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Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To identify and assess the effect of support interventions focused on psychological, social, and emotional outcomes for bereaved parents (including birth and non-birthing mothers, fathers, partners) and family members of parents (e.g. grandparents; siblings) who have experienced stillbirth or neonatal death., (Copyright © 2024 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Background: The implementation of the maternal perinatal death surveillance and response (MPDSR) policy is among the envisaged strategies to reduce the high global burden of maternal and perinatal mortality and morbidity. However, implementation of this policy across various contexts is inconsistent. Theoretically informed approaches to process evaluation can support assessment the implementation of policy interventions such as MPDSR, particularly in understanding what the actors involved actually do. In this article, we reflect on how the normalisation process theory (NPT) was used to explore implementation of the MPDSR policy in Uganda. NPT is a sociological theory concerned with the social organisation of the work (implementation) of making practices routine elements of everyday life (embedding) and of sustaining embedded practices in their social contexts (integration)., Methods: This qualitative multiple case study conducted across eight districts in Uganda and among 10 health facilities (cases) representing four out of the seven levels of the Uganda health care system. NPT was utilised in several ways including informing the study design, structuring the data collection tools (semi-structured interview guides), providing an organising framework for analysis, interpreting and reporting of study findings as well as making recommendations. Study participants were purposely selected to reflect the range of actors involved in the policy implementation process. This included direct care providers located at each of the cases, the Ministry of Health and from agencies and professional associations. Data were collected using semi-structured, in-depth interviews and were inductively and deductively analysed using NPT constructs and subconstructs., Results and Conclusion: NPT served useful for process evaluation, particularly in identifying factors that contribute to variations in policy implementation. Considering the NPT focus on the agency of people involved in implementation, additional efforts are required to understand how recipients of the policy intervention influence how the intervention becomes embedded within the various contexts., (© 2024. The Author(s).)

Introduction: The present study was conducted with the aim of evaluating the accuracy of International Classification of Disease Perinatal Mortality (ICD-PM) codes assigned on death certificates before and after an expert panel review., Method: The present study was a mixed methods observational study conducted at Umm al-Benin Hospital, the sole specialized obstetrics and gynecology center affiliated with Mashhad University of Medical Sciences. The study comprised three distinct stages: (1) Collecting primary ICD-PM codes assigned to perinatal death certificates, along with other relevant information, from October 2021 to March 2022; (2) Examining the circumstances of each perinatal death case and re-identifying the causes of death through a consensus process involving a panel of experts comprising pediatricians, obstetrics and gynecology specialists, and nursing and midwifery experts; presenting the new ICD-PM code; (3) Comparing the ICD-PM codes assigned to perinatal death certificates before and after the expert panel's evaluation., Result: During the study period, a total of seven specialized panels were conducted to examine perinatal deaths. Out of the 71 cases, 41 were carefully reviewed by experts. These cases included 32 stillbirths and nine neonatal deaths. The examination process followed specific inclusion and exclusion criteria. The findings revealed that there were no significant changes in the causes of neonatal deaths. However, it was notable that 80% of the previously unknown causes of stillbirths were successfully identified. Notably, the occurrence of stillbirths increased by 78% due to maternal causes and conditions., Conclusion: Convening panels of experts to discuss the causes of perinatal deaths can effectively reduce the percentage of unknown causes, as classified by ICD-PM. This approach also guarantees the availability of essential data for implementing effective interventions to decrease preventable perinatal deaths., (© 2024. The Author(s).)

Historically, countries have primarily relied on policy rather than legislation to implement Maternal and Perinatal Death Surveillance and Response systems (MPDSR). However, evidence shows significant disparities in how MPDSR is implemented among different countries. In this article, we argue for the importance of establishing MPDSR systems mandated by law and aligned with the country's constitutional provisions, regional and international human rights obligations, and public health commitments. We highlight how a "no blame" approach can be regulated to provide a balance between confidentiality of the system and access to justice and remedies., (© 2024 The Author(s). International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Context: The Qualineo Strategy is an effective measure for reducing neonatal mortality in regions with the highest death rates. In addition, it is a relevant Brazilian tool for strengthening teamwork and neonatal assistance. This study aims to analyze the predictors of neonatal death in the indicators of care provided by the Qualineo Strategy at a reference maternity hospital in Piauí, in the years 2021 to 2022., Methods: This is a retrospective study of 1856 newborn records. Pearson's chi-squared test was used to assess the association between the variables; a predictive regression model was used to identify the variables that predict neonatal mortality., Results: There was a significant association between all neonatal variables and the outcome of death ( p < 0.05). The predictor variables for death in term newborns were the use of drugs by the mother and admission to the Neonatal Intensive Care Unit. For premature newborns, the predictor variables were, as follows: the use of cannula ventilation, an Apgar score in the 1st minute <7; and admission to the Neonatal Intensive Care Unit., Conclusions: The results will make it possible to visualize better strategies for the reality analyzed and reinforce the importance of prenatal care.

Background: The global population impacted by humanitarian crises continues to break records each year, leaving strained and fractured health systems reliant upon humanitarian assistance in more than 60 countries. Yet little is known about implementation of maternal and perinatal death surveillance and response (MPDSR) within crisis-affected contexts. This scoping review aimed to synthesise evidence on the implementation of MPDSR and related death review interventions in humanitarian settings., Methods: We searched for peer-reviewed and grey literature in English and French published in 2016-22 that reported on MPDSR and related death review interventions within humanitarian settings. We screened and reviewed 1405 records, among which we identified 25 peer-reviewed articles and 11 reports. We then used content and thematic analysis to understand the adoption, appropriateness, fidelity, penetration, and sustainability of these interventions., Results: Across the 36 records, 33 unique programmes reported on 37 interventions within humanitarian contexts in 27 countries, representing 69% of the countries with a 2023 United Nations humanitarian appeal. Most identified programmes focussed on maternal death interventions; were in the pilot or early-mid implementation phases (1-5 years); and had limited integration within health systems. While we identified substantive documentation of MPDSR and related death review interventions, extensive gaps in evidence remain pertaining to the adoption, fidelity, penetration, and sustainability of these interventions. Across humanitarian contexts, implementation was influenced by severe resource limitations, variable leadership, pervasive blame culture, and mistrust within communities., Conclusions: Emergent MPDSR implementation dynamics show a complex interplay between humanitarian actors, communities, and health systems, worthy of in-depth investigation. Future mixed methods research evaluating the gamut of identified MPDSR programmes in humanitarian contexts will greatly bolster the evidence base. Investment in comparative health systems research to understand how best to adapt MPDSR and related death review interventions to humanitarian contexts is a crucial next step., 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 © 2024 by the Journal of Global Health. All rights reserved.)

Birth defect and perinatal death are major public issues threatening the health of women and children in China. However, perinatal death attributed to birth defects has not yet received sufficient attention. To minimize the occurrence of perinatal death caused by birth defects, this review article deeply analyzed the current status of epidemiology, clinical, and basic research on perinatal death attributed to birth defects both domestically and internationally, and proposed to encourage the conduct of national research on perinatal causes. We should also pay attention to the application of the perinatal cause of death classification system, and focus on accurate diagnosis and the three-level prevention and control of perinatal death attributed to birth defect.

