Mothers working to prevent early stillbirth study (MiNESS 20-28): a case-control study protocol.

INTRODUCTION: In the UK, 1600 babies die every year before, during or immediately after birth at 20-28 weeks' gestation. This bereavement has a similar impact on parental physical and psychological well-being to late stillbirth (>28 weeks' gestation). Improved understanding of potentially modifiable risk factors for late stillbirth (including supine going-to-sleep position) has influenced international clinical practice. Information is now urgently required to similarly inform clinical practice and aid decision-making by expectant mothers/parents, addressing inequalities in pregnancy loss between 20 and 28 weeks. METHODS AND ANALYSIS: This study focuses on what portion of risk of pregnancy loss 20-28 weeks' gestation is associated with exposures amenable to public health campaigns/antenatal care adaptation. A case-control study of non-anomalous singleton baby loss (via miscarriage, stillbirth or early neonatal death) 20+0 to 27+6 (n=316) and randomly selected control pregnancies (2:1 ratio; n=632) at group-matched gestations will be conducted. Data is collected via participant recall (researcher-administered questionnaire) and extraction from contemporaneous medical records. Unadjusted/confounder-adjusted ORs will be calculated. Exposures associated with early stillbirth at OR≥1.5 will be detectable (p<0.05, ß>0.80) assuming exposure prevalence of 30%-60%. ETHICS AND DISSEMINATION: NHS research ethical approval has been obtained from the London-Seasonal research ethics committee (23/LO/0622). The results will be presented at international conferences and published in peer-reviewed open-access journals. Information from this study will enable development of antenatal care and education for healthcare professionals and pregnant people to reduce risk of early stillbirth. TRIAL REGISTRATION NUMBER: NCT06005272.

Midwives' and obstetricians' practice, perspectives and experiences in relation to altered fetal movement: A focused ethnographic study.

BACKGROUND: Reducing avoidable stillbirth is a global priority. The stillbirth rate in England compares unfavourably to that of some other high-income countries. Poorly-managed episodes of altered fetal movement have been highlighted as a key contributor to avoidable stillbirth, and strategies introduced in England in 2016 to reduce perinatal mortality included recommendations for the management of reduced fetal movement. Despite a downward trend in stillbirth rates across the UK, the effects of policies promoting awareness of fetal movement remain uncertain. OBJECTIVE: To provide in-depth knowledge of how practice and clinical guidance relating to altered fetal movement are perceived, enacted and experienced by midwives and obstetricians, and explore the relationship between recommended fetal movement care and actual fetal movement care. DESIGN: A focused ethnographic approach comprising over 180 h of observation, 15 interviews, and document analysis was used to explore practice at two contrasting UK maternity units. SETTINGS: Antenatal services at two UK maternity units, one in the Midlands and one in the North of England. PARTICIPANTS: Thirty-six midwives, obstetricians and sonographers and 40 pregnant women participated in the study across 52 observed care episodes and relevant unit activity. Twelve midwives and three obstetricians additionally participated in formal semi-structured interviews. METHODS: Fieldnotes, interview transcripts, policy documents, maternity notes and clinical guidelines were analysed using a modified constant comparison method to identify important themes. RESULTS: fetal movement practice was mostly consistent and in line with guideline recommendations. Notwithstanding, most midwives and obstetricians had concerns about this area of care, including challenges in diagnosis, conflicting evidence about activity, heightened maternal anxiety, and high rates of monitoring and intervention in otherwise low-risk pregnancies. To address these issues, midwives spent considerable time reassuring women through information and regular monitoring, and coaching them to perceive fetal movement more accurately. CONCLUSIONS: Practice relating to altered fetal movement might be more uniform than in the past. However, a heightened focus on fetal movement is associated by some midwives and obstetricians with potential harms, including increased anxiety in pregnancy, and high rates of monitoring and intervention in pregnancies where there are no 'objective concerns'. Challenges in diagnosing a significant change in fetal movement with accuracy might mean that interventions and resources are not being directed towards those pregnancies most at risk. More research is needed to determine how healthcare professionals can engage in conversations about fetal movement and stillbirth to support safe outcomes and positive experiences in pregnancy and birth. REGISTRATION: Not registered. TWEETABLE ABSTRACT: Midwives and obstetricians take #reducedfetalmovement seriously but worry this 'unreliable' symptom increases anxiety, monitoring and intervention in many 'low risk' pregnancies.

