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Problem: Restrictions during the COVID-19 pandemic compromised maternal and newborn care., Background: Countries in the German speaking area share several clinical care guidelines but differed significantly in the strictness of COVID-19 protective measures., Aim: To investigate the quality of maternal and newborn care (QMNC) during the COVID-19 pandemic in the German-speaking area and explore associations between the reorganisational changes due to COVID-19 and QMNC, as described with WHO Standards-based Quality Measures., Methods: As part of the IMAgiNE EURO study (ClinicalTrials.gov: NCT04847336), we conducted an online survey on the QMNC in the German-speaking area, including women who gave birth in Germany, Switzerland, and Austria. Descriptive statistics, Spearman rank correlation coefficient and multivariable quantile regression were used., Findings: Out of a total of 70,721 women accessing the online questionnaire, 1,875 were included (Germany: n = 1,053, Switzerland: n = 494, Austria: n = 328). Significant differences across countries were found in Quality Measures. In Switzerland, women scored Quality Measures more favourable than in Germany and Austria in all four sub-indexes of QMNC. In Austria, Quality Measures gaps in the sub-index 'Experience of care' were higher. The sub-index 'Reorganisational changes due to COVID-19' correlated weakly to strongly with the other sub-indexes (between r = 0.33 and r = 0.62, p < 0.001 for all correlations)., Discussion: Midwives and other health professional should pay particular attention to the provision of respectful, high-quality care., Conclusion: To effectively improve QMNC, further research is essential to monitor the quality of care and develop targeted interventions beyond the COVID-19 pandemic addressing inherent challenges in the organisation and delivery of care., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Objectives: To examine quality of maternal and newborn care (QMNC) around childbirth in facilities in Belgium during the COVID-19 pandemic and trends over time., Design: A cross-sectional observational study., Setting: Data of the Improving MAternal Newborn carE in the EURO region study in Belgium., Participants: Women giving birth in a Belgian facility from 1 March 2020 to 1 May 2023 responded a validated online questionnaire based on 40 WHO standards-based quality measures organised in four domains: provision of care, experience of care, availability of resources and organisational changes related to COVID-19., Primary and Secondary Outcome Measures: Quantile regression analysis was performed to assess predictors of QMNC; trends over time were tested with the Mann-Kendall test., Results: 897 women were included in the analysis, 67% (n=601) with spontaneous vaginal birth, 13.3% (n=119) with instrumental vaginal birth (IVB) and 19.7% (n=177) with caesarean section. We found overall high QMNC scores (median index scores>75) but also specific gaps in all domains of QMNC. On provision of care, 21.0% (n=166) of women who experienced labour reported inadequate pain relief, 64.7% (n=74) of women with an instrumental birth reported fundal pressure and 72.3% (n=86) reported that forceps or vacuum cup was used without their consent. On experience of care, 31.1% (n=279) reported unclear communication, 32.9% (n=295) reported that they were not involved in choices,11.5% (n=104) stated not being treated with dignity and 8.1% (n=73) experienced abuse. Related to resources, almost half of the women reported an inadequate number of healthcare professionals (46.2%, n=414). Multivariable analyses showed significantly lower QMNC scores for women with an IVB (-20.4 in the 50th percentile with p<0.001 and 95% CI (-25.2 to -15.5)). Over time, there was a significant increase in QMNC Score for 'experience of care' and 'key organisational changes due to COVID-19' (trend test p< 0.05)., Conclusions and Relevance: Our study showed several gaps in QMNC in Belgium, underlying causes of these gaps should be explored to design appropriate interventions and policies., Trial Registration Number: NCT04847336., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Introduction: Maternal-neonatal healthcare services were severely disrupted during the COVID-19 pandemic in even high-income countries within the World Health Organization (WHO) European Region. The objective of this study was to compare trends in the quality of maternal and neonatal care (QMNC) in Sweden and Norway to 12 other countries from the WHO European Region during the COVID-19 pandemic, and to identify domains for improvement., Material and Methods: This cross-sectional study included women giving birth in Europe from March 1, 2020 to December 31, 2022. Women answered an online, anonymous questionnaire which included 40 WHO Standard-based Quality Measures collectively scored as the total QMNC index (0-400) and separately in four subdomains (0-100): provision of care, experience of care, availability of human and physical resources, and reorganizational changes due to COVID-19. To assess reported QMNC changes over time, we used adjusted quantile regression models., Clinicaltrials: gov Identifier: NCT04847336., Results: Of the 45151 women included in the study, 13 117 (29.1%) were from Sweden and Norway and 32034 (70.9%) from the 12 WHO European countries. The total QMNC index for Sweden and Norway (median: 325, IQR: 285-355) was higher than the 12 WHO European countries (median: 315, IQR: 265-350, p < 0.001) as were trends in QMNC index over time (Sweden and Norway median: 310-345; 12 WHO European countries median: 305-340). Sweden and Norway also had higher scores in three-of-four QMNC subdomains, with the 12 WHO European countries scoring higher only for reorganizational changes due to COVID-19. In adjusted quantile models of the total QMNC index, Sweden and Norway had higher scores, with largest differences in the lower quantiles (p < 0.001 in all percentiles)., Conclusions: Across Europe, there are significant gaps in the quality of maternal-neonatal healthcare services. Although women giving birth in Sweden and Norway reported higher QMNC scores in all subdomains except for "reorganizational changes due to COVID-19," there is room for improvement and shared learning across Europe. Policymakers should prioritize long-term investments in maternal and neonatal healthcare, ensuring that facilities are adequately equipped during public health crises and that all women have access to high-quality, evidence-based, equitable, and respectful care., (© 2024 The Author(s). Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Background: The COVID-19 pandemic had an important psychological impact on children and their families. This study aims to explore paediatric health services users' perceptions of quality of care (QOC) and COVID-19-related fears, and their evolution over time in relation to COVID-19 pandemic., Methods: In a multicentre cross-sectional study involving 11 public hospitals providing paediatric care across the Italian territory, we collected data from services users through a validated questionnaire. We analysed four indicators-(1) QOC perceived in relation to COVID-19; (2) overall QOC perceived; (3) fear of accessing health services due to COVID-19; (4) fear of contracting COVID-19 in hospital-and calculated Spearman's correlation indexes (ρ) with the number of COVID-19 new cases over time. Subgroup analyses were conducted by macroregions and single facility., Results: Data from 956 services users were analysed. QOC indicators were stable over time at values close to the maximum (range 77-100 and median 100 for COVID-19 QOC, range 74-98 and median 80 for overall QOC), and no correlations were found with the COVID-19 new cases (ρ=-0.073 and -0.016, respectively). Fear of accessing care and fear of contracting the infection varied over time in between 0%-52% and 0%-53%, respectively, but did not correlate directly with number of COVID-19 new cases (ρ=0.101, 0.107 and 0.233, 0.046, respectively). At subgroup analyses, significantly higher frequencies of fear (p values <0.05) and lower QOC (p values <0.001) were reported in South Italy, and three facilities showed moderate correlation between these indicators., Conclusions: COVID-19-related fears and perceived QOC may be mediated by more complex cultural and facility/regional-level factors, than simply by epidemic peaks. Subgroup analyses can help unpack major differences within the same country., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Collecting women's views and suggestions for improving quality of maternal-newborn care (QMNC) is a crucial aspect of maternity care evaluation often overlooked in Italy and globally. Childbearing women experienced numerous challenges during the COVID-19 pandemic including the rapid and significant reorganization of maternity services and care. Their perspective on what to prioritize for QMNC improvement is hence pivotal. The aim of this study was to explore maternal suggestions for QMNC improvement from women who gave birth during the two years of the COVID-19 pandemic., Methods: Data were collected from an open-ended question included in a validated online questionnaire administered to mothers who gave birth in an Italian hospital between November 2020 to March 2022. The responses were analyzed using thematic analysis and mapped against the WHO Standards for improving QMNC and the WHO Framework of QMNC., Results: The thematic analysis identified five main themes from the 2017 responses: 1) Support for mothers during the postnatal period; 2) Better use of resources; 3) Improvement of the maternity environment; 4) Reconsideration of organizational aspects; and 5) Guarantee of respectful practices. Women commented on all dimensions of the WHO framework except for two provision of care subdomains 'actionable information and functional referral systems'., Conclusions: This is the first qualitative study in Italy focusing on women's suggestions for improving QMNC during the COVID-19 pandemic. Its findings can be used to inform what aspects of QMNC need improvement in Italy. Collection of women's views should be incorporated in routine monitoring of the QMNC, and data should be used for quality improvement purposes., Competing Interests: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none was reported., (© 2024 Fumagalli S. et al.)

Competing Interests: We declare no competing interests. We thank Linda M Richter for her valuable comments and the US Agency for International Development for their financial support of the Child Health Accountability Tracking group (US Department of State [68023]). The authors alone are responsible for the views expressed in this article and they do not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated. Members of the Child Health Accountability Tracking Technical Advisory Group are listed in the appendix.

Background: Health workers' (HWs') perspectives on the quality of maternal and newborn care (QMNC) are not routinely collected. In this cross-sectional study, we aimed to document HWs' perspectives on QMNC around childbirth in 12 World Health Organization (WHO) European countries., Methods: HWs involved in maternal/neonatal care for at least one year between March 2020 and March 2023 answered an online validated WHO standards-based questionnaire collecting 40 quality measures for improving QMNC. A QMNC index (score 0-400) was calculated as a synthetic measure., Results: Data from 4143 respondents were analysed. For 39 out of 40 quality measures, at least 20% of HWs reported a 'need for improvement', with large variations across countries. Effective training on healthy women/newborns management (n = 2748, 66.3%), availability of informed consent job aids (n = 2770, 66.9%), and effective training on women/newborns rights (n = 2714, 65.5%) presented the highest proportion of HWs stating 'need for improvement'. Overall, 64.8% (n = 2684) of respondents declared that HWs' numbers were insufficient for appropriate care (66.3% in Portugal and 86.6% in Poland), and 22.4% described staff censorship (16.3% in Germany and 56.7% in Poland). The reported QMNC index was low in all countries (Poland median (MD) = 210.60, interquartile range (IQR) = 155.71, 273.57; Norway MD = 277.86; IQR = 244.32, 308.30). The 'experience of care' domain presented in eight countries had significantly lower scores than the other domains (P < 0.001). Over time, there was a significant monthly linear decrease in the QMNC index (P < 0.001), lacking correlation with the coronavirus disease 2019 (COVID-19) pandemic trends (P > 0.05). Multivariate analyses confirmed large QMNC variation by country. HWs with <10 years of experience, HWs from public facilities, and midwives rated QMNC with significantly lower scores (P < 0.001)., Conclusions: HWs from 12 European countries reported significant gaps in QMNC, lacking association with COVID-19 pandemic trends. Routine monitoring of QMNC and tailored actions are needed to improve health services for the benefit of both users and providers., Registration: ClinicalTrials.gov NCT04847336., Competing Interests: Disclosure of interests: The authors completed the ICMJE Disclosure of Interest Form (available upon request from the corresponding author) and disclose no relevant interests., (Copyright © 2024 by the Journal of Global Health. All rights reserved.)