Maternal and/or perinatal death review or audits aim to improve the quality of health services and reduce deaths due to causes identified. A death review audit cycle identifies causes of deaths and possible modifiable factors, these can point to potential breaks in the continuity of health care and other health systems faults and challenges. It is an important function of audit cycles to develop, implement, monitor, and review action plans to improve the service. The WHO has produced two handbooks (Making Every Baby Count and Monitoring Emergency Obstetric Care) to guide maternal and perinatal death reviews. Health worker related factors accounts for two thirds of aspects that, if done differently may have prevented the adverse outcome. This emphasises the need for skilled health care workers at every delivery and for deliveries to take place in health facilities., Competing Interests: Declaration of competing interest The authors have no conflicts of interest., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Maternal and Perinatal Death Surveillance and Review (MPDSR) can reduce mortality but its implementation is often suboptimal, especially in low- and middle-income countries (LMICs)., Objectives: To understand the determinants of behaviors influencing implementation of MPDSR in LMICs (through a systematic review of qualitative studies), in order to plan an intervention to improve its implementation., Search Strategy: Terms for maternal or perinatal death reviews and qualitative studies., Selection Criteria: Qualitative studies regarding implementation of MPDSR in LMICs., Data Collection and Analysis: We coded the included studies using the Theoretical Domains Framework and COM-B model of behavior change (Capability, Opportunity, Motivation). We developed guiding principles for interventions to improve implementation of MPDSR., Main Results: Fifty-nine studies met our inclusion criteria. Capabilities required to conduct MPDSR (knowledge and technical/leadership skills) increase cumulatively from community to health facility and leadership levels. Physical and social opportunities depend on adequate data, human and financial resources, and a blame-free environment. All stakeholders were motivated to avoid negative consequences (blame, litigation, disciplinary action)., Conclusions: Implementation of MPDSR could be improved by (1) introducing structural changes to reduce negative consequences, (2) strengthening data collection tools and information systems, (3) mobilizing adequate resources, and (4) building capabilities of all stakeholders., (© 2023 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Background: This is a follow-up study to the pentaerythrityl tetranitrate randomized controlled multicenter trial that reports neonatal outcome data of newborns admitted to neonatal intensive care units and outcome data of the offspring at 12 months of age., Objective: We present data on adverse events reported during the study to document the safety of pentaerythrityl tetranitrate treatment during pregnancy. To further evaluate the effects of pentaerythrityl tetranitrate on neonatal and long-term outcomes, we present follow up data from of 240 children at 12 months of age, including information on height, weight, head circumference, developmental milestones, and the presence of chronic disease and of 144 newborns admitted to the neonatal intensive care unit during the trial., Study Design: The pentaerythrityl tetranitrate trial was a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of the nitric oxide-donor pentaerythrityl tetranitrate in the prevention of fetal growth restriction and perinatal death in pregnancies complicated by abnormal placental perfusion., Results: Results at 12 months demonstrated that significantly more children were age appropriately developed without impairments in the pentaerythrityl tetranitrate group (P=.018). In addition, the presence of chronic disease was lower in the pentaerythrityl tetranitrate group (P=.041). Outcome data of the 144 newborns admitted to the neonatal intensive care unit did not reveal differences between the treatment and placebo groups. There were no differences in the number or nature of reported adverse events between the study groups., Conclusion: The analysis shows that study children born in the pentaerythrityl tetranitrate cohort have a clear advantage compared with the placebo group at the age of 12 months, as evidenced by the increased incidence of normal development without the presence of chronic disease. Although safety has been proven, further follow-up studies are necessary to justify pentaerythrityl tetranitrate treatment during pregnancies complicated by impaired uterine perfusion., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Introduction: Reducing preventable perinatal deaths is the focus of perinatal death surveillance and response programmes. Standardised review tools can help identify modifiable factors in perinatal deaths., Aim: This systematic review aimed to identify, compare, and appraise perinatal mortality review tools (PMRTs) in upper-middle to high-income countries., Methods: Four major scientific databases were searched for publications relating to perinatal death reviews. There were no restrictions on date, study, or publication type. Professional websites for each country were searched for relevant material. The Appraisal of Guidelines Research and Evaluation Health Systems (AGREE-HS) checklist was used for quality appraisal of each tool. A narrative synthesis was used to describe and compare tools., Findings: Ten PMRTs were included. Five PMRTs were from high-income countries, four from upper-middle income countries and one was designed for use in a global context. The structure, content, and quality of each PMRT varied. Each tool collected information about the antepartum, intrapartum, and neonatal periods and a section to classify perinatal deaths using a standardised classification system. All tools reviewed the care provided. Five tools included recommendation development for changes to clinical care. Four tools mentioned parent involvement in the review process. For quality appraisal, one review tool scored "high quality", six scored "moderate quality" and two scored "poor quality"., Conclusion: There is little standardisation when it comes to PMRTs. Guidance on structuring PMRTs in a standardised way is needed. Recommendation development from a review is important to highlight changes to care required to reduce preventable perinatal deaths., Competing Interests: Conflict of Interest The authors do not have any conflicting interests to disclose., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Perinatal death, a global health problem, can be prevented with simple resuscitation interventions that help the baby breathe immediately at birth. Latter-day Saint Charities (LDSC) and Safa Sunaulo Nepal (SSN) implemented a program to scale-up Helping Babies Breathe (HBB) training in Karnali Province, Nepal from January 2020-February 2021. The interventions were implemented using a hybrid approach with on-site mentoring in the pre/post COVID period combined with remote support and monitoring during the COVID period. This paper reports overall changes in newborn outcomes in relation to the unique implementation approach used. A prospective cohort design was used to compare outcomes of birth cohorts in 16 public health facilities in the first and last three months of program implementation. Results showed significant decreases in intrapartum stillbirths (23%), and neonatal deaths within (27%) and after (41.3%) 24 hours of life. The scale-up of HBB training resulted in 557 providers receiving training and mentoring support during the program period, half trained during the COVID period. Increased practice sessions, review meetings and debriefing meetings were reported during the COVID period compared to pre/post COVID period. The evaluation is suggestive of the potential of a hybrid approach for improved perinatal outcomes and scaling-up of newborn resuscitation trainings in health system facing disruptions.

Background:  Neonatal deaths (NNDs) are a global public health challenge, predominantly affecting low- and middle-income countries. The causes of most NNDs are preventable. Therefore, this study reviewed perinatal clinical audit data at Kgapane Hospital over a 4-year period with a special focus on the factors associated with NNDs., Methods:  File audits were performed for all NNDs occurring at Kgapane Hospital and its catchment area from 2018 to 2021. The data from these audits were analysed to identify factors associated with NNDs., Results:  The NND rate for the study period was 12.6/1000 live births. In this study (n = 236), 90% of the deaths could be associated with four factors, namely prematurity (44%); intrapartum complications (19%) including asphyxia, meconium aspiration and breech deliveries; neonatal infections (16%) of which human immunodeficiency virus (HIV) positivity was the most prevalent; and foetal congenital abnormalities (11%). The modifiable factors included inadequate intrapartum foetal monitoring; delays in management interventions; instances where no attempts were made to refer patients for specialised care, or where no beds were available at the next level of care; patient-related factors; and inadequate adherence to management protocols, such as for the management of prematurity and HIV., Conclusion:  Understanding factors associated with NNDs can guide health worker training and improvement strategies to reduce this heart-breaking complication of pregnancy.Contribution: Family physicians working in rural hospitals are also responsible for newborn care. Understanding the factors associated with NNDs will guide them to focus training and develop improvement strategies to reduce these preventable deaths.

Background: Reduction of Tanzania's neonatal mortality rate has lagged behind that for all under-fives, and perinatal mortality has remained stagnant over the past two decades. We conducted a national verbal and social autopsy (VASA) study to estimate the causes and social determinants of stillbirths and neonatal deaths with the aim of identifying relevant health care and social interventions., Methods: A VASA interview was conducted of all stillbirths and neonatal deaths in the prior 5 years identified by the 2015-16 Tanzania Demographic and Health Survey. We evaluated associations of maternal complications with antepartum and intrapartum stillbirth and leading causes of neonatal death; conducted descriptive analyses of antenatal (ANC) and delivery care and mothers' careseeking for complications; and developed logistic regression models to examine factors associated with delivery place and mode., Results: There were 204 stillbirths, with 185 able to be classified as antepartum (88 [47.5%]) or intrapartum (97 [52.5%]), and 228 neonatal deaths. Women with an intrapartum stillbirth were 6.5% (adjusted odds ratio (aOR) = 1.065, 95% confidence interval (CI) 1.002, 1.132) more likely to have a C-section for every additional hour before delivery after reaching the birth attendant. Antepartum hemorrhage (APH), maternal anemia, and premature rupture of membranes (PROM) were significantly positively associated with early neonatal mortality due to preterm delivery, intrapartum-related events and serious infection, respectively. While half to two-thirds of mothers made four or more ANC visits (ANC4+), a third or fewer received quality ANC (Q-ANC). Women with a complication were more likely to deliver at hospital only if they received Q-ANC (neonates: aOR = 4.5, 95% CI 1.6, 12.3) or ANC4+ (stillbirths: aOR = 11.8, 95% CI 3.6, 38.0). Nevertheless, urban residence was the strongest predictor of hospital delivery., Conclusions: While Q-ANC and ANC4 + boosted hospital delivery among women with a complication, attendance was low and the quality of care is critical. Quality improvement efforts in urban and rural areas should focus on early detection and management of APH, maternal anemia, PROM, and prolonged labor, and on newborn resuscitation., (© 2023. The Author(s).)

