Cho  investigPresent study findings support the hypothesis that the different degree of objective physical-spatial humanization of the environment dedicated to labor and childbirth is reflected in the perception of users, both regarding the physical-spatial, and socio-organizational aspects that characterize the setting. From this comparison it emerges, in line with the studies of Fourier and Herter , how theBoth settings are perceived with a positive affective quality, the “relaxing” and “pleasant” dimensions have higher scores than the opposite “stressful” and “unpleasant”; however, the birth center is perceived significantly more positively from an affective point of view by mothers. Specific locations and settings, like the childbirth setting, may acquire some form of special meaning for people. Affective evaluations could be very much ‘place centered’  and coulIn a previous work  some autRegarding the delivery experience, mothers who give birth in the birth center perceive the experience less negatively than those who give birth in the hospital in terms of fear, loneliness, low self-esteem, concern for the child. This work represents a first exploration of the importance of physical-spatial humanization in promoting well-being during a delicate time in the life of women and the family as childbirth. By prioritizing the individual’s physical and emotional well-being, spatial-physical humanization can help create a safe and supportive environment for delivery. Future studies could explore how spatial-physical humanization can promote a sense of trust and connection between the woman and care providers, and how this can further reduce fear and anxiety. Recent work analyzes the impact of differently designed birthing rooms at a hospital-based labor ward , our stuThere are several limitations in this study. First of all, the small number of participants does not allow us to generalize our observations to other contexts, however it is important to remember that childbirth, and the period after childbirth, are delicate moments in the life of the woman and the family and that it can therefore be very difficult to reach the participants. Secondly, due to the correlative nature of the research design, it is not possible to prove the existence of causal relationships between perceived spatial-physical humanization, affective quality of place and mothers’ emotions towards birth.Third, our results on the better perception of childbirth event in BC than in hospital can be considered associated with the mothers’ choice to give birth in this peculiar space . This chFinally, it is important to note that the data were collected before the COVID-19 Pandemic, which had a significant impact both on the well-being of new mothers  and on tThe study broadens the knowledge about the mothers’ perception of the birth physical environment and develops maternity spaces design knowledge. The findings highlight the importance of spatial-physical humanization in creating a supportive and empowering environment for women. The birth center, characterized by higher levels of spatial-physical humanization, was perceived more positively by mothers compared to the hospital setting. These perceptions were reflected in affective evaluations, with the birth center being associated with feelings of relaxation and pleasure. Furthermore, mothers who gave birth in the birth center reported a less negative delivery experience in terms of fear, loneliness, low self-esteem, and concern for the child. The study underscores the importance of considering the subjective experiences and perceptions of women when designing birth environments. Affective evaluations of the environment play a crucial role in shaping the overall childbirth experience. Our study gives valuable insight into environmental variables associated with women emotions in childbirth experience thanks to the encounter between the disciplines of architecture and design and environmental and perinatal psychology. Multidisciplinary has made it possible to integrate different perspectives that allow a better understanding of the relationship between spatial elements and emotional well-being. Furthermore, our study could have implications for the design of the birth environments and health-care policy, supporting birth centers. In conclusion, by prioritizing physical and emotional well-being, spatial-physical humanization can contribute to a better childbirth experience.