Effect of national guidance on survival for babies born at 22 weeks' gestation in England and Wales: population based cohort study.

Objectives: To explore the effect of changes in national clinical recommendations in 2019 that extended provision of survival focused care to babies born at 22 weeks' gestation in England and Wales. Design: Population based cohort study. Setting: England and Wales, comprising routine data for births and hospital records. Participants: Babies alive at the onset of care in labour at 22 weeks+0 days to 22 weeks+6 days and at 23 weeks+0 days to 24 weeks+6 days for comparison purposes between 1 January 2018 and 31 December 2021. Main outcome measures: Percentage of babies given survival focused care (active respiratory support after birth), admitted to neonatal care, and surviving to discharge in 2018-19 and 2020-21. Results: For the 1001 babies alive at the onset of labour at 22 weeks' gestation, a threefold increase was noted in: survival focused care provision from 11.3% to 38.4% (risk ratio 3.41 (95% confidence interval 2.61 to 4.45)); admissions to neonatal units from 7.4% to 28.1% (3.77 (2.70 to 5.27)), and survival to discharge from neonatal care from 2.5% to 8.2% (3.29 (1.78 to 6.09)). More babies of lower birth weight and early gestational age received survival focused care in 2020-21 than 2018-19 (46% to 64% at <500g weight; 19% to 31% at 22 weeks+0 days to 22 weeks+3 days). Conclusions: A change in national guidance to recommend a risk based approach was associated with a threefold increase in 22 weeks' gestation babies receiving survival focused care. The number of babies being admitted to neonatal units and those surviving to discharge increased.

Stillbirths: Contribution of preterm birth and size-for-gestational age for 125.4 million total births from nationwide records in 13 countries, 2000-2020.

OBJECTIVE: To examine the contribution of preterm birth and size-for-gestational age in stillbirths using six 'newborn types'. DESIGN: Population-based multi-country analyses. SETTING: Births collected through routine data systems in 13 countries. SAMPLE: 125 419 255 total births from 22+0 to 44+6 weeks' gestation identified from 2000 to 2020. METHODS: We included 635 107 stillbirths from 22+0 weeks' gestation from 13 countries. We classified all births, including stillbirths, into six 'newborn types' based on gestational age information (preterm, PT, <37+0 weeks versus term, T, ≥37+0 weeks) and size-for-gestational age defined as small (SGA, <10th centile), appropriate (AGA, 10th-90th centiles) or large (LGA, >90th centile) for gestational age, according to the international newborn size for gestational age and sex INTERGROWTH-21st standards. MAIN OUTCOME MEASURES: Distribution of stillbirths, stillbirth rates and rate ratios according to six newborn types. RESULTS: 635 107 (0.5%) of the 125 419 255 total births resulted in stillbirth after 22+0 weeks. Most stillbirths (74.3%) were preterm. Around 21.2% were SGA types (PT + SGA [16.2%], PT + AGA [48.3%], T + SGA [5.0%]) and 14.1% were LGA types (PT + LGA [9.9%], T + LGA [4.2%]). The median rate ratio (RR) for stillbirth was highest in PT + SGA babies (RR 81.1, interquartile range [IQR], 68.8-118.8) followed by PT + AGA (RR 25.0, IQR, 20.0-34.3), PT + LGA (RR 25.9, IQR, 13.8-28.7) and T + SGA (RR 5.6, IQR, 5.1-6.0) compared with T + AGA. Stillbirth rate ratios were similar for T + LGA versus T + AGA (RR 0.7, IQR, 0.7-1.1). At the population level, 25% of stillbirths were attributable to small-for-gestational-age. CONCLUSIONS: In these high-quality data from high/middle income countries, almost three-quarters of stillbirths were born preterm and a fifth small-for-gestational age, with the highest stillbirth rates associated with the coexistence of preterm and SGA. Further analyses are needed to better understand patterns of gestation-specific risk in these populations, as well as patterns in lower-income contexts, especially those with higher rates of intrapartum stillbirth and SGA.

Neonatal mortality risk of large-for-gestational-age and macrosomic live births in 15 countries, including 115.6 million nationwide linked records, 2000-2020.