Background: Neonatal deaths remain a serious public health concern in Ethiopia; being one of the top five countries contributing to half of the neonatal deaths worldwide. Although antenatal care (ANC) is assumed as one of the viable options that contribute to neonatal survival, findings from original studies indicated disparities in the effect of ANC on neonatal mortality. Thus, this review aimed to determine the pooled effect of ANC on neonatal mortality in Ethiopia., Methods: Databases such as PubMed, EMBASE, CINAHL, HINARI, and Cochrane Central Library were searched for articles using keywords. Selection of eligible articles and data extraction were conducted by an independent author. The risk of a bias assessment tool for non-randomized studies was used to assess the quality of the articles. Comprehensive meta-analysis version 2 software was used for meta-analysis. Heterogeneity and publication bias of included studies were assessed using I 2 test statistic and Egger test, respectively. The random-effect model was employed; an outcome is reported using a risk ratio with a 95% confidence interval., Results: Of 28 included studies, 20 showed receiving at least one ANC visit had a significant association with neonatal mortality. Accordingly, the estimated pooled risk ratio for neonatal mortality was 0.59 (95% CI 0.45, 0.77) among infants born to women who had at least one ANC visit compared to infants born to women who had no ANC visits., Conclusion: This finding indicated that neonatal mortality was decreased among infants born to women who had at least one ANC visit compared to infants born to women who had no ANC visit. Therefore, promoting and strengthening ANC service utilization during pregnancy would accelerate the reduction of neonatal mortality in Ethiopia., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Neonatal near-miss (NNM) can be considered as an end of a spectrum that includes stillbirths and neonatal deaths. Clinical audits of NNM might reduce perinatal adverse outcomes. The aim of this review is to evaluate the effectiveness of NNM audits for reducing perinatal mortality and morbidity and explore related contextual factors., Methods: PubMed, Embase, Scopus, CINAHL, LILACS and SciELO were searched in February/2023. Randomized and observational studies of NNM clinical audits were included without restrictions on setting, publication date or language., Primary Outcomes: perinatal mortality, morbidity and NNM., Secondary Outcomes: factors contributing to NNM and measures of quality of care. Study characteristics, methodological quality and outcome were extracted and assessed by two independent reviewers. Narrative synthesis was performed., Results: Of 3081 titles and abstracts screened, 36 articles had full-text review. Two studies identified, rated, and classified contributing care factors and generated recommendations to improve the quality of care. No study reported the primary outcomes for the review (change in perinatal mortality, morbidity and NNM rates resulting from an audit process), thus precluding meta-analysis. Three studies were multidisciplinary NNM audits and were assessed for additional contextual factors., Conclusion: There was little data available to determine the effectiveness of clinical audits of NNM. While trials randomised at patient level to test our research question would be difficult or unethical for both NNM and perinatal death audits, other strategies such as large, well-designed before-and-after studies within services or comparisons between services could contribute evidence. This review supports a Call to Action for NNM audits. Adoption of formal audit methodology, standardised NNM definitions, evaluation of parent's engagement and measurement of the effectiveness of quality improvement cycles for improving outcomes are needed., (© 2023. The Author(s).)

Background: Pre-eclampsia is a leading cause of maternal and perinatal mortality. Evidence regarding interventions in a low-income or middle-income setting is scarce. We aimed to evaluate whether planned delivery between 34 + 0 and 36 + 6 weeks' gestation can reduce maternal mortality and morbidity without increasing perinatal complications in India and Zambia., Methods: In this parallel-group, multicentre, open-label, randomised controlled trial, we compared planned delivery versus expectant management in women with pre-eclampsia from 34 + 0 to 36 + 6 weeks' gestation. Participants were recruited from nine hospitals and referral facilities in India and Zambia and randomly assigned to planned delivery or expectant management in a 1:1 ratio by a secure web-based randomisation facility hosted by MedSciNet. Randomisation was stratified by centre and minimised by parity, single-fetus pregnancy or multi-fetal pregnancy, and gestational age. The primary maternal outcome was a composite of maternal mortality or morbidity with a superiority hypothesis. The primary perinatal outcome was a composite of one or more of: stillbirth, neonatal death, or neonatal unit admission of more than 48 h with a non-inferiority hypothesis (margin of 10% difference). Analyses were by intention to treat, with an additional per-protocol analysis for the perinatal outcome. The trial was prospectively registered with ISRCTN, 10672137. The trial is closed to recruitment and all follow-up has been completed., Findings: Between Dec 19, 2019, and March 31, 2022, 565 women were enrolled. 284 women (282 women and 301 babies analysed) were allocated to planned delivery and 281 women (280 women and 300 babies analysed) were allocated to expectant management. The incidence of the primary maternal outcome was not significantly different in the planned delivery group (154 [55%]) compared with the expectant management group (168 [60%]; adjusted risk ratio [RR] 0·91, 95% CI 0·79 to 1·05). The incidence of the primary perinatal outcome by intention to treat was non-inferior in the planned delivery group (58 [19%]) compared with the expectant management group (67 [22%]; adjusted risk difference -3·39%, 90% CI -8·67 to 1·90; non-inferiority p<0·0001). The results from the per-protocol analysis were similar. There was a significant reduction in severe maternal hypertension (adjusted RR 0·83, 95% CI 0·70 to 0·99) and stillbirth (0·25, 0·07 to 0·87) associated with planned delivery. There were 12 serious adverse events in the planned delivery group and 21 in the expectant management group., Interpretation: Clinicians can safely offer planned delivery to women with late preterm pre-eclampsia, in a low-income or middle-income country. Planned delivery reduces stillbirth, with no increase in neonatal unit admissions or neonatal morbidity and reduces the risk of severe maternal hypertension. Planned delivery from 34 weeks' gestation should therefore be considered as an intervention to reduce pre-eclampsia associated mortality and morbidity in these settings., Funding: UK Medical Research Council and Indian Department of Biotechnology., Competing Interests: Declaration of interests JS is a National Institute for Health Research (NIHR) Senior Investigator and is supported by the NIHR Applied Research Collaboration South London at King's College Hospital NHS Foundation Trust. All other authors declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Importance: A short cervix as assessed by transvaginal ultrasound is an established risk factor for preterm birth. Study findings for a cervical pessary to prevent preterm delivery in singleton pregnancies with transvaginal ultrasound evidence of a short cervix have been conflicting., Objective: To determine if cervical pessary placement decreases the risk of preterm birth or fetal death prior to 37 weeks among individuals with a short cervix., Design, Setting, and Participants: We performed a multicenter, randomized, unmasked trial comparing a cervical pessary vs usual care from February 2017 through November 5, 2021, at 12 centers in the US. Study participants were nonlaboring individuals with a singleton pregnancy and a transvaginal ultrasound cervical length of 20 mm or less at gestations of 16 weeks 0 days through 23 weeks 6 days. Individuals with a prior spontaneous preterm birth were excluded., Interventions: Participants were randomized 1:1 to receive either a cervical pessary placed by a trained clinician (n = 280) or usual care (n = 264). Use of vaginal progesterone was at the discretion of treating clinicians., Main Outcome and Measures: The primary outcome was delivery or fetal death prior to 37 weeks., Results: A total of 544 participants (64%) of a planned sample size of 850 were enrolled in the study (mean age, 29.5 years [SD, 6 years]). Following the third interim analysis, study recruitment was stopped due to concern for fetal or neonatal/infant death as well as for futility. Baseline characteristics were balanced between participants randomized to pessary and those randomized to usual care; 98.9% received vaginal progesterone. In an as-randomized analysis, the primary outcome occurred in 127 participants (45.5%) randomized to pessary and 127 (45.6%) randomized to usual care (relative risk, 1.00; 95% CI, 0.83-1.20). Fetal or neonatal/infant death occurred in 13.3% of those randomized to receive a pessary and in 6.8% of those randomized to receive usual care (relative risk, 1.94; 95% CI, 1.13-3.32)., Conclusions and Relevance: Cervical pessary in nonlaboring individuals with a singleton gestation and with a cervical length of 20 mm or less did not decrease the risk of preterm birth and was associated with a higher rate of fetal or neonatal/infant mortality., Trial Registration: ClinicalTrials.gov Identifier: NCT02901626.