Background: There is little experience on the use of the WHO Standards for improving the quality of care (QOC) for children. We describe the use of four prioritised WHO Standard-based Quality Measures to assess the provision of care for children with pain in emergency departments (EDs)., Methods: In a multicentre observational study in 10 EDs with different characteristics in Italy, we collected data on 3355 children accessing the EDs between January 2019 and December 2020. The association between children and facility characteristics and quality measures was analysed through multivariate analyses., Results: The proportion of children whose pain was measured was 68.7% (n=2305), with extreme variations across different centres (from 0.0% to 99.8%, p<0.001). The proportion of children treated for pain was 28.9% (n=970) again with a wide range (5.3%-56.3%, p<0.001). The difference between the frequency of children with pain measured and pain treated varied widely between the facilities (ranging from -24.3 to 82). Children with moderate and severe pain were more frequently treated (48.9% and 62.9% of cases, respectively), although with large variations across centres (ranges: 0%-74.8% and 0%-100% respectively, p<0.001). After correction for children's characteristics, the variable more strongly associated with analysed outcomes was the facility which the child accessed for care. Being a facility in Northern Italy was associated with a higher rate of pain measurement (67.3%-95% CI: 39.9% to 94.6%, p<0.001) compared with facilities in South Italy (-22.1% lower (95% CI: -41.7% to -2.50%, p=0.03)., Conclusions: The use of few WHO Standard-based measures related to pain can help identifying priority gaps in QOC for children and in monitoring it over time. There is a need for more implementation research to establish which are the most sustainable and effective interventions to improve the QOC for acute pain in children., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: There is little experience in the use of the WHO Standards for improving the quality of care (QOC) for children at the facility level. We describe the use of 75 WHO Standard based Quality Measures to assess paediatric QOC, using service users as a source of data, in Italy., Study Design: In a cross-sectional study including 12 hospitals, parents/caregivers of admitted children completed a validated questionnaire including 75 Quality Measures: 40 pertinent to the domain of experience of care; 25 to physical/structural resources; 10 to COVID-19 reorganisational changes. Univariate and multivariate analyses were conducted., Results: Answers from 1482 service users were analysed. Physical resources was the domain with the higher frequency of reported gaps in QOC, with key gaps (higher rates of responders reporting need for improvement and low variability across centres) being: (1) quality of meals (48.1%; range across facilities: 35.3%-61.7%); (2) presence of cooking areas (50.9%; range: 34.6%-70.0%); (3) spaces for family/friends (51.3%; range: 31.8%-77.4%). For experience of care , the most critical gap was the information on the rights of the child (76.6%; range: 59.9%-90.4%), with most other Quality Measures showing an overall frequency of reported need for improvement ranging between 5% and 35%. For reorganisational changes due to COVID-19 an improvement was felt necessary by <25% of responders in all Quality Measures, with low variability across centres. At the multivariate analyses, factors significantly associated with the QOC Index largely varied by QOC domain., Conclusions: The use of the 75 prioritised Quality Measures, specific to service users' perspective, enabled the identification of both general and facility-specific gaps in QOC. Based on these findings, quality improvement initiatives shall focus on a core list of selected Quality Measures common to all facilities, plus on an additional list of Quality Measures as more relevant in each facility., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: There is little experience in implementing the WHO Standards for improving the quality of care (QOC) for children. We describe the use of 75 WHO-Standard based Quality Measures to assess paediatric QOC, using health workers (HWs) as data sources., Design: Cross-sectional study., Setting: 12 Italian hospitals., Participants: The minimum target of 75% of HWs was reached in all facilities; answers from 598 HWs were analysed., Primary and Secondary Outcome Measures: 75 prioritised WHO Quality Measures were collected using a validated, and Italian-language questionnaire exploring views of HWs providing care to children. A QOC index was also calculated based on the assessed Quality Measures., Results: In both the domain of resources and work organisation, most Quality Measures showed a high overall frequency of reported 'need for improvement', with high variability across hospitals. Key needs for improvement included: availability of clear and complete protocols (eg, on paediatric emergencies: 44.6%; range 10.6%-92.6%); clear hospitalisation criteria for diarrhoea (50.5%; range 30.3%-71.7%); number of hand-washing stations (13.2%; range 3.4%-37.0%); equipped working rooms with computers for HWs (66.1%; range: 32.1%-97.0%); training (eg, on pain management: 43.5%; range 17.9%-76.7%), periodic discussion of clinical cases (43.5%; range 8.1%-83.7%) audits (48.8%; range 29.7%-76.7%); and all indicators related to system to improve QOC. Factors significantly associated with a lower QOC Index included HWs working in facilities in Southern Italy (p=0.001) and absence of a paediatric emergency department (p=0.011)., Conclusions: The use of the 75 prioritised Quality Measures, specific to HWs provide valuable data on paediatric QOC, which can be used to drive a quality improvement process., Competing Interests: Competing interests: No, there are no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Experience is lacking on the implementation of the WHO standards for improving the quality of care (QOC) for children at facility level. We describe the use of 10 prioritised WHO standard-based quality measures to assess provision of care for children with acute respiratory infections (ARI) in Italy., Methods: In a multicentre observational study across 11 emergency departments with different characteristics, we collected 10 WHO standard-based quality measures related to case management of children with ARI and no emergency/priority signs. Univariate and multivariate analyses were conducted., Results: Data from 3145 children were collected. Major differences in QOC across facilities were observed: documentation of saturation level and respiratory rate varied from 34.3% to 100% and from 10.7% to 62.7%, respectively (p<0.001); antibiotic prescription rates ranged from 22.6% to 80.0% (p<0.001), with significant differences in the pattern of prescribed antibiotic; hospitalisations rates ranged between 2.3% and 30.6% (p<0.001). When corrected for children's individual sociodemographic and clinical characteristics, the variable more consistently associated with each analysed outcome was the individual facility where the child was managed. Higher rates of antibiotics prescription (+33.1%, p<0.001) and hospitalisation (+24.7%, p<0.001) were observed for facilities in Southern Italy, while university centres were associated with lower hospitalisation rates (-13.1%, p<0.001), independently from children's characteristics., Conclusions: The use of 10 WHO standard-based measures can help quickly assess QOC for children with ARI. There is an urgent need to invest more in implementation research to identify sustainable and effective interventions to ensure that all children receive high QOC., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: There is no documented experience in the use