OBJECTIVE: We aimed to compare the prevalence and neonatal mortality associated with large for gestational age (LGA) and macrosomia among 115.6 million live births in 15 countries, between 2000 and 2020. DESIGN: Population-based, multi-country study. SETTING: National healthcare systems. POPULATION: Liveborn infants. METHODS: We used individual-level data identified for the Vulnerable Newborn Measurement Collaboration. We calculated the prevalence and relative risk (RR) of neonatal mortality among live births born at term + LGA (>90th centile, and also >95th and >97th centiles when the data were available) versus term + appropriate for gestational age (AGA, 10th-90th centiles) and macrosomic (≥4000, ≥4500 and ≥5000 g, regardless of gestational age) versus 2500-3999 g. INTERGROWTH 21st served as the reference population. MAIN OUTCOME MEASURES: Prevalence and neonatal mortality risks. RESULTS: Large for gestational age was common (median prevalence 18.2%; interquartile range, IQR, 13.5%-22.0%), and overall was associated with a lower neonatal mortality risk compared with AGA (RR 0.83, 95% CI 0.77-0.89). Around one in ten babies were ≥4000 g (median prevalence 9.6% (IQR 6.4%-13.3%), with 1.2% (IQR 0.7%-2.0%) ≥4500 g and with 0.2% (IQR 0.1%-0.2%) ≥5000 g). Overall, macrosomia of ≥4000 g was not associated with increased neonatal mortality risk (RR 0.80, 95% CI 0.69-0.94); however, a higher risk was observed for birthweights of ≥4500 g (RR 1.52, 95% CI 1.10-2.11) and ≥5000 g (RR 4.54, 95% CI 2.58-7.99), compared with birthweights of 2500-3999 g, with the highest risk observed in the first 7 days of life. CONCLUSIONS: In this population, birthweight of ≥4500 g was the most useful marker for early mortality risk in big babies and could be used to guide clinical management decisions.

Neonatal mortality risk for vulnerable newborn types in 15 countries using 125.5 million nationwide birth outcome records, 2000-2020.

OBJECTIVE: To compare neonatal mortality associated with six novel vulnerable newborn types in 125.5 million live births across 15 countries, 2000-2020. DESIGN: Population-based, multi-country study. SETTING: National data systems in 15 middle- and high-income countries. METHODS: We used individual-level data sets identified for the Vulnerable Newborn Measurement Collaboration. We examined the contribution to neonatal mortality of six newborn types combining gestational age (preterm [PT] versus term [T]) and size-for-gestational age (small [SGA], <10th centile, appropriate [AGA], 10th-90th centile or large [LGA], >90th centile) according to INTERGROWTH-21st newborn standards. Newborn babies with PT or SGA were defined as small and T + LGA was considered as large. We calculated risk ratios (RRs) and population attributable risks (PAR%) for the six newborn types. MAIN OUTCOME MEASURES: Mortality of six newborn types. RESULTS: Of 125.5 million live births analysed, risk ratios were highest among PT + SGA (median 67.2, interquartile range [IQR] 45.6-73.9), PT + AGA (median 34.3, IQR 23.9-37.5) and PT + LGA (median 28.3, IQR 18.4-32.3). At the population level, PT + AGA was the greatest contributor to newborn mortality (median PAR% 53.7, IQR 44.5-54.9). Mortality risk was highest among newborns born before 28 weeks (median RR 279.5, IQR 234.2-388.5) compared with babies born between 37 and 42 completed weeks or with a birthweight less than 1000 g (median RR 282.8, IQR 194.7-342.8) compared with those between 2500 g and 4000 g as a reference group. CONCLUSION: Preterm newborn types were the most vulnerable, and associated with the highest mortality, particularly with co-existence of preterm and SGA. As PT + AGA is more prevalent, it is responsible for the greatest burden of neonatal deaths at population level.

Vulnerable newborn types: Analysis of population-based registries for 165 million births in 23 countries, 2000-2021.