Ex Vivo Lung Perfusion (EVLP) can be potentially used to manipulate organs and to achieve a proper reconditioning process. During EVLP pro-inflammatory cytokines have been shown to accumulate in perfusate over time and their production is correlated with poor outcomes of the graft. Aim of the present study is to investigate the feasibility and safety of cytokine adsorption during EVLP. From July 2011 to March 2020, 54 EVLP procedures have been carried out, 21 grafts treated with an adsorption system and 33 without. Comparing the grafts perfused during EVLP with or without cytokine adsorption, the use of a filter significantly decreased the levels of IL10 and GCSFat the end of the procedure. Among the 38 transplanted patients, the adsorption group experienced a significant decreased IL6, IL10, MCP1 and GCSF concentrations and deltas compared to the no-adsorption group, with a lower in-hospital mortality (p = 0.03) and 1-year death rate (p = 0.01). This interventional study is the first human experience suggesting the safety and efficacy of a porous polymer beads adsorption device in reducing the level of inflammatory mediators during EVLP. Clinical impact of cytokines reduction during EVLP must be evaluated in further studies.  Lung transplantation (LTx) is a well-established therapy for selected patients with various forms of end stage, progressive lung disease. Since the first lung transplant in 1963, the field of LTx has advanced in the selection of candidates, operative techniques, critical care management, immunosuppression, and long-term follow-up. During the last 10 years a significant increase of lung transplant procedures has been recorded if compared with other organs . HoweverEx Vivo Lung Perfusion (EVLP) techniques. The ideal donor characteristics are the followings: age <55 years, with a smoking history <20 pack-year, no chest trauma, clear chest X-ray, PaO2/FiO2 (P/F) ratio >300 and absence of purulent secretions at bronchoscopy , and needed more frequently post-transplant VV-ECMO [8 (36%) vs. 4 (25%) pts]. The patients included in the no-CytoSorb® group showed a higher in-hospital mortality  and 1-year death   the EVLP remains useless to rehabilitate marginal or initially rejected grafts regardless the use of Cytosorb®. In these situations, the inflammatory cascade is maintained during perfusion and the cytokines removal may not be effective due to the continue production and release of inflammatory products. Moreover, the duration of EVLP is clinically driven and it is based on clinical parameters  collected during the perfusion suggesting the utility or futility of the EVLP. This creates a different length of duration of the treatment. As a matter of fact, median duration of EVLP was 4 (IQR 3–4) and 5 (IQR 4–6) hours in the rejected and transplanted groups, respectively (p < 0.01) and IL6 concentrations higher in the rejected grafts in comparison with transplanted grafts . This means that, based on clinical evaluation, the rejected grafts are more “inflamed” and less responsive to EVLP with or without Cytosorb® and the reconditioning therapy is shorter because the futility of EVLP becomes evident earlier. Conversely, the transplanted group is more homogenous for the duration of EVLP and cytokines concentrations at the beginning of perfusion. In this cohort the effect of cytokines’ absorption can be more visible: same T0 concentration or even worse level in the Cytosorb® group, same duration of treatment, less cytokines concentration at the end of the perfusion and lower deltas.In overall perfusions, despite a significant lower concentration of cytokines at the end of EVLP in the grafts perfused with Cytosorb® in the clinical setting of lung transplantation and this represents the first experience reported in man so far.The main finding of our initial clinical series is that the reduction of the level of inflammatory mediators can be effectively achieved using a porous polymer beads adsorption during EVLP with the use of CytoSorb®.As a matter of fact, the impact of cytokines removal during EVLP has been investigated in the animal model only, both on normal or injured grafts and never in man. In 2010 the Japanese group of Kakishita and coworkers  tested f® acts as a not selective filtering membrane according to the dimensions of molecules and porous beads. Mechanical removal depends on concentration and molecular weight (up to 50 KDa) of the mediators, therefore both inflammatory and anti-inflammatory cytokines are removed. It can be speculated that however, the removal of pro-inflammatory mediators overcomes the potential negative impact of anti-inflammatory cytokines removal. Moreover, the role of the ratio between pro and anti-inflammatory mediators could be investigated. From a methodological perspective, our results come from a no-randomized retrospective series and potentially confounding factors may jeopardize our clinical findings. Many factors (both related to donor and recipient) during all the phases of transplant  may interact each other in the definitive decision-making process. Moreover, the two groups refer to a different “historical” period: the no-CytoSorb® cohort refers also to the very beginning of EVLP program with an intrinsic learning curve phase in terms of indication, management and assessment of grafts treated with EVLP. It should be noticed that the two cohorts of transplanted patients are similar but with some statistically significant differences. For example, the need of CPB was higher in the no-CytoSorb® group even if the no-CytoSorb® recipients were younger and receiving more frequently a bilateral transplant (the latter are well-known positive prognostic factors). Regarding recipients’ characteristics no-CytoSorb® group received a graft from donors with a longer mechanical ventilation time although this statistical difference seems insignificant from a clinical point of view (3 vs. 4 days). Finally, the relatively small sample size does not allow a deeper statistical analysis reducing the possibility to draw robust conclusions. However, our first aim was only to evaluate the safety and efficacy of cytokines reduction in the clinical setting. Considering the mean values of cytokines levels  at Tf between the Cytosorb® and no-Cytosorb® groups, their standard deviation and the total sample size, with an alpha error of 0.05, our study power is ≥0.95. The power of the mean difference between base 10 logarithm of IL-6, IL-10 and GCSF levels at Tf and T0 in the transplanted population between the Cytosorb® and no Cytosorb® groups, considering their standard deviation and the total sample size, with an alpha error of 0.05 is ≥0.93 and 0.45 for MCP1.Our study suffers from both conceptual and methodological limitations. CytoSorbThe clinical impact of cytokines adsorption must be further validated in more rigorous, prospective, randomized clinical trials. However, our analysis refers to a consecutive lung transplant series in a medium-volume center and it can be considered a representative picture of daily clinical practice given the limited number of lung transplants and even fewer procedures of EVLP run worldwide. Clinical scenario of lung transplantation is changing and graft perfusion techniques play an important role.EVLP not only represents a reliable platform to evaluate and preserve graft before transplant but it can be potentially used to manipulate organs and to achieve a proper reconditioning process. Inflammatory response has been shown to have a central role on graft function after transplant and an active treatment using removal strategies of cytokines during perfusion is very attractive.