Background: Combined with perinatal mortality review, neonatal near-miss (NNM) audit has the potential to inform strategies to better prevent adverse perinatal outcomes. Nonetheless, there is lack of standardised definitions of NNM and limited evidence of implementation of NNM audits., Aim: To describe definitions of NNM and assess current approaches and attitudes toward perinatal mortality and morbidity audit., Materials and Methods: Online survey from December 2021 to February 2022, with a mix of Likert scales, polar, pool, multi-choice, and open-ended questions, disseminated through national and international organisations to perinatal healthcare workers from high-income countries., Results: One hundred and twenty participants came from Australia (n = 86), New Zealand (n = 18), Canada (n = 7), USA (n = 4), Netherlands (n = 2), other countries (n = 3). Neonatologists (35%), midwives (21.7%), obstetricians (12.5%), neonatal nurse practitioners (11.7%) and others (23.3%) responded. Most respondents thought the main characteristics to define NNM were birth asphyxia needing therapeutic hypothermia (68.3%), unexpected resuscitation at birth (67.5%), need for intubation/chest compression/adrenaline (65.0%) and metabolic acidosis at birth (60.0%). There were 97.5% of participants who considered NNM important for identifying cases for perinatal morbidity audits. However, only 10.0% of their institutions used a NNM definition. Overall, 98.4% of participants considered perinatal mortality and morbidity audits important to prevent adverse outcomes., Conclusion: Neonatal near-miss audit is viewed as a valuable tool to reduce adverse neonatal outcomes. There was reasonable consensus that NNM encompassed evidence of birth asphyxia and/or advanced neonatal resuscitation. Data from this international survey identifies a starting point for a consensus definition of NNM, which can be used for perinatal audits to identify opportunities for improvement., (© 2022 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology published by John Wiley & Sons Australia, Ltd on behalf of Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Background: The use of azithromycin reduces maternal infection in women during unplanned cesarean delivery, but its effect on those with planned vaginal delivery is unknown. Data are needed on whether an intrapartum oral dose of azithromycin would reduce maternal and offspring sepsis or death., Methods: In this multicountry, placebo-controlled, randomized trial, we assigned women who were in labor at 28 weeks' gestation or more and who were planning a vaginal delivery to receive a single 2-g oral dose of azithromycin or placebo. The two primary outcomes were a composite of maternal sepsis or death and a composite of stillbirth or neonatal death or sepsis. During an interim analysis, the data and safety monitoring committee recommended stopping the trial for maternal benefit., Results: A total of 29,278 women underwent randomization. The incidence of maternal sepsis or death was lower in the azithromycin group than in the placebo group (1.6% vs. 2.4%), with a relative risk of 0.67 (95% confidence interval [CI], 0.56 to 0.79; P<0.001), but the incidence of stillbirth or neonatal death or sepsis was similar (10.5% vs. 10.3%), with a relative risk of 1.02 (95% CI, 0.95 to 1.09; P = 0.56). The difference in the maternal primary outcome appeared to be driven mainly by the incidence of sepsis (1.5% in the azithromycin group and 2.3% in the placebo group), with a relative risk of 0.65 (95% CI, 0.55 to 0.77); the incidence of death from any cause was 0.1% in the two groups (relative risk, 1.23; 95% CI, 0.51 to 2.97). Neonatal sepsis occurred in 9.8% and 9.6% of the infants, respectively (relative risk, 1.03; 95% CI, 0.96 to 1.10). The incidence of stillbirth was 0.4% in the two groups (relative risk, 1.06; 95% CI, 0.74 to 1.53); neonatal death within 4 weeks after birth occurred in 1.5% in both groups (relative risk, 1.03; 95% CI, 0.86 to 1.24). Azithromycin was not associated with a higher incidence in adverse events., Conclusions: Among women planning a vaginal delivery, a single oral dose of azithromycin resulted in a significantly lower risk of maternal sepsis or death than placebo but had little effect on newborn sepsis or death. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; A-PLUS ClinicalTrials.gov number, NCT03871491.)., (Copyright © 2023 Massachusetts Medical Society.)

Background: Perinatal mortality (newborn deaths in the first week of life and stillbirths) continues to be a significant global health threat, particularly in resource-constrained settings. Low-tech, innovative solutions that close the quality-of-care gap may contribute to progress toward the Sustainable Development Goals for health by 2030. From 2012 to 2018, the Saving Mothers, Giving Life Initiative (SMGL) implemented the Birth weight and Age-at-Death Boxes for Intervention and Evaluation System (BABIES) matrix in Western Uganda. The BABIES matrix provides a simple, standardized way to track perinatal health outcomes to inform evidence-based quality improvement strategies., Methods: In November 2017, a facility-based qualitative evaluation was conducted using in-depth interviews with 29 health workers in 16 health facilities implementing BABIES in Uganda. Data were analyzed using directed content analysis across five domains: 1) perceived ease of use, 2) how the matrix was used, 3) changes in behavior or standard operating procedures after introduction, 4) perceived value of the matrix, and 5) program sustainability., Results: Values in the matrix were easy to calculate, but training was required to ensure correct data placement and interpretation. Displaying the matrix on a highly visible board in the maternity ward fostered a sense of accountability for health outcomes. BABIES matrix reports were compiled, reviewed, and responded to monthly by interprofessional teams, prompting collaboration across units to fill data gaps and support perinatal death reviews. Respondents reported improved staff communication and performance appraisal, community engagement, and ability to track and link clinical outcomes with actions. Midwives felt empowered to participate in the problem-solving process. Respondents were motivated to continue using BABIES, although sustainability concerns were raised due to funding and staff shortages., Conclusions: District-level health systems can use data compiled from the BABIES matrix to inform policy and guide implementation of community-centered health practices to improve perinatal heath. Future work may consider using the Conceptual Framework on Use of the BABIES Matrix for Perinatal Health as a model to operationalize concepts and test the impact of the tool over time., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Competing Interests: Competing interests: The authors completed the ICMJE Unified Competing Interest Form (available upon request from the corresponding author) and declare no conflicts of interest.

Introduction: The under-five mortality (U5M) trend in Malaysia significantly declined from 30.0 per 1000 live births (1980) to 8.0 per 1000 live births (2004), and the trend plateaued over the next two decades. Stillbirths and neonatal deaths were the major contributors to U5M. Scarce literature addressing factors associated with preventable U5M in Malaysia. The objective of this study was to describe preventable stillbirths and neonatal mortality, the associated factors and recommendation for improvement., Materials and Methods: The U5M surveillance data from 2015 to 2017 was retrieved for Malaysian cases of stillbirths and neonatal deaths with multiple pregnancies as exclusion. Stillbirth and neonatal death cases were analysed descriptively for socio-demographic and clinical characteristics. Logistic regressions were performed to identify the associated factors., Results: There were 15,444 cases selected for analysis, of which 55% of stillbirths and 45% of neonatal deaths. There were 21% of preventable deaths (U5M) and the major contributing causes of preventable stillbirths and neonatal deaths were classified as perinatal death (82.5%), infectious and parasitic diseases (4.1%) and congenital malformations (3.5%). The birth weight (aOR 6.03, 95% CI: 4.14-8.79), hypertensive mother (aOR 1.88, 95% CI: 1.66-2.12) and instrumental delivery (aOR 1.64, 95% CI: 1.16-2.31) were significantly associated with preventable stillbirths and neonatal deaths. Higher household income (>RM3000 per month) was noted as a protective factor (aOR 0.79, 95% CI:0.69,0.89). Mothers with ethnicities other thanBumiputera, single mothers and housewives were identified as the group of mothers with higher odds of poor perinatal services. Among the 3242 cases of preventable stillbirths and neonatal deaths with a complete documented level of adequacy and quality of healthcare, the most frequently identified factors were due to insufficient antenatal care (ANC) (20.4%), non-compliance with medical advice (12.3%) and unsuitable place of delivery (8.6%)., Conclusion: Increasing trend of preventable stillbirths and neonatal deaths was noted over 3 years (2015-2017), and one-fifth was related to insufficient ANC service-related factors. Remedial measures in improving the quality of ANC services with an emphasis on the targeted high-risk maternal socio-demographic group (other Bumiputera, older antenatal mothers, nonmarried, poor family income neglected family) and enhancing ANC competency skills among the healthcare provider through adequate training are required to decrease preventable stillbirths and neonatal deaths in Malaysia.