of the WHO standards for improving the quality of care (QOC) for children at the facility level. We describe the use of 10 prioritised WHO-Standard-based Quality Measures to assess QOC for children with acute diarrhoea (AD) in Italy., Methods: In a multicentre observational study in 11 paediatric emergency departments with different characteristics and geographical location, we collected data on 3061 children aged 6 months to 15 years with AD and no complications. Univariate and multivariate analyses were conducted., Results: Study findings highlighted both good practices and gaps in QoC, with major differences in QOC across facilities. Documentation of body weight and temperature varied from 7.7% to 98.5% and from 50% to 97.7%, respectively (p<0.001); antibiotic and probiotic prescription rates ranged from 0% to 10.1% and from 0% to 80.8%, respectively (p<0.001); hospitalisations rates ranged between 8.5% and 62.8% (p<0.001); written indications for reassessment were provided in 10.4%-90.2% of cases (p<0.001). When corrected for children's individual characteristics, the variable more consistently associated with each analysed outcome was the individual facility. Higher rates of antibiotics prescription (+7.6%, p=0.04) and hospitalisation (+52.9%, p<0.001) were observed for facilities in Southern Italy, compared with university centres (-36%, p<0.001), independently from children characteristics. Children's clinical characteristics in each centre were not associated with either hospitalisation or antibiotic prescription rates., Conclusions: The 10 prioritised WHO-Standard-based Quality Measures allow a rapid assessment of QOC in children with AD. Action is needed to identify and implement sustainable and effective interventions to ensure high QOC for all children., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Benefits of different types of family-centred care (FCC) interventions in neonatal intensive care units (NICUs) have been reported. However, a comprehensive review of existing FCC intervention studies was lacking., Objective: This review aimed at synthesising the characteristics of FCC interventions, related outcomes and measurement methods in randomised controlled trials (RCTs) in NICU, and providing menus of options to favour implementation and further research., Methods: We searched PubMed, EMBASE, Web of Science and the Cochrane Library up to 31 January 2022. Interventions were mapped according to five categories as defined by a previous Cochrane review. We described outcome types, measurement populations, measurement methods and timelines. Subgroup analyses were also performed., Results: Out of 6583 studies identified, 146 met eligibility criteria. Overall, 52 (35.6%) RCTs tested more than one category of intervention, with a large variety of combinations, with the most frequent category of intervention being the educational (138 RCTs, 94.5%). We identified a total of 77 different intervention packages, and RCTs comparing the same interventions were lacking. The 146 RCTs reported on 425 different outcomes, classified in 13 major categories with parental mental health (61 RCTs, 41.8% of total RCTs) being the most frequent category in parents, and neurobehavioural/developmental outcomes being the most frequent category in newborns (62 RCTs, 42.5%). For several categories of outcomes almost every RCT used a different measurement method. Educational interventions targeting specifically staff, fathers, siblings and other family members were lacking or poorly described. Only one RCT measured outcomes in health workers, two in siblings and none considered other family members., Conclusions: A large variety of interventions, outcomes and measurement methods were used in FCC studies in NICU. The derived menus of options should be helpful for researchers and policy makers to identify interventions most suitable in each setting and to further standardise research methods., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Studies comparing the frequency of different mental health conditions across different settings and evaluating their association with parental participation in newborn care are lacking. We aimed at evaluating the frequency of parental stress, anxiety and depression, along with the level of participation in newborn care, among parents of newborns in Italy, Brazil and Tanzania., Methods: Parental stress, anxiety, depression and participation in care were assessed prospectively in parents of newborns in eight neonatal intensive care units (NICUs) utilising: the Parental Stressor Scale in NICU (PSS:NICU); the Edinburgh Postnatal Depression Scale (EPDS) and EPDS-Anxiety subscale (EPDS-A); the Index of Parental Participation in NICU (IPP-NICU). Univariate and multivariate analyses were conducted., Results: Study outcomes were assessed on 742 parents (Brazil=327, Italy=191, Tanzania=224). Observed scores suggested a very high frequency of stress, anxiety and depression, with an overall estimated frequency of any of the mental health condition of 65.1%, 52.9% and 58.0% in Brazil, Italy, Tanzania, respectively (p<0.001). EPDS scores indicating depression (cut-off: ≥13 for Brazil and Tanzania, ≥12 for Italy) were significantly more frequent in Tanzania (52.3%) when compared with either Brazil (35.8%) and Italy (33.3%) (p<0.001). Parental participation in care was also significantly higher in Tanzania (median IPP-NICU=24) than in the other two countries (median=21 for Brazil, 18 for Italy, p<0.001). Severe stress (PSS:NICU ≥4) was significantly more frequently reported in Brazil (22.6%), compared with Italy (4.7%) and Tanzania (0%, p<0.001). Factors independently associated with either parental stress, anxiety or depression varied by country, and a significant association with parental participation in care was lacking., Conclusions: Study findings suggest that parental stress, anxiety and depression are extremely frequent in NICUs in all countries despite diversity in the setting, and requiring immediate action. Further studies should explore the appropriate level of parental participation in care in different settings., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Different definitions of family-centred care (FCC) exist in the newborn setting, and many FCC interventions have been tested, while a comprehensive review synthesising characteristics of existing intervention studies is still lacking., Objective: This review aims at summarising the characteristics of randomised controlled trials (RCTs) on FCC interventions in neonatal intensive care units., Methods: We searched PubMed, Embase, Web of Science and the Cochrane Library up to 31 January 2022, and reference lists of included studies and other reviews. Interventions were grouped into five categories according to a previous Cochrane review: (1) family support, (2) educational, (3) communication, (4) environmental interventions and (5) family-centred policies. Subgroup analyses by time period (RCTs published before vs after 2016) and by country income (based on the World Bank Classification) were conducted., Results: Out of 6583 retrieved studies, 146 RCTs met the eligibility criteria, with 53 (36.3%) RCTs published after 2016. Overall, 118 (80.8%) RCTs were conducted in high-income countries, 28 (19.1%) in middle-income countries and none in low-income countries. Only two RCTs were multicountry. Although mothers were the most frequent caregiver involved, fathers were included in 41 RCTs (28.1%). Very few studies were conducted in at-term babies (nine RCTs); siblings (two RCTs) and other family members (two RCTs), maternity care units (two RCTs). The role of health professionals was unclear in 65 (44.5%) RCTs. A large variety of intervention combinations was tested, with 52 (35.6%) RCTs testing more than 1 category of interventions, and 24 (16.4%) RCTs including all 5 categories., Conclusion: There is a large and rising number of RCTs on FCC interventions in neonatal intensive care units, with specific research gaps. The large variety of FCC interventions, their high complexity, the need to tailor them to the local context and major gaps in implementation suggest that implementation research is the current priority., Competing Interests: Competing interests: The authors have no financial relationships relevant to this article to disclose. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The COVID-19 pandemic has challenged the provision of maternal care. The IMAgiNE EURO study investigates the Quality of Maternal and Newborn Care during the pandemic in over 20 countries, including Switzerland., Aim: This study aims to understand women's experiences of disrespect and abuse in Swiss health facilities during the COVID-19 pandemic., Methods: Data were collected via an anonymous online survey on REDCap®. Women who gave birth between March 2020 and March 2022 and answered an open-ended question in the IMAgiNE EURO questionnaire were included in the study. A qualitative thematic analysis of the women's comments was conducted using the International Confederation of Midwives' RESPECT toolkit as a framework for analysis., Findings: The data source for this study consisted of 199 comments provided by women in response to the open-ended question in the IMAgiNE EURO questionnaire. Analysis of these comments revealed clear patterns of disrespect and abuse in health facilities during the COVID-19 pandemic. These patterns include non-consensual care, with disregard for women's choices and birth preferences; undignified care, characterised by disrespectful attitudes and a lack of empathy from healthcare professionals; and feelings of abandonment and neglect, including denial of companionship during childbirth and separation from newborns. Insufficient organisational and human resources in health facilities were identified as contributing factors to disrespectful care. Empathic relationships with healthcare professionals were reported to be the cornerstone of positive experiences., Discussion: Swiss healthcare facilities showed shortcomings related to disrespect and abuse in maternal care. The pandemic context may have brought new challenges that compromised certain aspects of respectful care. The COVID-19 crisis also acted as a magnifying glass, potentially revealing and exacerbating pre-existing gaps and structural weaknesses within the healthcare system, including understaffing., Conclusions: These findings should guide advocacy efforts, urging policy makers and health facilities to allocate adequate resources to ensure respectful and high-quality maternal care during pandemics and beyond., (© 2024. The Author(s).)

Competing Interests: The authors declare that they do not have any conflicts of interest.

Background: This study aimed at documenting the levels of stress, depression, anxiety and participation in care among mothers versus fathers of newborns hospitalised in a third-level neonatal intensive care unit (NICU) in Northern Italy., Methods: Parental stress, depression and anxiety were assessed by the Parental Stressor Scale in NICU (PSS:NICU), the Edinburgh Postnatal Depression Scale (EPDS) and the State-Trait Anxiety Inventory (STAI). Participation in care was evaluated with the Index of Parental Participation. Differences between mothers and fathers were assessed with the Mood's median test and z-test, respectively for continuous and discrete variables. Multivariate analyses controlling for potential confounders were performed to confirm gender differences., Results: 191 parents (112 mothers and 79 fathers) were enrolled. Mothers reported significantly higher median scores for stress (2.9 vs 2.2, p<0.001) and trait anxiety (37 vs 32, p=0.004) and higher depression rates (EPDS ≥12: 43.8% vs 19.0%, p<0.001). 'High stress' (PSS:NICU ≥3) was reported by 45.5% of mothers compared with 24.1% of fathers (p=0.004). The frequency of the three conditions simultaneously was significantly higher among mothers (20.0% vs 3.8%, p=0.016), with the vast majority of mothers (76.0%) suffering from at least one condition compared with less than half of fathers (45.3%, p<0.001). Participation in care was more frequent in mothers (median score: 19 vs 15, p<0.001), with the exception of activities related to advocacy (median 5 vs 4, p=0.053). In a multivariate analysis, gender differences in mental health outcomes did not change., Conclusions: Routine screening of mental distress among parents of infants in NICU is warranted, and gender differences need to be acknowledged in order to deliver tailored support and to promote collaboration with the family of vulnerable newborns. Knowledge and skills on how to prevent and cope with mental distress of parents should be part of the core curriculum of staff working in NICU., Competing Interests: Competing interests: No, there are no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To report on suicide plans and attempts among Brazilian physicians and to investigate the associated risk factors., Methods: From January 2018 to January 2019, a nationwide online survey was conducted among Brazilian physicians using the Tool for Assessment of Suicide Risk and the Satisfaction with Life Scale. Multivariate exploratory associations of demographic, psychological, and work-related factors were performed on reports of suicide plans and attempts., Results: Of the 4,148 participants, 1,946 (53.5%) were male, 2,527 (60.9%) were 30 to 60 years old, 2,675 (64.5%) had two to four jobs, and 1,725 (41.6%) worked 40 to 60 hours a week. The overall prevalence of suicide plans was 8.8% (n=364), and suicide attempts were reported by 3.2% (n=133) of participants. Daily emotional exhaustion (ORadj = 7.857; 95%CI 2.282-27.051, p = 0.002), weekly emotional exhaustion (ORadj = 7.953; 95%CI 2.403-26.324, p = 0.001), daily frustration at work (ORadj = 3.093; 95%CI 1.711-5.588, p < 0.001), and bisexuality (ORadj = 5.083; 95%CI 2.544-10.158, p < 0.001) were significantly associated with higher odds of suicide. Extremely dissatisfied physicians reported suicide plans and attempts in 38.3% of cases, whereas extremely satisfied physicians reported suicide plans and attempts in only 2.8% of cases (p < 0.001)., Conclusion: Brazilian physicians with a history of suicide plans and attempts express emotional exhaustion and frustration at work. There is an urgent need for actions to promote professional safeguards and resilience., Competing Interests: The authors report no conflicts of interest.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA generally becomes undetectable in upper airways after a few days or weeks postinfection. Here we used a model of viral infection in macaques to address whether SARS-CoV-2 persists in the body and which mechanisms regulate its persistence. Replication-competent virus was detected in bronchioalveolar lavage (BAL) macrophages beyond 6 months postinfection. Viral propagation in BAL macrophages occurred from cell to cell and was inhibited by interferon-γ (IFN-γ). IFN-γ production was strongest in BAL NKG2r + CD8 + T cells and NKG2A lo natural killer (NK) cells and was further increased in NKG2A lo NK cells after spike protein stimulation. However, IFN-γ production was impaired in NK cells from macaques with persisting virus. Moreover, IFN-γ also enhanced the expression of major histocompatibility complex (MHC)-E on BAL macrophages, possibly inhibiting NK cell-mediated killing. Macaques with less persisting virus mounted adaptive NK cells that escaped the MHC-E-dependent inhibition. Our findings reveal an interplay between NK cells and macrophages that regulated SARS-CoV-2 persistence in macrophages and was mediated by IFN-γ., (© 2023. The Author(s).)