A laryngeal cyst is usually benign. The most common site origin of a cyst in the larynx is the lingual surface of the epiglottis. Epiglottic cysts are rare. Usually, it is asymptomatic in patients and can be treated conservatively if the size is small. Airway obstruction is very rare but could be life-threatening. If there is airway obstruction, the cyst should be removed immediately. Early detection and immediate management lead to favorable outcomes. A multidisciplinary-team approach with the ENT and anesthetic inputs are essential when dealing with the current condition. This case report highlights the management of such a patient who presented with airway obstruction due to an epiglottic cyst. Epiglottic cysts are benign and usually occur on the lingual surface of the epiglottis. The occurrence is very rare and normally discovered in patients during acute infection. Usually, it is asymptomatic in patients, and epiglottic cysts have been treated conservatively if the size is small. Tuang et al. stated in an infant, they may cause sudden death, but in adults, they appear as a lumpy sensation and the clinician might miss it. They are mostly asymptomatic but if the size is large, it may obstruct the airway and can result in upper airway obstruction. If there is any sign of airway obstruction, the cyst should be removed immediately. Once the cyst is detected, it can be managed via endoscopic resection or marsupialization. Immediate management is preferred. A multidisciplinary-team approach between the anesthetic and ENT team will bring a great approach to treating patients with this condition -3. Here We would like to present a case of a 40-year-old gentleman, a heavy smoker, who presented to the emergency department with a foreign body sensation in the throat for six months but worsening in symptoms for three weeks. The patient experienced intermittent shortness of breath lying flat, and often have to bend down to make himself relieve of the symptom. Otherwise, there was no history of stridor, dysphagia, tachypnea, or hoarseness. The patient was comfortable with an oxygen saturation of 98% to 100% under room air. On examination, there were no palpable neck masses, and the oral cavity was normal with no trismus. Flexible endoscopy revealed a round pedunculated mass arising from the left epiglottis obstructing the whole airway Figure . A huge The etiology of the epiglottis cyst still remains unknown. It commonly arises from the lingual surface of the epiglottic region. De Santo et al. divided laryngeal cysts into ductal and saccular types based on histological components. Based on our histopathological findings of the left epiglottic cyst, it was revealed as a ductal cyst. A newer system by Forte, et al, classifies the laryngeal cyst based on the extent and embryologic tissue of origin. In pediatrics, common presentation is stridor and respiratory distress, and adults usually present with foreign body sensation in the throat, and hoarseness, which seldom leads to respiratory distress. Common presentations in an adult will be a muffled voice, dysphagia, odynophagia, and biphasic stridor but there was no such presentation in our patient -3.Normally, a lateral x-ray of the neck shows a soft tissue shadow around the epiglottic area and computed tomography would be the imaging of choice and useful tool for immediate confirmation of the diagnosis. In our patient, awake fiberoptic intubation was attempted because it is the gold standard for any difficult intraoral, and the patient was not exposed to induction agents and muscle relaxants. The advantage of awake fiberoptic intubation will prevent the patient to avoid post induction CICO  situation. Besides, awake fiberoptic is performed because the upper airway can be examined before induction of the anesthesia which is helpful for diagnostic purposes and to predict how difficult the intubation would be . HoweverTreatment of epiglottic cysts depends on their size and severity of airway obstruction. Patients with an asymptomatic epiglottic cysts can be observed, larger cysts require surgery. One of them is marsuplisation or endoscopic excision of cysts. A few cases reported performing carbon dioxide laser during endoscopic surgery has been effective due to its good hemostatic effect ,5.Besides, the cyst can be aspirated via a long needle to reduce the size of the cyst using a 22-Gauge spinal needle which enables the cyst to shrink and enables the anesthesiology team to intubate using the Macintosh laryngoscope which is a safer way to avoid unnecessary tracheostomy. In some cases, the lateral pharyngectomy method is used especially in recurrent cases. In our case, despite the administration of muscle relaxation drugs, the patient was still not cooperative because he was having difficulty breathing due to an epiglottic cyst that totally obstructed the airway causing the patient to be more restless. However, manipulation of the larynx made, by lying side to side but failed. Using blades such as Miller blade or McCoy carries the risk of rupture of the cyst where the patient can have laryngospasm if there is any spillage of the cyst into the trachea which leads to cardiac arrest in the worst-case scenario and we proceeded with tracheostomy under local anesthesia. After the tracheostomy, the patient was commenced under general anesthesia, and marsuplization of the cyst was done via direct laryngoscopy. Studies show that supraglottic airway devices are useful, but it also has the risk of rupture ,6.Moreover, we can also use the curved or bend-needle trans-orally with the guidance of the flexible nasolaryngophayrngoscope to aspirate