Background: A large proportion of early neonatal deaths occur at the time or on the first day of birth. The Preterm Birth Initiative East Africa (PTBi EA) set out to decrease mortality among preterm births through improving quality of facility-based intrapartum care. The PTBi EA cluster randomized trial's primary analysis showed the package reduced intrapartum stillbirth and neonatal death among preterm infants. This secondary analysis examines the impact of the PTBi intervention package on stillbirth and predischarge newborn deaths combined, among all births in 20 participating facilities in Kenya and Uganda., Methods: Eligible facilities were pair-matched and randomly assigned (1:1) into either the intervention or the control group. All facilities received support for data strengthening and a modified World Health Organization (WHO) Safe Childbirth Checklist; facilities in the intervention group additionally received provider mentoring using PRONTO simulation and team training as well as quality improvement collaboratives. We abstracted data from maternity registers., Results: Of the total 29 442 births that were included, Kenya had 8468 and 6465 births and Uganda had 8719 and 5790 births, in the control and intervention arms, respectively. There were 935 stillbirths and predischarge newborn deaths in the control arm and 439 in the intervention arm. The adjusted odds ratio (aOR) for the effect of the intervention on the combined outcome, among all births, was 0.96 (95% confidence interval (CI) = 0.69-1.32), which was different by country: Kenya - 1.12 (95% CI = 0.72-1.73); Uganda - 0.65 (95% CI = 0.44-0.98); P interaction  = 0.025. These trends were similar after excluding the PTBi primary cohort., Conclusions: The intervention package improved survival among all births in Uganda but not in Kenya. These results suggest the importance of context and facility differences that were observed between the two countries., Registration: This trial is registered with ClinicalTrials.gov, NCT03112018., Competing Interests: Disclosure of interest: The authors completed the ICMJE Disclosure of Interest Form (available upon request from the corresponding author) and declare that Dilys Walker is cofounder of PRONTO International. All other authors disclose no relevant interests., (Copyright © 2022 by the Journal of Global Health. All rights reserved.)

Background: Maternal and neonatal health are regarded as important indicators of health in most countries. Death auditing through, for example, the Maternal and Perinatal Death Surveillance and Response (MPDSR) is viewed as key to preventing maternal and newborn mortality. However, little is known about the implications of implementing perinatal auditing for healthcare professionals in low-income contexts. This study aimed to explore the ethical and practical consequences clinicians experience concerning MPDSR reporting practices in Ethiopia.  METHODS: Qualitative semi-structured in-depth individual interviews were conducted with 16 healthcare workers across professions at selected facilities in Ethiopia. The interview questions were related to clinicians' experiences with, and perceptions of, death auditing. Their strategies for coping with newborn losses and the related reporting practices were also explored. The material was analyzed following systematic text condensation, and the NVivo11 software was used for organizing and coding the data material., Results: Participants experienced fear of punishment and blame in relation to the perinatal death auditing process. They found that auditing did not contribute to reducing perinatal deaths and that their motivation to stick to the obligation was negatively affected by this. Performing audits without available resources to provide optimal care or support in the current system was perceived as unfair. Some hid information or misreported information in order to avoid accusations of misconduct when they felt they were not to blame for the baby's death. Coping strategies such as engaging in exceedingly larger work efforts, overtreating patients, or avoiding complicated medical cases were described., Conclusions: Experiencing perinatal death and death reporting constitutes a double burden for the involved healthcare workers. The preventability of perinatal death is perceived as context-dependent, and both clinicians and the healthcare system would benefit from a safe and blame-free reporting environment. To support these healthcare workers in a challenging clinical reality, guidelines and action plans that are specific to the Ethiopian context are needed., (© 2022. The Author(s).)

Background: Around 1 in 150 babies are stillborn or die in the first month of life in the UK. Most women conceive again, and subsequent pregnancies are often characterised by feelings of stress and anxiety, persisting beyond the birth. Psychological distress increases the risk of poor pregnancy outcomes and longer-term parenting difficulties. Appropriate emotional support in subsequent pregnancies is key to ensure the wellbeing of women and families. Substantial variability in existing care has been reported, including fragmentation and poor communication. A new care package improving midwifery continuity and access to emotional support during subsequent pregnancy could improve outcomes. However, no study has assessed the feasibility of a full-scale trial to test effectiveness in improving outcomes and cost-effectiveness for the National Health Service (NHS)., Methods: A prospective, mixed-methods pre-and post-cohort study, in two Northwest England Maternity Units. Thirty-eight women, (≤ 20 weeks' gestation, with a previous stillbirth, or neonatal death) were offered the study intervention (allocation of a named midwife care coordinator and access to group and online support). Sixteen women receiving usual care were recruited in the 6 months preceding implementation of the intervention. Outcome data were collected at 2 antenatal and 1 postnatal visit(s). Qualitative interviews captured experiences of care and research processes with women (n = 20), partners (n = 5), and midwives (n = 8)., Results: Overall recruitment was 90% of target, and 77% of women completed the study. A diverse sample reflected the local population, but non-English speaking was a barrier to participation. Study processes and data collection methods were acceptable. Those who received increased midwifery continuity valued the relationship with the care coordinator and perceived positive impacts on pregnancy experiences. However, the anticipated increase in antenatal continuity for direct midwife contacts was not observed for the intervention group. Take-up of in-person support groups was also limited., Conclusions: Women and partners welcomed the opportunity to participate in research. Continuity of midwifery care was supported as a beneficial strategy to improve care and support in pregnancy after the death of a baby by both parents and professionals. Important barriers to implementation included changes in leadership, service pressures and competing priorities., Trial Registration: ISRCTN17447733 first registration 13/02/2018., (© 2022. The Author(s).)

Objective: To evaluate the implementation of the maternal and neonatal death surveillance and response (MNDSR) system at county level in Liberia., Methods: Secondary analysis of data from a cross-sectional study carried out in March 2016, using both quantitative and qualitative methods to collect data in five counties based on set criteria. Three health facilities were selected in each county through the Health Management Information System (HMIS) by random sampling. The evaluation was also carried out in one catchment community per health facility and at the county referral hospital. Primary data were collected through individual interviews and a review of MNDSR tools and structure. Data were analyzed using thematic analysis., Results: Implementation of the MNDSR system was very low in the five counties. Only two out of the five counties were currently conducting MNDSR. MNDSR guidelines and standard operating procedures were not available at the county level. Only 12 (23.5%) health facilities had a maternal and neonatal death review committee. Less than a quarter of the assessed community members could correctly give the definition of a maternal or neonatal death., Conclusion: The MNDSR system is weak in Liberia, at county, health facility, and community levels. Strong national commitment is needed in collaboration with diverse partners for successful implementation of the system., (© 2022 International Federation of Gynecology and Obstetrics.)

Objective: To assess the implementation of the Maternal and Perinatal Death Surveillance and Response (MPDSR) strategy institutionalized in Benin in 2013 to address the alarmingly high maternal and neonatal death rates., Methods: A retrospective, mixed-methods study was performed. We used all maternal and neonatal death notifications and reviews from 2016 to 2018, reviewed the reports of 63 MPDSR working groups, and held two online group discussions. Descriptive quantitative analysis was performed, and content analysis was applied to qualitative data., Results: Deaths were under-notified, with estimated notification rates at 46%-48% for maternal and 16%-21% for neonatal deaths over the 3 years. Review completion rates were low, corresponding to 50%-56% of maternal and 8%-17% of neonatal deaths. Causes of undernotification included very low notification of community-based and private health facility deaths, and fear of blame. Low review completion rates were due to heavy workload, staffing shortages, fear of blame, and weak leadership. Moreover, reviews were of poor quality and the response was weak., Conclusion: Maternal and Perinatal Death Surveillance and Response is operational in Benin. However, this assessment highlights the need to strengthen the notification strategy, continuously build MPDSR committee members' capacities, engage decision-makers for an effective response, and create a better blame-free, accountable, and learning culture., (© 2021 International Federation of Gynecology and Obstetrics.)

Objective: To analyze implementation of maternal and neonatal death surveillance and response (MNDSR) in Cameroon to determine to what extent monitoring objectives are being met and highlight the main obstacles and facilitating factors., Methods: Secondary analysis of a cross-sectional study using a qualitative method and routine data on maternal health. Semistructured interviews were conducted with participants involved in MNDSR at the central, regional, and district levels., Results: Notification of maternal deaths has been incorporated into the Integrated Disease Surveillance and Response (IDSR) system since January 2014. However, maternal deaths are underreported in most hospitals and neonatal and community deaths are not recorded. Comprehensive review of maternal deaths does not occur in all hospitals despite training of providers in 2013 on how to conduct reviews., Conclusion: Implementation of MNDSR in Cameroon is insufficient. More commitment from the Ministry of Health is needed to develop an action plan and secure funding., (© 2022 International Federation of Gynecology and Obstetrics.)