OBJECTIVE: To examine the prevalence of novel newborn types among 165 million live births in 23 countries from 2000 to 2021. DESIGN: Population-based, multi-country analysis. SETTING: National data systems in 23 middle- and high-income countries. POPULATION: Liveborn infants. METHODS: Country teams with high-quality data were invited to be part of the Vulnerable Newborn Measurement Collaboration. We classified live births by six newborn types based on gestational age information (preterm <37 weeks versus term ≥37 weeks) and size for gestational age defined as small (SGA, <10th centile), appropriate (10th-90th centiles), or large (LGA, >90th centile) for gestational age, according to INTERGROWTH-21st standards. We considered small newborn types of any combination of preterm or SGA, and term + LGA was considered large. Time trends were analysed using 3-year moving averages for small and large types. MAIN OUTCOME MEASURES: Prevalence of six newborn types. RESULTS: We analysed 165 017 419 live births and the median prevalence of small types was 11.7% - highest in Malaysia (26%) and Qatar (15.7%). Overall, 18.1% of newborns were large (term + LGA) and was highest in Estonia 28.8% and Denmark 25.9%. Time trends of small and large infants were relatively stable in most countries. CONCLUSIONS: The distribution of newborn types varies across the 23 middle- and high-income countries. Small newborn types were highest in west Asian countries and large types were highest in Europe. To better understand the global patterns of these novel newborn types, more information is needed, especially from low- and middle-income countries.

Estimated neonatal survival of very preterm births across the care pathway: a UK cohort 2016-2020.

OBJECTIVE: Currently used estimates of survival are nearly 10 years old and relate to only those babies admitted for neonatal care. Due to ongoing improvements in neonatal care, here we update estimates of survival for singleton and multiple births at 22+0 to 31+6 weeks gestational age across the perinatal care pathway by gestational age and birth weight. DESIGN: Retrospective analysis of routinely collected data. SETTING: A national cohort from the UK and British Crown Dependencies. PATIENTS: Babies born at 22+0 to 31+6 weeks gestational age from 1 January 2016 to 31 December 2020. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Survival to 28 days. RESULTS: Estimates of neonatal survival are provided for babies: (1) alive at the onset of care during the birthing process (n=43 763); (2) babies where survival-focused care was initiated (n=42 004); and (3) babies admitted for neonatal care (n=41 158). We have produced easy-to-use survival charts for singleton and multiple births. Generally, survival increased with increasing gestational age at birth and with increasing birth weight. For all births with a birthweight over 1000 g, survival was 90% or higher at all three stages of care. CONCLUSIONS: Survival estimates are a vital tool to support and supplement clinical judgement within perinatal care. These up-to-date, national estimates of survival to 28 days are provided based on three stages of the perinatal care pathway to support ongoing clinical care. These novel results are a key resource for policy and practice including counselling parents and informing care provision.

Understanding ethnic inequalities in stillbirth rates: a UK population-based cohort study.

OBJECTIVES: To investigate inequalities in stillbirth rates by ethnicity to facilitate development of initiatives to target those at highest risk. DESIGN: Population-based perinatal mortality surveillance linked to national birth and death registration (Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries across the UK). SETTING: UK. PARTICIPANTS: 4 391 569 singleton births at ≥24+0 weeks gestation between 2014 and 2019. MAIN OUTCOME MEASURES: Stillbirth rate difference per 1000 total births by ethnicity. RESULTS: Adjusted absolute differences in stillbirth rates were higher for babies of black African (3.83, 95% CI 3.35 to 4.32), black Caribbean (3.60, 95% CI 2.65 to 4.55) and Pakistani (2.99, 95% CI 2.58 to 3.40) ethnicities compared with white ethnicities. Higher proportions of babies of Bangladeshi (42%), black African (39%), other black (39%) and black Caribbean (37%) ethnicities were from most deprived areas, which were associated with an additional risk of 1.50 stillbirths per 1000 births (95% CI 1.32 to 1.67). Exploring primary cause of death, higher stillbirth rates due to congenital anomalies were observed in babies of Pakistani, Bangladeshi and black African ethnicities (range 0.63-1.05 per 1000 births) and more placental causes in black ethnicities (range 1.97 to 2.24 per 1000 births). For the whole population, over 40% of stillbirths were of unknown cause; however, this was particularly high for babies of other Asian (60%), Bangladeshi (58%) and Indian (52%) ethnicities. CONCLUSIONS: Stillbirth rates declined in the UK, but substantial excess risk of stillbirth persists among babies of black and Asian ethnicities. The combined disadvantage for black, Pakistani and Bangladeshi ethnicities who are more likely to live in most deprived areas is associated with considerably higher rates. Key causes of death were congenital anomalies and placental causes. Improved strategies for investigation of stillbirth causes are needed to reduce unexplained deaths so that interventions can be targeted to reduce stillbirths.