the cyst. By performing this, the size of the epiglottic cyst gets smaller and is able to relieve the airway till OT calls and to ease the intubation. This can be done in clinical settings and when the patient is awake. The patient will be sitting upright position where lidocaine 2% about 1 to 2 mL injected via scope and flushed to the laryngeal inlet. The patient will cough and subsequently patient will feel numbness over the laryngeal region and chances of bleeding, hematoma, and aspiration which limits access. In our case, the epiglottic cyst is pedunculated and obscuring the airway, and the patient was in impending airway obstruction with intermittent shortness of breath. We anticipated the risk of aspiration of cystic content into the airway which can cause irritation and further compromise the airway. The best way is to perform aspiration in a controlled setting with the anesthetic team -9.An epiglottic cyst can be one of the causes of airway obstruction. Treatment of epiglottic cysts depends on the size and severity of airway obstruction. Patients with an asymptomatic epiglottic cyst can be observed, larger cysts require surgery. Early diagnosis can avoid unnecessary tracheostomy. Maintaining the airway and preventing the rupture of cysts play a crucial role in the airway management of epiglottic cysts.


The World Health Organization recommends birth companionship for all women in labor. There is insufficient evidence on birth companionship in low-income settings and it is not clear if role orientation impacts effectiveness. The aim of this study was to assess the efficacy of midwife-led role orientation of birth companions of on maternal satisfaction and birth outcomes in a sub-region in Uganda.n = 240), intervention n = 235) from 4 clusters. Women who had a birth companion, in spontaneously established labor and, expecting a vaginal delivery were eligible. The intervention was “midwife-provided orientation of birth companions”. The admitting midwife provided an orientation session for the birth companion on supportive labor techniques. The primary outcome was the chance of having a spontaneous vaginal delivery. Assessors were not blinded. Independent t-test and Chi-Square tests were used to assess the differences by study period.A stepped wedge cluster randomized trial conducted (control P > 0.001). High maternal satisfaction levels were noted among the women who were; at the regional referral hospital, younger, first-time mothers, and unmarried (P < 0.001). Satisfaction with pain management was rated lowest across study periods. Satisfaction with humaneness was rated highest with a higher score in the intervention period (93%) than the control (79.5%). There were no statistically significant differences in the mode of delivery, need to augment labor, length of labor and Apgar scores.Mean maternal satisfaction rate was significantly higher in the intervention period compared to the control period (Midwife-led role orientation of birth companions increased maternal satisfaction. Nevertheless, no significant effect was noted in the mode of delivery, length of labor, Apgar score, and need to augment labor. Findings could inform the integration of birth companions in the admission process of the woman in labor in similar settings.NCT04771325. There has been progress in the maternal and neonatal mortality rates in Uganda. This has been mainly attributed to skilled birth attendance . PromotiThe World Health Organization (WHO) recommends that every woman be supported continuously throughout labor by a companion of choice to promote a positive childbirth experience , 6. ContSeveral barriers have been identified in the implementation of the presence of a companion of choice at birth in resource strained hospital settings. Amongst these is the absence of clear communication with the companion about their role . WHO recThere is a deficit of evidence on the effect of continuous labor support in low-income settings. Also, it is still unknown if training improves the effectiveness of continuous labor support . TraininThe study was carried out in the Bugisu sub-region located in the Eastern part of Uganda. The Bugisu sub-region consists of six districts, including Manafwa, Mbale, Bududa, Sironko, Namisindwa, and Bulambuli. According to the Uganda National Bureau of Statistics, the sub-region is home mainly to the Gisu people with an average household size of 4.8 and a literacy rate of 51.5% . The subA cross-sectional stepped wedge cluster randomized trial was used. In this design, different individuals in the control and intervention are used with a single observation of outcomes . This apWomen who had a birth companion, in spontaneously established labor and expecting a vaginal delivery were included. Exclusion criteria were women with multiple pregnancies, previous cesarean section, with mental illness, deaf or mute .The intervention was “midwife-provided orientation of birth companions”. After labor was confirmed, in addition to the routine admission procedure, the midwife explained to the birth companion the different support techniques and clarified what was expected of them. We assumed that providing an orientation session was likely to boost birth companion confidence, hence increasing the effectiveness of continuous labor support. The content for the orientation session consisted of providing emotional and physical support. Emotional support included being present, demonstrating a caring and positive attitude, saying calming verbal expressions, using humor, and praise, and encouraging and acknowledging efforts. Physical support included supporting her to change