Introduction: The high burden of stillbirths and neonatal deaths is driving global initiatives to improve birth outcomes. Discerning stillbirths from neonatal deaths can be difficult in some settings, yet this distinction is critical for understanding causes of perinatal deaths and improving resuscitation practices for live born babies., Methods: We evaluated data from the Child Health and Mortality Prevention Surveillance (CHAMPS) network to compare the accuracy of determining stillbirths versus neonatal deaths from different data sources and to evaluate evidence of resuscitation at delivery in accordance with World Health Organization (WHO) guidelines. CHAMPS works to identify causes of stillbirth and death in children <5 years of age in Bangladesh and 6 countries in sub-Saharan Africa. Using CHAMPS data, we compared the final classification of a case as a stillbirth or neonatal death as certified by the CHAMPS Determining Cause of Death (DeCoDe) panel to both the initial report of the case by the family member or healthcare worker at CHAMPS enrollment and the birth outcome as stillbirth or livebirth documented in the maternal health record., Results: Of 1967 deaths ultimately classified as stillbirth, only 28 (1.4%) were initially reported as livebirths. Of 845 cases classified as very early neonatal death, 33 (4%) were initially reported as stillbirth. Of 367 cases with post-mortem examination showing delivery weight >1000g and no maceration, the maternal clinical record documented that resuscitation was not performed in 161 cases (44%), performed in 14 (3%), and unknown or data missing for 192 (52%)., Conclusion: This analysis found that CHAMPS cases assigned as stillbirth or neonatal death after DeCoDe expert panel review were generally consistent with the initial report of the case as a stillbirth or neonatal death. Our findings suggest that more frequent use of resuscitation at delivery and improvements in documentation around events at birth could help improve perinatal outcomes., Competing Interests: The authors have declared that no competing interests exist.

Background: Worldwide, nifedipine and atosiban are the two most commonly used tocolytic agents for the treatment of threatened preterm birth. The aim of this study was to evaluate the effectiveness of nifedipine and atosiban in an individual participant data meta-analysis (IPDMA)., Methods: We investigated the occurrence of adverse neonatal outcomes in women with threatened preterm birth by performing an IPDMA, and sought to identify possible subgroups in which one treatment may be preferred. We searched PubMed, Embase, and Cochrane for trials comparing nifedipine and atosiban for treatment of threatened preterm birth between 24 0/7 and 34 0/7 weeks' gestational age. Primary outcome was a composite of perinatal mortality and neonatal morbidities including respiratory distress syndrome, intraventricular haemorrhage, periventricular leucomalacia, necrotising enterocolitis, and sepsis. Secondary outcomes included NICU admission, prolongation of pregnancy and GA at delivery. For studies that did not have the original databases available, metadata was used. This led to a two-stage meta-analysis that combined individual participant data with aggregate metadata., Results: We detected four studies (N = 791 women), of which two provided individual participant data (N = 650 women). The composite neonatal outcome occurred in 58/364 (16%) after nifedipine versus 69/359 (19%) after atosiban (OR 0.76, 95%CI 0.47-1.23). Perinatal death occurred in 14/392 (3.6%) after nifedipine versus 7/380 (1.8%) after atosiban (OR 2.0, 95%CI 0.80-5.1). Nifedipine results in longer prolongation of pregnancy, with a 18 days to delivery compared with 10 days for atosiban (HR 0.83 (96% CI 0.69-0.99)). NICU admission occurred less often after nifedipine (46%) than after atosiban (59%), (OR 0.32, 95%CI 0.14-0.75). The sensitivity analysis revealed no difference in prolongation of pregnancy for 48 hours (OR 1.0, 95% CI 0.73-1.4) or 7 days (OR 1.3, 95% CI 0.85-5.8) between nifedipine and atosiban. There was a non-significant higher neonatal mortality in the nifedipine-exposed group (OR 1.4, 95% CI 0.60-3.4)., Conclusions: In this IPDMA, we found no differences in composite outcome between nifedipine and atosiban in the treatment of threatened preterm birth. However, the non-significant higher mortality after administering nifedipine warrants further investigation of the use of nifedipine as a tocolytic drug., Study Registration: We conducted this study according to a prospectively prepared protocol, registered with PROSPERO (the International Prospective Register of Systematic Reviews) under CRD42016024244., (© 2022. The Author(s).)

Background: Stillbirth and neonatal death are devastating pregnancy outcomes with long-lasting psychosocial consequences for parents and families, and wide-ranging economic impacts on health systems and society. It is essential that parents and families have access to appropriate support, yet services are often limited. Internet-based programs may provide another option of psychosocial support for parents following the death of a baby. We aim to evaluate the efficacy and acceptability of a self-guided internet-based perinatal bereavement support program "Living with Loss" (LWL) in reducing psychological distress and improving the wellbeing of parents following stillbirth or neonatal death., Methods: This trial is a two-arm parallel group randomized controlled trial comparing the intervention arm (LWL) with a care as usual control arm (CAU). We anticipate recruiting 150 women and men across Australia who have experienced a stillbirth or neonatal death in the past 2 years. Participants randomized to the LWL group will receive the six-module internet-based program over 8 weeks including automated email notifications and reminders. Baseline, post-intervention, and 3-month follow-up assessments will be conducted to assess primary and secondary outcomes for both arms. The primary outcome will be the change in Kessler Psychological Distress Scale (K10) scores from baseline to 3-month follow-up. Secondary outcomes include perinatal grief, anxiety, depression, quality of life, program satisfaction and acceptability, and cost-effectiveness. Analysis will use intention-to-treat linear mixed models to examine psychological distress symptom scores at 3-month follow-up. Subgroup analyses by severity of symptoms at baseline will be undertaken., Discussion: The LWL program aims to provide an evidence-based accessible and flexible support option for bereaved parents following stillbirth or neonatal death. This may be particularly useful for parents and healthcare professionals residing in rural regions where services and supports are limited. This RCT seeks to provide evidence of the efficacy, acceptability, and cost-effectiveness of the LWL program and contribute to our understanding of the role digital services may play in addressing the gap in the availability of specific bereavement support resources for parents following the death of a baby, particularly for men., Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12621000631808 . Registered prospectively on 27 May 2021., (© 2022. The Author(s).)

Competing Interests: Competing interests: The authors completed the ICMJE Unified Competing Interest Form (available upon request from the corresponding author) and declare no conflicts of interest.

Introduction: Despite a strong evidence base for developing interventions to reduce child mortality and morbidity related to pregnancy and delivery, major knowledge-implementation gaps remain. The Action Leveraging Evidence to Reduce perinatal morTality and morbidity (ALERT) in sub-Saharan Africa project aims to overcome these gaps through strengthening the capacity of multidisciplinary teams that provide maternity care. The intervention includes competency-based midwife training, community engagement for study design, mentoring and quality improvement cycles. The realist process evaluation of ALERT aims at identifying and testing the causal pathway through which the intervention achieves its impact., Methods and Analysis: This realist process evaluation complements the effectiveness evaluation and the economic evaluation of the ALERT intervention. Following the realist evaluation cycle, we will first elicit the initial programme theory on the basis of the ALERT theory of change, a review of the evidence on adoption and diffusion of innovations and the perspectives of the stakeholders. Second, we will use a multiple embedded case study design to empirically test the initial programme theory in two hospitals in each of the four intervention countries. Qualitative and quantitative data will be collected, using in-depth interviews with hospital staff and mothers, observations, patient exit interviews and (hospital) document reviews. Analysis will be guided by the Intervention-Actors-Context-Mechanism-Outcome configuration heuristic. We will use thematic coding to analyse the qualitative data. The quantitative data will be analysed descriptively and integrated in the analysis using a retroductive approach. Each case study will end with a refined programme theory (in-case analysis). Third, we will carry out a cross-case comparison within and between the four countries. Comparison between study countries should enable identifying relevant context factors that influence effectiveness and implementation, leading to a mid-range theory that may inform the scaling up the intervention., Ethics and Dissemination: In developing this protocol, we paid specific attention to cultural sensitivity, the do no harm principle, confidentiality and non-attribution. We received ethical approval from the local and national institutional review boards in Tanzania, Uganda, Malawi, Benin, Sweden and Belgium. Written or verbal consent of respondents will be secured after explaining the purpose, potential benefits and potential harms of the study using an information sheet. The results will be disseminated through workshops with the hospital staff and national policymakers, and scientific publications and conferences., Trial Registration Number: PACTR202006793783148., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Objectives: To examine the association between antenatal corticosteroids (ACS) use and perinatal mortality in singletons and twins delivered before 35 weeks of gestation., Design: Secondary analysis of data from an observational prospective chart review study that investigated if exposure to ACS was associated with lower rates of perinatal mortality in preterm infants., Setting: This study was conducted in four hospitals located in Mwanza region, Tanzania., Participants: The study population included all preterm singletons and twins delivered at these hospitals between 24 weeks 0 days and 34 weeks 6 days of gestation from July 2019 to February 2020., Outcome Measures: The primary outcome was perinatal mortality; the secondary outcome was respiratory distress syndrome (RDS)., Results: The study included 844 singletons and 210 twin infants. Three hundred and fourteen singletons (37.2%) and 52 twins (24.8%) were exposed to at least one dose of ACS. Adjusted multivariate analyses revealed that among singletons' exposure to ACS was significantly associated with a lower likelihood of perinatal mortality, adjusted relative risk (aRR) 0.30 (95% CI 0.22 to 0.40) and RDS, aRR 0.92 (95% CI 0.87 to 0.97). In twin infants, exposure to ACS was associated with a reduced risk of RDS only, aRR 0.87 (95% CI 0.78 to 0.98)., Conclusion: The use of ACS between 24 weeks 0 days and 34 weeks 6 days of gestation in both singletons and twins in low-resource settings is associated with positive infant outcomes. No adverse effects were noted. Further research that examines the benefits of ACS for twin infants is needed., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The AFFIRM intervention aimed to reduce stillbirth and neonatal deaths by increasing awareness of reduced fetal movements (RFM) and implementing a care pathway when women present with RFM. Although there is uncertainty regarding the clinical effectiveness of the intervention, the aim of this analysis was to evaluate the cost-effectiveness., Methods: A stepped-wedge, cluster-randomised trial was conducted in thirty-three hospitals in the United Kingdom (UK) and Ireland. All women giving birth at the study sites during the analysis period were included in the study. The costs associated with implementing the intervention were estimated from audits of RFM attendances and electronic healthcare records. Trial data were used to estimate a cost per stillbirth prevented was for AFFIRM versus standard care. A decision analytic model was used to estimate the costs and number of perinatal deaths (stillbirths + early neonatal deaths) prevented if AFFIRM were rolled out across Great Britain for one year. Key assumptions were explored in sensitivity analyses., Results: Direct costs to implement AFFIRM were an estimated £95,126 per 1,000 births. Compared to standard care, the cost per stillbirth prevented was estimated to be between £86,478 and being dominated (higher costs, no benefit). The estimated healthcare budget impact of implementing AFFIRM across Great Britain was a cost increase of £61,851,400/year., Conclusions: Perinatal deaths are relatively rare events in the UK which can increase uncertainty in economic evaluations. This evaluation estimated a plausible range of costs to prevent baby deaths which can inform policy decisions in maternity services., Trial Registration: The trial was registered with www., Clinicaltrials: gov , number NCT01777022 ., (© 2022. The Author(s).)