(1) Background: This implementation study reports on the results of the mobile vaccination teams' (MVTs) activities during the first two years of the COVID-19 pandemic in Kyrgyzstan, when other vaccination services were disrupted. (2) Methods: Through a national health system-strengthening project under an order of the Ministry of Health, in 2020, the number of MVTs was increased, focusing on internal immigrant settlements around the cities of Bishkek and Osh and geographically remote areas. MVTs provided free vaccination services. (3) Results: MVTs vaccinated a total of 125,289 and 158,047 children in 2020 and 2021, respectively. The higher contribution of MVTs to vaccination coverage was in children under 5 years of age, with the three top vaccines being IPV (8.9%), MMR (7%), and PCV (6.6%). In 2021, 13,000 children who had not received an IPV vaccination and 8692 children who had not received the Pentavalent vaccine (DPT-HBV-Hib) were reached. The number of cases of vaccine-preventable disease reported in official statistics has reduced over time. (4) Conclusions: MVTs increased vaccination coverage in Kyrgyzstan, in particular in remote regions and migrant settlements, where it accounted for a considerable proportion of the vaccinated. This study adds to previous evidence in the literature of the role of MVTs as a strategy to improve immunization in hard-to-reach populations, particularly children.

Background: Evidence has shown that restrictions during the COVID-19 pandemic have negatively affected breastfeeding support and outcomes in hospitals in many countries. The aims of the study were to describe exclusive breastfeeding rates and identify factors associated with exclusive breastfeeding at hospital discharge among women who gave birth during the COVID-19 pandemic in Israel., Methods: A cross-sectional online anonymous survey based on WHO standards for improving quality of maternal and newborn care in health facilities was conducted among a sample of women who gave birth to a healthy singleton infant in Israel during the pandemic (between March 2020 and April 2022). The socio-ecological approach was employed to examine intrapersonal, interpersonal, organizational, and community/society factors associated with exclusive breastfeeding at hospital discharge according to women perspectives., Results: Among the 235 Israeli participants, 68.1% exclusively breastfed, 27.7% partially breastfed, and 4.2% did not breastfeed at discharge. Results of the adjusted logistic regression model showed that factors significantly associated with exclusive breastfeeding were the intrapersonal factor of multiparity (adjusted OR 2.09; 95% Confidence Interval 1.01,4.35) and the organizational factors of early breastfeeding in the first hour (aOR 2.17; 95% CI 1.06,4.45), and rooming-in (aOR 2.68; 95% CI 1.41,5.07)., Conclusions: Facilitating early breastfeeding initiation and supporting rooming-in are critical to promoting exclusive breastfeeding. These factors, reflecting hospital policies and practices, along with parity, are significantly associated with breastfeeding outcomes and highlight the influential role of the maternity environment during the COVID-19 pandemic. Maternity care in hospitals should follow evidence-based breastfeeding recommendations also during the pandemic, promoting early exclusive breastfeeding and rooming-in among all women, with particular attention to providing lactation support to primiparous women., Trial Registration: Clinical Trials NCT04847336., (© 2023. The Author(s).)

Objective: To examine prevalence of novel newborn types among 541 285 live births in 23 countries from 2000 to 2021., Design: Descriptive multi-country secondary data analysis., Setting: Subnational, population-based birth cohort studies (n = 45) in 23 low- and middle-income countries (LMICs) spanning 2000-2021., Population: Liveborn infants., Methods: Subnational, population-based studies with high-quality birth outcome data from LMICs were invited to join the Vulnerable Newborn Measurement Collaboration. We defined distinct newborn types using gestational age (preterm [PT], term [T]), birthweight for gestational age using INTERGROWTH-21st standards (small for gestational age [SGA], appropriate for gestational age [AGA] or large for gestational age [LGA]), and birthweight (low birthweight, LBW [<2500 g], nonLBW) as ten types (using all three outcomes), six types (by excluding the birthweight categorisation), and four types (by collapsing the AGA and LGA categories). We defined small types as those with at least one classification of LBW, PT or SGA. We presented study characteristics, participant characteristics, data missingness, and prevalence of newborn types by region and study., Results: Among 541 285 live births, 476 939 (88.1%) had non-missing and plausible values for gestational age, birthweight and sex required to construct the newborn types. The median prevalences of ten types across studies were T+AGA+nonLBW (58.0%), T+LGA+nonLBW (3.3%), T+AGA+LBW (0.5%), T+SGA+nonLBW (14.2%), T+SGA+LBW (7.1%), PT+LGA+nonLBW (1.6%), PT+LGA+LBW (0.2%), PT+AGA+nonLBW (3.7%), PT+AGA+LBW (3.6%) and PT+SGA+LBW (1.0%). The median prevalence of small types (six types, 37.6%) varied across studies and within regions and was higher in Southern Asia (52.4%) than in Sub-Saharan Africa (34.9%)., Conclusions: Further investigation is needed to describe the mortality risks associated with newborn types and understand the implications of this framework for local targeting of interventions to prevent adverse pregnancy outcomes in LMICs., (© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Background: Recent evidence revealed significant gaps in the quality of maternal and newborn care in the World Health Organization (WHO) European Region (EUR) countries. Collecting and analyzing women's views on their needs and priorities is crucial for developing actions to improve the quality of maternal and newborn care. With this study from the IMAgiNE EURO Project, we aimed to add to previous quantitative studies by analysing emerging themes from women's suggestions on how to improve the quality of maternal and newborn care during facility-based birth in Italy during the COVID-19 pandemic., Methods: We collected data from mothers giving birth during the coronavirus 2019 (COVID-19) pandemic using a validated online anonymous WHO standard-based questionnaire consisting of open-ended questions. Using a word co-occurrence network (WCON), we analysed responses in Italian from women who gave birth between March 2020 and March 2022. This approach entails a graphical representation of word pairings that frequently co-occur across sentences and compose clusters., Results: The texts, produced by 2010 women participating in the study, consisted of 79 204 words and 3833 sentences. Eight clusters emerged with WCON, the three largest of which were related to companionship during childbirth, breastfeeding support, and physical resources. The term "swab", associated with other terms in the COVID-19 domain, had the highest degree of centrality, thus representing a core topic., Conclusions: The key emerging themes from women's suggestions can be used to shape policies to improve the quality of care for mothers and newborns. Our WCON analysis offers a valid approach to quickly screen large textual data on quality of care, providing a first set of major themes identified by clusters. As such, it could be used to improve documentation of service users' suggestions promoting the engagement of both researchers and policymakers., Registration: ClinicalTrials.gov: NCT04847336., Competing Interests: Disclosure of interest: The authors completed the ICMJE Disclosure of Interest Form (available upon request from the corresponding author) and disclose no relevant interests., (Copyright © 2023 by the Journal of Global Health. All rights reserved.)