positions favoring upright positions, walking with her, giving her drinks and food, massaging, reminding her to go and pass urine, helping her find a comfortable position for pushing, and wiping her face with a cool cloth. The content was developed based on the literature on labor companionship techniques. The orientation sessions were headed by four registered and licensed midwives. These directed and supervised the admitting midwives in the four respective clusters on the orientation of birth companions on labor supportive techniques. The first author EWW trained these midwives on how to conduct these sessions. Orientation was conducted face-to-face, individually for the birth companion. This orientation was integrated into the admission procedure for the woman and lasted about 20 min. Each task was explained in simple terms, including why the task was important and how it was performed, then companions were shown how it was performed, with return demonstrations from the companion. This was repeated for the birth companion to grasp and retain the task .Women are escorted to the health facilities by one or more family members or friends. One person is allowed besides her to provide support. The support persons do not receive any orientation sessions and have no designated roles. Information is provided on the need arise basis. That is; when the midwife needs anything in particular or help from the birth companion. Routine analgesia is not given. Midwives, medical officers, and obstetricians provide skilled care. Typically, two to three midwives are allocated per 8-h shift managing about six laboring women at a given time.https://doi.org/10.3390/ijerph20021549.The primary outcome was the chance of having a spontaneous vaginal delivery. The secondary outcomes were; the incidence of having a spontaneous vaginal delivery, length of labor, Apgar score, coping, anxiety and maternal satisfaction. Maternal anxiety and coping during labor are reported in another article and can be accessed at Sample size and randomization: The sample size for this trial was calculated based on the primary outcome . The baseline rate for having a spontaneous delivery was 87%. We assumed that guiding birth companions on continuous labor support contributed to a 10% difference . We set Alpha at 95% CI (0.05 = 1.96), β multiplier for 80% at 0.842. A sample size of 290 participants per period was calculated. The number of study participants was selected proportionately; that is, according to the patient volumes of the particular facilities. Approximately 12,500 women delivered during the study period including the 6 months break of the COVID-19 lockdown  and Apgar score. Maternal Satisfaction was assessed using a questionnaire; this questionnaire was developed basing on literature on maternal satisfaction with intrapartum care [Data were collected from the woman’s labor clinical notes using a data abstraction form. The first part entailed the woman’s socio-demographic information and obstetrical information including; parity, weeks of gestation, status of membranes on admission and birth weight. The second part contained the time of admission and cervical dilation on admission, time of delivery, duration of 1tum care –22. It htum care .P value. For the binary outcomes the percentages and frequencies were presented for each group; including the odds ratio and p-values. A P-value of < 0.05 was taken to be statistically significant. Subgroup analysis was also done to evaluate treatment effects for specific end point groups [Data was entered using excel and imported to STATA 14 for analysis . Birth ot groups . MultivaThe majority of the respondents were in the age group of 15–24 years. Most of the respondents were first time mothers (44.7%). A majority were first time mothers (43.6%). All women had at least attended primary school and only 7.8% had a tertiary education. Forty percent of the women in the control period were admitted at 4 cm cervical dilation while the intervention periods had 60% of the women admitted at 4 cm. Most of the women had mothers and spouses for companions; 40.1% and 33.6% respectively. The overall mean of gestation was 38.3 weeks (see Table P > 0.000). There were no statistically significant differences between mode of delivery, length of labor, Apgar score, and the need to augment labor. The length of second stage though not statistically significant was shorter in the intervention period  or less while 32 (8.1%) women were in labor for longer than 16.7 h. The mean maternal satisfaction rate was higher in the intervention period (77.0) compared to the control period (68.1) (P < 0.001). Women who were having their first child, and those who were supported by siblings similarly had a significant increase in maternal satisfaction levels   compared to the control period (74.8%). Satisfaction with pain management was lowest across study periods; women in the intervention periods were more satisfied with their pain management (74.9%) compared to the control period at 56.9%. Overall, satisfaction with humaneness was the highest scored subscale with a higher satisfaction score in the intervention period (93%) compared to the control period at 79.5% see Fig. .Concerning particular features of care, women were more satisfied with the extent to which birth companions were present, encouraged them to change position and encouraged them in the intervention period  compared to (80.3%) in the control period. Surprisingly, we also note that women were more satisfied with the extent to which midwives were present as much as they wanted control group (83%) than the intervention group (61.7%) as shown in Table In this study, we assessed the efficacy of midwife-led role orientation of birth companions of on maternal satisfaction and labor outcomes. Results from our study showed that the mean maternal satisfaction rate was significantly higher in the intervention period compared to the control period. And, there were no statistically significant differences between mode of delivery, length of labor, Apgar score, and need to augment labor.The World Health Organization framework for improving quality of care for pregnant women during childbirth highlights experience of care as important as clinical care provision in achieving desired person-centred outcomes . In our . Studies show that Prime gravid anticipate labor pain, poor attitudes of health-care personnel and an insecure environment for birth during late pregnancy [High maternal satisfaction levels from sub-group analysis were noted among the women who were; at the regional referral hospital, younger, first-time mothers, and unmarried. Better results reported at the referral hospital could be attributed to the seniority of the midwives. Additionally, this was in a fairly urban setting and the effectiveness of the intervention was probably associated with income, and educational level of birth companions . This adregnancy . Consequregnancy . In 2016regnancy . ConsideSupport during childbirth is an important aspect of maternal satisfaction with care. Findings from a study conducted in Uganda showed that women desired the presence of someone most especially when health workers were not available. They needed reassurance, encouragement, and motivation for them to ably navigate through the birthing process . Our stuNon-significant findings on birth outcomes are similar to findings from a study where the rates of cesarean section delivery were almost identical in the intervention and control groups. Moreover no significant differences were noted in maternal and neonatal outcomes . The autA possible explanation for the contrast of findings in our study could be attributed to short duration of the intervention. The birth companions in our study had one session of orientation for 20 min on admission; this was probably not enough to make a difference. The current study found that orientation had a greater effect on the psychological outcomes  . ProbablWhereas the midwife providing an orientation for birth companions had no significant effect on the biological process of labor, it had an immediate positive effect on how women experienced care given. We also recognize that midwives providing a detailed orientation for birth companions may perhaps be a challenge with large numbers of women in labor at a given time. Also, the short time of interaction may limit building good relations with the midwife lessening the effect of the intervention. Midwives could consider group sessions, illustration chats and videos in the admission areas of busy maternity units. Evaluation of the acceptability and perceptions of birth companions and midwives regarding orienting birth companions is essential for implementation. Furthermore, we excluded women with special needs like mental illness, deaf or mute. Future studies could explore birth companionship for such women because they might need even more support during childbirth.The selected study design had the following strengths; Firstly, the facilities were their own controls hence buffering the effects of heterogeneity. Secondly, the stepped wedge design limited contamination of the intervention arm considering the socio nature of the intervention. Also, subgroup analysis of treatment effects of clusters and participants provided useful information for specific baseline characteristics of women. These findings could be used to tailor specific interventions for women.On the other hand, caution should be taken in generalizing the findings. The clusters were few and had a low power to determine true statistical differences. Secondly, observations collected soon after the roll-out of the intervention and observations collected after sometime could have been different which might have affected the overall treatment effect. Furthermore, only one session of orientation was done and this could have lessened the effect of the intervention. Also birth attendant details like sociodemographic characteristics and years of experience were not captured and could have affected the delivery of the intervention.. Our results suggest that role orientation of birth companions increases maternal satisfaction with experience of labor and has no effect on birth outcomes. Findings from this study may be of benefit in informing the implementation of the integration of birth companions in the admission process of the woman in labor in similar low-resource settings. Considering the staggered introduction of the intervention, we recommend that the study be repeated with larger samples and more clusters to assess the overall effect.In this study, we assessed the efficacy of midwife-led role orientation of birth companions on birth outcomes and maternal satisfaction