Objectives: Perinatal bereavement care is a complex area of practice. The COVID-19 pandemic led to reconfiguration of maternity and perinatal bereavement care services. This study explores Australian health care providers' perspectives of the impact of COVID-19 on the provision of respectful and supportive care following stillbirth or neonatal death., Methods: Members of a perinatal bereavement care network were consulted at the commencement of the pandemic in Australia using an online feedback form. Respondents provided ratings and free-text comments on the impact of COVID-19 on implementation of 49 recommendations contained in the Perinatal Society of Australia and New Zealand/Stillbirth Centre of Research Clinical Practice Guideline for Respectful and Supportive Perinatal Bereavement Care ., Results: Responses were received from 35 health care providers who provided perinatal bereavement care in clinical settings or through support organisations in Australia. Major impacts of COVID-19 were reported for 8 of 49 guideline recommendations. Impacts included reduced: support for mothers due to visitor restrictions; availability of cultural and spiritual support and interpreters; involvement of support people in decision-making; options for memory-making and commemorative rituals; and staff training and supervision. Adaptations to minimise impacts included virtual consultations, online staff training, use of cold cots, and increased staff support for memory-making., Conclusions: Health care providers encounter substantial challenges as they strive to implement best practice perinatal bereavement care in pandemic conditions. Some practice adaptations developed during the COVID-19 pandemic could benefit parents; however, evaluation of their effectiveness and acceptability is needed., (© 2022 Frances M. Boyle et al., published by De Gruyter, Berlin/Boston.)

Objective: Stillbirth is a potentially preventable complication of pregnancy. Identifying women at high risk of stillbirth can guide decisions on the need for closer surveillance and timing of delivery in order to prevent fetal death. Prognostic models have been developed to predict the risk of stillbirth, but none has yet been validated externally. In this study, we externally validated published prediction models for stillbirth using individual participant data (IPD) meta-analysis to assess their predictive performance., Methods: MEDLINE, EMBASE, DH-DATA and AMED databases were searched from inception to December 2020 to identify studies reporting stillbirth prediction models. Studies that developed or updated prediction models for stillbirth for use at any time during pregnancy were included. IPD from cohorts within the International Prediction of Pregnancy Complications (IPPIC) Network were used to validate externally the identified prediction models whose individual variables were available in the IPD. The risk of bias of the models and cohorts was assessed using the Prediction study Risk Of Bias ASsessment Tool (PROBAST). The discriminative performance of the models was evaluated using the C-statistic, and calibration was assessed using calibration plots, calibration slope and calibration-in-the-large. Performance measures were estimated separately in each cohort, as well as summarized across cohorts using random-effects meta-analysis. Clinical utility was assessed using net benefit., Results: Seventeen studies reporting the development of 40 prognostic models for stillbirth were identified. None of the models had been previously validated externally, and the full model equation was reported for only one-fifth (20%, 8/40) of the models. External validation was possible for three of these models, using IPD from 19 cohorts (491 201 pregnant women) within the IPPIC Network database. Based on evaluation of the model development studies, all three models had an overall high risk of bias, according to PROBAST. In the IPD meta-analysis, the models had summary C-statistics ranging from 0.53 to 0.65 and summary calibration slopes ranging from 0.40 to 0.88, with risk predictions that were generally too extreme compared with the observed risks. The models had little to no clinical utility, as assessed by net benefit. However, there remained uncertainty in the performance of some models due to small available sample sizes., Conclusions: The three validated stillbirth prediction models showed generally poor and uncertain predictive performance in new data, with limited evidence to support their clinical application. The findings suggest methodological shortcomings in their development, including overfitting. Further research is needed to further validate these and other models, identify stronger prognostic factors and develop more robust prediction models. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology., (© 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.)

Background: Perinatal deaths are a devastating experience for all families and healthcare professionals involved. Audit of perinatal mortality (PNM) is essential to better understand the factors associated with perinatal death, to identify key deficiencies in healthcare provision and should be utilised to improve the quality of perinatal care. However, barriers exist to successful audit implementation and few countries have implemented national perinatal audit programs., Content: We searched the PubMed, EMBASE and EBSCO host, including Medline, Academic Search Complete and CINAHL Plus databases for articles that were published from 1st January 2000. Articles evaluating perinatal mortality audits or audit implementation, identifying risk or care factors of perinatal mortality through audits, in middle and/or high-income countries were considered for inclusion in this review. Twenty articles met inclusion criteria. Incomplete datasets, nonstandard audit methods and classifications, and inadequate staff training were highlighted as barriers to PNM reporting and audit implementation. Failure in timely detection and management of antenatal maternal and fetal conditions and late presentation or failure to escalate care were the most common substandard care factors identified through audit. Overall, recommendations for perinatal audit focused on standardised audit tools and training of staff. Overall, the implementation of audit recommendations remains unclear., Summary: This review highlights barriers to audit practices and emphasises the need for adequately trained staff to participate in regular audit that is standardised and thorough. To achieve the goal of reducing PNM, it is crucial that the audit cycle is completed with continuous re-evaluation of recommended changes., (© 2022 Walter de Gruyter GmbH, Berlin/Boston.)

Background: It is important to examine perinatal deaths as part of a national mortality audit to identify risk factors. Implementing and re-evaluating recommendations from perinatal mortality audits completes the audit cycle, preventing similar deaths in the future. Lack of implementation results in recommendations recurring., Objectives: In this study we examine national perinatal mortality audits' methodology in four high-income countries (United Kingdom, New Zealand, Ireland, Netherlands) to highlight different approaches taken. We compare the recommendations made in these audits' reports over the last five years, as well as review national initiatives and programmes addressing them., Study Design: This study is an integrative review where two comprehensive literature searches were completed: on established national perinatal mortality audits in high-income countries; and on national initiatives addressing recommendations from these audits. Content analysis of the audits' recommendations was performed organising them into themes according to topics these focused on., Results: Though the methodology of the national perinatal mortality audits varied, all four were state-funded and had standardised online data collection forms to report deaths. The recommendations themes included: Raising public awareness of perinatal mortality risk factors, Detection of fetal growth restriction, Prevention of preterm birth, Resources for data collection and review. Only the UK had various initiatives addressing perinatal mortality risk factors directly. New Zealand included stakeholders in the audit recommendations' development and provided updates on their implementation. The Netherlands developed a programme for audit recommendation implementation. Ireland created a group which is progressing some recommendations from the audit., Conclusions: National perinatal mortality audits are important in identifying contributory factors and making recommendations to address these. Recurring recommendations suggest a failure to resolve the identified issues. This study shows how some challenges are common to high-income countries' audits, highlighting the need for shared learning of successful initiatives., 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 © 2021 Elsevier B.V. All rights reserved.)