Background: Little is known about women's experience of care and views on early breastfeeding during the COVID-19 pandemic in Norway., Methods: Women (n = 2922) who gave birth in a facility in Norway between March 2020 and June 2021 were invited to answer an online questionnaire based on World Health Organization (WHO) Standard-based quality measures, exploring their experiences of care and views on early breastfeeding during the COVID-19 pandemic. To examine associations between year of birth (2020, 2021) and early breastfeeding-related factors, we estimated odds ratios (ORs) with 95% confidence intervals (CIs) using multiple logistic regression. Qualitative data were analysed using Systematic Text Condensation., Results: Compared to the first year of the pandemic (2020), women who gave birth in 2021 reported higher odds of experiencing adequate breastfeeding support (adjOR 1.79; 95% CI 1.35, 2.38), immediate attention from healthcare providers when needed (adjOR 1.89; 95% CI 1.49, 2.39), clear communication from healthcare providers (adjOR 1.76; 95% CI 1.39, 2.22), being allowed companion of choice (adjOR 1.47; 95% CI 1.21, 1.79), adequate visiting hours for partner (adjOR 1.35; 95% CI 1.09, 1.68), adequate number of healthcare providers (adjOR 1.24; 95% CI 1.02, 1.52), and adequate professionalism of the healthcare providers (adjOR 1.65; 95% CI 1.32, 2.08). Compared to 2020, in 2021 we found no difference in skin-to-skin contact, early breastfeeding, exclusive breastfeeding at discharge, adequate number of women per room, or women's satisfaction. In their comments, women described understaffed postnatal wards, early discharge and highlighted the importance of breastfeeding support, and concerns about long-term consequences such as postpartum depression., Conclusions: In the second year of the pandemic, WHO Standard-based quality measures related to breastfeeding improved for women giving birth in Norway compared to the first year of the pandemic. Women's general satisfaction with care during COVID-19 did however not improve significantly from 2020 to 2021. Compared to pre-pandemic data, our findings suggest an initial decrease in exclusive breastfeeding at discharge during the COVID-19 pandemic in Norway with little difference comparing 2020 versus 2021. Our findings should alert researchers, policy makers and clinicians in postnatal care services to improve future practices., (© 2023. The Author(s).)

Introduction: The COVID-19 pandemic may increase women's vulnerability through violations of their integrity during birth. In a cross-sectional study (March 2020 to March 2022), we investigated how women giving birth experienced maternity care during the pandemic in Germany and which factors were associated with their birth integrity., Methods: In a survey (validated questionnaire and two open-ended questions), women ≥ 18 years described their experiences of maternity care. We conducted quantitative analyses using descriptive statistics and logistic regressions to investigate factors associated with dignified care and emotional support, which are understood as proxies of birth integrity. We analysed the open-ended questions through inductive content analysis., Results: We included data from 1271 participants and 214 comments. The majority of respondents felt emotionally supported (71%) and treated with dignity (76%). One third reported not always being involved in decision-making, while 14% felt they were subjected to physical, verbal or emotional abuse. For 57% of women, their companion of choice was absent or their presence limited. Those factors were all associated with the chances of feeling treated with dignity and emotionally supported. The qualitative comments provided an insight into what specifically women perceive as violating their integrity., Discussion: During the COVID-19 pandemic, the vulnerability of parturients lies in the violation of their birth integrity. Measures to promote respectful maternity care of women who give birth include comprehensive structural and political solutions as well as further research on the determinants of birth integrity., (© 2023. The Author(s).)