The incidence of birth defects is increased in children born after assisted reproductive technologies (ART). However, changes in ART over time could influence this incidence. To investigate this issue, we present the frequency and trends of birth defects in ART and natural pregnancies in Lombardy, Northern Italy, during the period 2014–2020.This is a population-based study using automated system of healthcare utilization (HCU) databases. ART pregnancies included only those obtained with conventional IVF or ICSI. After identifying the total number of deliveries, the rate of newborns with birth defects was compared between natural and ART pregnancies. A logistic regression model was used to calculate the adjusted odd ratio (OR). Analyses were repeated for every calendar year.Overall, 508,421 deliveries were identified, of which 14,067 (2.8%) were achieved after IVF-ICSI. A decreasing trend in birth defects over time was highlighted. The adjusted OR dropped from 1.40 (95%CI: 1.03–1.91) in 2014 to 0.92 (95%CI: 0.69–1.22) in 2020. During the study period, a significant reduction in multiple pregnancy and in the ratio of ICSI to conventional IVF was also observed, explaining at least in part the positive trend observed for birth defects.The increased risk of birth defects in children born after IVF-ICSI is not steady over time. A decline of this risk emerged in our region. Policy changes in ART may explain this beneficial effect.The online version contains supplementary material available at 10.1007/s10815-023-02732-z. Birth defects are a major public health issue since they represent the primary cause of infant mortality and lifetime disability . OverallThe link between assisted reproductive techniques (ART) and birth defects has been extensively studied. Concerns emerged with the advent of in vitro fertilization (IVF) and were re-fueled when Intra-cytoplasmatic sperm injection (ICSI) was introduced. This alarmism, however, progressively tempered over time . The mosThe determinants of the association between ART and birth defects are not fully elucidated. The underlying infertility was advocated to play a role, supporting the view that the reported increased risk would be a mere association rather than due to a causal link, but the evidence is not definitive , 14. EveOverall, even if available meta-analyses on birth defects of ART babies include thousands of newborns, the argument cannot be deemed solved. Of further relevance here is that ART techniques are in continuous evolution. The most striking events occurring over the last decade include the increase of elective single embryo transfer, the diffusion of extended culture, and the growing use of frozen transfers. In addition, there is an extreme heterogeneity among centers in terms of laboratory conditions and clinical policies, and changes are rapid , 17. OveFor this reason, we deemed of interest evaluating the possible modifications in the rate of birth defects in children born after ART over time. To this aim, we present the frequency and trends of birth defects in ART and natural pregnancies during the period 2014–2020 in Lombardy.We analyzed the automated system of healthcare utilization (HCU) databases from Lombardy, the largest region in Northern Italy accounting for about 10 million inhabitants, that collects information about all health services reimbursable by the National Health Service (NHS). The process of selection is reported in detail elsewhere and herein briefly summarized , 21. AccWe identified all deliveries in Lombardy that occurred between 1 January 2014 and 31 December 2020 from women beneficiaries of the NHS using the standard discharge form [scheda di dimissione ospedaliera (SDO)] and the certificate of delivery assistance [Certificato di assistenza al parto (CedAP)]. Exclusion criteria were the following: (i) deliveries which did not match to a SDO related to childbirth coded according to the International classification of disease, ninth revision (ICD-9) and/or the diagnosis-related groups (DRG), (ii) deliveries in which the newborn could not be linked to the mother, (iii) deliveries of mothers younger than 18 or older than 45 years at the delivery, (iv) deliveries before the 22th week or after the 42th week, and (v) deliveries with a lack of information concerning the mode of conception or the potential presence of major defects. Given our interest in investigating the rate of birth defects associated to IVF or ICSI, we also excluded pregnancies obtained with first-level techniques ), and cases reported to be ART but not precisely classified. Cohort selection was performed in February 2022.Detailed information regarding maternal characteristics, type of pregnancy , and mode of conception  were available for all deliveries in the CedAP. Cases of birth defects were identified exclusively using this database. Information on congenital malformations leading to medical pregnancy termination could not be detected. Diagnosis of congenital abnormalities was coded according to the International Classification of Diseases 9th edition—Clinical Modification (ICD-9-CM), Italian version, including structural abnormalities, biochemical abnormalities, and those that are chromosomal or otherwise genetic. Malformations were assessed by the neonatologist at birth. They were not confirmed by a geneticist. Minor defects were not generally coded, and any defect diagnosed after hospital discharge of the neonate could not be included. The included malformations are listed in Supplemental Table For the study, Statistical Analysis System Software  was used. Descriptive statistics were used to summarize the characteristics of mothers. Differences between women conceiving naturally and those undergoing ART were tested by the Chi-square test. The rate of newborns affected by major defects was calculated among natural pregnancies and among pregnancies achieved after ART. A binomial distribution model was used to determine the 95% CI of proportions. To assess the potential association between the use of ART and the detection of major defects at birth, a logistic regression model was implemented to estimate the odd ratio (OR) and the corresponding 95% CI