Background: Perinatal mortality in foetuses/children with congenital anomalies remains high. Prenatal diagnosis, essential for risk assessment and organisation of perinatal/postnatal care, offers parents the opportunity to consider the termination of pregnancy. In times of quick changes in prenatal screening programmes, it is relevant to evaluate the effect of prenatal screening on perinatal mortality rates., Objectives: The objective of this study was to study trends in early foetal and perinatal mortality associated with congenital anomalies before/after the introduction of the Dutch prenatal screening programme., Methods: This population-based cohort study included 8535 foetuses/neonates with congenital anomalies born in the Northern Netherlands between 2001 and 2017. Total deaths were defined as sum of early foetal (before 24 weeks' gestation) and perinatal deaths (from 24 weeks' gestation till day 7 post-partum). Foetal deaths were categorised into spontaneous or elective termination of pregnancy for foetal anomalies (TOPFA). Trends in total mortality as well as early foetal and perinatal mortality were studied. Joinpoint regression was used to calculate the average annual percentage chance (AAPC) and identify linear trends in mortality within subperiods., Results: Total and perinatal mortality were 17% and 4%. Total mortality was higher in abnormal karyotype and central nervous system anomalies. We observed an increase in total mortality over time: 11.9% in 2001 versus 21.9% in 2017 (AAPC 2.6, 95% confidence interval [CI] 1.5, 3.7), caused by an increase in early foetal mortality from 5.5% to 19.2% (AAPC 8.7, 95% CI 4.7, 12.9) and a decrease in perinatal mortality from 6.4% to 2.7% (AAPC -5.6, 95% CI -10.0, -1.0). The increase in early foetal mortality reflects an increase in TOPFA from 3.6% to 16.9% (AAPC 8.3, 95% CI 4.2, 12.7), mostly occurring at 13-14 and 20-23 weeks' gestation., Conclusions: The introduction of the prenatal screening programme led to a decrease in perinatal mortality among foetuses and neonates with congenital anomalies and a marked increase in early foetal mortality before 24 weeks' gestation due to higher rates of TOPFA., (© 2021 The Authors. Paediatric and Perinatal Epidemiology published by John Wiley & Sons Ltd.)

Importance: Preeclampsia is a hypertensive disorder of pregnancy that poses serious maternal and infant health risks. Previous systematic reviews have established benefits of low-dose aspirin taken during pregnancy to prevent preeclampsia and its sequelae., Objective: To update evidence for the US Preventive Services Task Force (USPSTF) on effectiveness of aspirin use in preventing preeclampsia in individuals at increased risk based on clinical risk factors or measurements associated with higher disease incidence than in the general population., Data Sources: Studies from previous USPSTF review (2014), literature published January 2013 through May 15, 2020, in MEDLINE, PubMed (for publisher-supplied records only), EMBASE, and Cochrane Central Register of Controlled Trials. Ongoing surveillance through January 22, 2021., Study Selection: Good- and fair-quality randomized clinical trials (RCTs) of low-dose aspirin use during pregnancy to prevent preeclampsia among individuals at increased risk; studies conducted in general populations to evaluate potential harms., Data Extraction and Synthesis: Dual article screening and risk-of-bias assessment. Study data abstracted into prespecified forms, checked for accuracy. Random-effects meta-analysis., Main Outcomes and Measures: Diagnosis of preeclampsia; adverse pregnancy health outcomes and complications including eclampsia, perinatal mortality, preterm birth, small for gestational age, and potential bleeding harms or infant/child harms from aspirin exposure., Results: A total of 23 randomized clinical trials (RCTs) (N = 26 952) were included; 18 were conducted among participants at increased preeclampsia risk. Aspirin dosages ranged from 50 mg/d to 150 mg/d. Most trials enrolled majority White populations selected based on a range of risk factors. The incidence of preeclampsia among the trials of participants at increased risk ranged from 4% to 30%. Aspirin use was significantly associated with lower risk of preeclampsia (pooled relative risk [RR], 0.85 [95% CI, 0.75-0.95]; 16 RCTs [n = 14 093]; I2 = 0%), perinatal mortality (pooled RR, 0.79 [95% CI, 0.66-0.96]; 11 RCTs [n = 13 860]; I2 = 0%), preterm birth (pooled RR, 0.80 [95% CI, 0.67-0.95]; 13 RCTs [n = 13 619]; I2 = 49%), and intrauterine growth restriction (pooled RR, 0.82 [95% CI, 0.68-0.99]; 16 RCTs [n = 14 385]; I2 = 41%). There were no significant associations of aspirin use with risk of postpartum hemorrhage (pooled RR, 1.03 [95% CI, 0.94-1.12]; 9 RCTs [n = 23 133]; I2 = 0%) and other bleeding-related harms, or with rare perinatal or longer-term harms. Absolute risk reductions for preeclampsia associated with aspirin use ranged from -1% to -6% across larger trials (n >300) and were greater in smaller trials. For perinatal mortality, absolute risk reductions ranged from 0.5% to 1.1% in the 3 largest trials., Conclusions and Relevance: Daily low-dose aspirin during pregnancy was associated with lower risks of serious perinatal outcomes for individuals at increased risk for preeclampsia, without evident harms.

Importance: Preeclampsia is one of the most serious health problems that affect pregnant persons. It is a complication in approximately 4% of pregnancies in the US and contributes to both maternal and infant morbidity and mortality. Preeclampsia also accounts for 6% of preterm births and 19% of medically indicated preterm births in the US. There are racial and ethnic disparities in the prevalence of and mortality from preeclampsia. Non-Hispanic Black women are at greater risk for developing preeclampsia than other women and experience higher rates of maternal and infant morbidity and perinatal mortality., Objective: To update its 2014 recommendation, the USPSTF commissioned a systematic review to evaluate the effectiveness of low-dose aspirin use to prevent preeclampsia., Population: Pregnant persons at high risk for preeclampsia who have no prior adverse effects with or contraindications to low-dose aspirin., Evidence Assessment: The USPSTF concludes with moderate certainty that there is a substantial net benefit of daily low-dose aspirin use to reduce the risk for preeclampsia, preterm birth, small for gestational age/intrauterine growth restriction, and perinatal mortality in pregnant persons at high risk for preeclampsia., Recommendation: The USPSTF recommends the use of low-dose aspirin (81 mg/d) as preventive medication for preeclampsia after 12 weeks of gestation in persons who are at high risk for preeclampsia. (B recommendation).

Background: Stillbirth rates have shown little improvement for two decades in Australia. Perinatal mortality audit is key to prevention, but the literature suggests that implementation is suboptimal., Aim: To determine the proportion of perinatal deaths which are associated with contributing factors relating to care in Queensland, Australia., Materials and Methods: Retrospective audit of perinatal deaths ≥ 34 weeks gestation by the Health Department in Queensland was undertaken. Cases and demographic information were obtained from the Queensland Perinatal Data Collection. A multidisciplinary panel used the Perinatal Society of Australia and New Zealand (PSANZ) perinatal mortality audit guidelines to classify the cause of death and to identify contributing factors. Contributing factors were classified as 'insignificant', 'possible', or 'significant'., Results: From 1 January to 31 December 2018, 65 deaths (56 stillbirths and nine neonatal deaths) were eligible and audited. Most deaths were classified as unexplained (51.8% of stillbirths). Contributing factors were identified in 46 (71%) deaths: six insignificant (all stillbirths), 20 possibly related to outcome (17 stillbirths), and 20 significantly (16 stillbirths). Areas for practice improvements mainly related to the care for women with risk factors for stillbirth, especially antenatal care. The PSANZ guidelines were applied and enabled a systematic approach., Conclusions: A high proportion of late gestation perinatal deaths are associated with contributing factors relating to care. Improving antenatal care for women with risk factors for stillbirth is a priority. Perinatal mortality audit is a valuable step in stillbirth prevention and the PSANZ guidelines allow a systematic approach to aid implementation and reporting., (© 2021 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)