Background: Exclusive breastfeeding is the optimal infant nutrition, providing infants immunoprotection against many diseases including SARS-CoV-2 infection. Restrictions during the COVID-19 pandemic may have negatively affected breastfeeding practices in maternity care facilities. The aims of the study were to examine exclusive breastfeeding rates at discharge over time and to identify factors associated with exclusive breastfeeding during the pandemic., Methods: A cross-sectional survey was conducted among mothers who gave birth in a maternity care facility in the World Health Organization (WHO) European Region countries during the COVID-19 pandemic. The socio-ecological model was employed to examine intrapersonal, interpersonal, organizational, and community/society factors associated with maternal report of exclusive breastfeeding at the time of discharge., Results: There were 26,709 participating mothers from 17 European Region countries who were included in the analysis. Among the mothers, 72.4% (n = 19,350) exclusively breastfed and 27.6% (n = 7,359) did not exclusively breastfeed at discharge. There was an overall decline in exclusive breastfeeding rates over time (p = 0.015) with a significantly lower rate following the publication of the WHO breastfeeding guidelines on 23 June 2020 (AOR 0.88; 95% CI 0.82, 0.94). Factors significantly associated with exclusive breastfeeding outcomes in the logistic regression analysis included maternal age, parity, education, health insurance, mode of birth, inadequate breastfeeding support, lack of early breastfeeding initiation, lack of full rooming-in, birth attendant, perceived healthcare professionalism and attention, facility room cleanliness, timing of birth, and location of birth., Conclusions: Results from the study indicate the decline in exclusive breastfeeding rates in the WHO European Region during the COVID-19 pandemic. Using the socio-ecological model to identify factors associated with breastfeeding outcomes facilitates an integrated and holistic approach to address breastfeeding needs among women across the region. These findings demonstrate the need to augment breastfeeding support and to protect exclusive breastfeeding among mother-infant dyads, in an effort to reverse the declining exclusive breastfeeding rates. The study highlights the need to educate mothers and their families about the importance of exclusive breastfeeding, reduce maternal-infant separation, increase professional breastfeeding support, and follow evidence-based practice guidelines to promote breastfeeding in a comprehensive and multi-level manner., Trial Registration Number: Clinical Trials NCT04847336., (© 2022. The Author(s).)

Objective: To describe the perception of quality of maternal and newborn care (QMNC) around the time of childbirth among migrant and nonmigrant women in Europe., Methods: Women who gave birth at a health facility in 11 countries of the WHO European Region from March 2020 to July 2021 were invited to answer an online questionnaire including demographics and childbirth experience. Data were analyzed and compared for 1781 migrant and 20 653 nonmigrant women., Results: Migrant women who experienced labor perceived slightly more difficulties in attending routine antenatal visits (41.2% vs 39.4%; P = 0.001), more barriers in accessing facilities (32.9% vs 29.9%; P = 0.001), lack of timely care (14.7% vs 13.0%; P = 0.025), inadequate room comfort and equipment (9.2% vs 8.5%; P = 0.004), inadequate number of women per room (9.4% vs 8.6%; P = 0.039), being prevented from staying with their baby as they wished (7.8% vs 6.9%; P = 0.011), or suffering abuse (14.5% vs 12.7%; P = 0.022) compared with nonmigrant women. For women who had a prelabor cesarean, migrant women were more likely not to receive pain relief after birth (16.8% vs.13.5%; P = 0.039) and less likely to provide informal payment (1.8% vs 4.4%; P = 0.005) compared with nonmigrant women. Overall, the QMNC index was not significantly different for migrant compared with nonmigrant women., Conclusion: Gaps in overall QMNC were reported by both migrant and nonmigrant women, with improvements to healthcare necessary for all., (© 2022 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Objective: To investigate the quality of maternal and newborn care (QMNC) during childbirth in Luxembourg from women's perspectives., Methods: Women giving birth in facilities in Luxembourg between March 1, 2020, and July 1, 2021, answered a validated online WHO standards-based questionnaire as part of the multicountry IMAgINE EURO study. Descriptive and multivariate quantile regression analyses were performed., Results: A total of 493 women were included, representing 5.2% of women giving birth in the four maternity hospitals in Luxembourg during the study period. Most quality measures suggested high QMNC, although specific gaps were observed: 13.4% (n = 66) of women reported not being treated with dignity, 9.1% (n = 45) experienced abuse, 42.9% (n = 30) were not asked for consent prior to instrumental vaginal birth, 39.3% (n = 118) could not choose their birth position, 27% (n = 133) did not exclusively breastfeed at discharge (without significant differences over time), 20.5% (n = 101) reported an insufficient number of healthcare professionals, 20% (n = 25) did not receive information on the newborn after cesarean, and 41.2% (n = 203) reported lack of information on newborn danger signs before discharge. Multivariate analyses highlighted higher reported QMNC indexes among women born outside Luxembourg and delivering with a gynecologist, and significantly lower QMNC indexes in women with the highest education levels and those delivering in the hospital offering some private services., Conclusions: Despite maternal reports suggesting an overall high QMNC in Luxembourg, improvements are needed in specific aspects of care and communication, mostly related to maternal autonomy, respect, and support, but also number and competencies of the health workforce., (© 2022 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Objective: To assess the quality of maternal and newborn care (QMNC) in countries of the former Yugoslavia., Method: Women giving birth in a facility in Slovenia, Croatia, Serbia, and Bosnia-Herzegovina between March 1, 2020 and July 1, 2021 answered an online questionnaire including 40 WHO standards-based quality measures., Results: A total of 4817 women were included in the analysis. Significant differences were observed across countries. Among those experiencing labor, 47.4%-62.3% of women perceived a reduction in QMNC due to the COVID-19 pandemic, 40.1%-69.7% experienced difficulties in accessing routine antenatal care, 60.3%-98.1% were not allowed a companion of choice, 17.4%-39.2% reported that health workers were not always using personal protective equipment, and 21.2%-53.8% rated the number of health workers as insufficient. Episiotomy was performed in 30.9%-62.8% of spontaneous vaginal births. Additionally, 22.6%-55.9% of women received inadequate breastfeeding support, 21.5%-62.8% reported not being treated with dignity, 11.0%-30.5% suffered abuse, and 0.7%-26.5% made informal payments. Multivariate analyses confirmed significant differences among countries, with Slovenia showing the highest QMNC index, followed by Croatia, Bosnia-Herzegovina, and Serbia., Conclusion: Differences in QMNC among the countries of the former Yugoslavia during the COVID-19 pandemic were significant. Activities to promote high-quality, evidence-based, respectful care for all mothers and newborns are urgently needed., Clinicaltrials: gov Identifier: NCT04847336., (© 2022 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)