of major defects among natural and ART pregnancies. We obtained crude OR and adjusted OR allowing for maternal sociodemographic features  (model 1). Maternal age was included as a categorical variable . A second model adjusted also for the plurality was computed (model 2). Finally, analyses were repeated in strata of type of ART.p < 0.0001).We identified 529,289 deliveries that took place in Lombardy between 1 January 2014 and 31 December 2020 from women beneficiaries of NHS. We excluded 3898 records because they did not match to a hospital ICD-9-CM code or to a DRG code related to childbirth, 3086 records related to mothers aged less than 18 or more than 45, 299 records because the gestational age was too short (< 22 weeks) or too long (> 42 weeks), 7626 records because the infant could not be linked to the mother because of a missing identification code, 2063 records because of a lack of information concerning the mode of conception or the potential presence of major defects, 1977 records because related to pregnancies obtained with first level techniques and 1919 because the ART modality was not specified. Overall, a total of 508,421 live births were included, of which 14,067 (2.8%) were achieved after IVF-ICSI. The number of cases per year progressively increased over the years, being 2.1%, 2.3%, 2.6%, 2.8%, 3.2%, 3.4%, and 3.2% in 2014, 2015, 2016, 2017, 2018, 2019, and 2020, respectively  . In addition, the relative proportion of ART babied born after ICSI decreases. The ratio between ICSI and conventional IVF shrunk over time  . Conversely, maternal age did not vary significantly over time  and 6815 (48.4%) women, respectively. Since multiple pregnancies and ICSI may increase the risk of birth defects, we evaluated whether these two variables changed over time. A statistically significant reduction was observed for multiple pregnancies after ART . The crude OR of birth defects was 1.15 (95% CI: 1.04–1.27), the adjusted OR was 1.09 (95% CI: 0.98–1.21). Data was analyzed separately also for conventional IVF and ICSI. The adjusted ORs were 1.01 (95% CI: 0.88–1.17) and 1.21 (95% CI: 1.01–1.34), respectively.upper panel, model 1). When we adjusted the model for plurality, the association between ART and birth defects was not statistically significant over the entire period of study .The details on the birth defects over time are presented in Table Finally, we evaluated separately the trends in IVF and ICSI pregnancies and failed to highlight marked differences in the trends  in 2014 to 0.92 (95%CI: 0.69–1.22) in 2020 , the magnitude of the association is milder, the overall adjusted OR being only 1.19 (95% CI: 0.98–1.21). Of utmost relevance here is the progressive reduction of this association during the 7 years period. This further supports the idea that some important and beneficial changes are ongoing, thus questioning the validity of results obtained from meta-analyses that included studies of pregnancies obtained several years ago. The reduction in birth defects may be driven by the advancement and changes of ART techniques and policies. Previous publications may not reflect the conditions of more recent IVF-ICSI settings. In fact, most studies included in the meta-analyses were performed more than 10 years ago. On the other hand, a previous study aimed at detecting changes in the rate of malformation over time failed to highlight any change . The autIn our opinion, the most striking determinant of the reduction in the risk of birth defects in our study is the parallel reduction in multiple births . Noteworthy, the reduction in ICSI use in our analysis contrasts with international trends [Other factors may have contributed to the improvement of the rate of birth defects. Firstly, the downward trend in ICSI procedure over the years may deserve attention  cases. If so, the above-mentioned infertility-related impact on the rate of birth defects could be diluted.https://www.iss.it/web/guest/rpma-dati-registro). Finally, as shown in Table Some limitations of our study should be recognized. The diagnosis of malformation is based on information available at the time of delivery. Thus, no data are available on malformations that can be diagnosed during the infant’s hospitalization until discharge, or later in the lifetime. One cannot exclude that malformations detected later in life could be differently distributed between ART and non-ART newborns. Moreover, we did not also report on minor defects. Furthermore, we have no information on pregnancies terminated early because of birth defects that could be expected to be the most severe. On the other hand, it must be underlined that the mode of assessment was not influenced by the modality of conception. One may infer that this bias may similarly affect natural and ART-mediated conceptions A second limitation is the reliability and completeness of the collected information. Data was collected from registries (as for most of the available evidence) and this modality is known to be exposed to some inaccuracies. Moreover, we did not have information on the indication for ART and details of the procedure. Given the relevance of infertility diagnosis in influencing the rate of malformation, data on the cause of infertility would have been of utmost interest. Collected information did not include the mode of semen collection, i.e., whether it was ejaculated or surgically retrieved, and whether ART was performed with donated gametes. However, these two aspects cannot be expected to play a role in explaining the observed results given their very marginal role in ART during the studied period ESM 2(DOCX 14 kb)ESM 3(DOCX 13 kb)