Global, regional, and national estimates and trends in stillbirths from 2000 to 2019: a systematic assessment.

BACKGROUND: Stillbirths are a major public health issue and a sensitive marker of the quality of care around pregnancy and birth. The UN Global Strategy for Women's, Children's and Adolescents' Health (2016-30) and the Every Newborn Action Plan (led by UNICEF and WHO) call for an end to preventable stillbirths. A first step to prevent stillbirths is obtaining standardised measurement of stillbirth rates across countries. We estimated stillbirth rates and their trends for 195 countries from 2000 to 2019 and assessed progress over time. METHODS: For a systematic assessment, we created a dataset of 2833 country-year datapoints from 171 countries relevant to stillbirth rates, including data from registration and health information systems, household-based surveys, and population-based studies. After data quality assessment and exclusions, we used 1531 datapoints to estimate country-specific stillbirth rates for 195 countries from 2000 to 2019 using a Bayesian hierarchical temporal sparse regression model, according to a definition of stillbirth of at least 28 weeks' gestational age. Our model combined covariates with a temporal smoothing process such that estimates were informed by data for country-periods with high quality data, while being based on covariates for country-periods with little or no data on stillbirth rates. Bias and additional uncertainty associated with observations based on alternative stillbirth definitions and source types, and observations that were subject to non-sampling errors, were included in the model. We compared the estimated stillbirth rates and trends to previously reported mortality estimates in children younger than 5 years. FINDINGS: Globally in 2019, an estimated 2·0 million babies (90% uncertainty interval [UI] 1·9-2·2) were stillborn at 28 weeks or more of gestation, with a global stillbirth rate of 13·9 stillbirths (90% UI 13·5-15·4) per 1000 total births. Stillbirth rates in 2019 varied widely across regions, from 22·8 stillbirths (19·8-27·7) per 1000 total births in west and central Africa to 2·9 (2·7-3·0) in western Europe. After west and central Africa, eastern and southern Africa and south Asia had the second and third highest stillbirth rates in 2019. The global annual rate of reduction in stillbirth rate was estimated at 2·3% (90% UI 1·7-2·7) from 2000 to 2019, which was lower than the 2·9% (2·5-3·2) annual rate of reduction in neonatal mortality rate (for neonates aged <28 days) and the 4·3% (3·8-4·7) annual rate of reduction in mortality rate among children aged 1-59 months during the same period. Based on the lower bound of the 90% UIs, 114 countries had an estimated decrease in stillbirth rate since 2000, with four countries having a decrease of at least 50·0%, 28 having a decrease of 25·0-49·9%, 50 having a decrease of 10·0-24·9%, and 32 having a decrease of less than 10·0%. For the remaining 81 countries, we found no decrease in stillbirth rate since 2000. Of these countries, 34 were in sub-Saharan Africa, 16 were in east Asia and the Pacific, and 15 were in Latin America and the Caribbean. INTERPRETATION: Progress in reducing the rate of stillbirths has been slow compared with decreases in the mortality rate of children younger than 5 years. Accelerated improvements are most needed in the regions and countries with high stillbirth rates, particularly in sub-Saharan Africa. Future prevention of stillbirths needs increased efforts to raise public awareness, improve data collection, assess progress, and understand public health priorities locally, all of which require investment. FUNDING: Bill & Melinda Gates Foundation and the UK Foreign, Commonwealth and Development Office.

Impact of sociodemographic and clinical factors on offer and parental consent to postmortem following stillbirth or neonatal death: a UK population-based cohort study.

OBJECTIVE: To identify factors associated with the offer of and consent to perinatal post-mortem. DESIGN: National population-based cohort study SETTING: The UK. POPULATION: 26 578 perinatal deaths born between 1 January 2013 and 31 December 2017. MAIN OUTCOME MEASURES: Postmortem offer by clinical staff; parental consent to post-mortem. RESULTS: Postmortem offer rates were high but varied significantly with time of death from 97.8% for antepartum deaths to 88.4% for neonatal deaths following neonatal admission. Offer rates did not significantly vary by gestation, year of birth, mother's socioeconomic deprivation, ethnicity or age. Only 44.5% of parents consented to a postmortem. Mothers from the most deprived areas were less likely to consent than those from the least deprived areas (relative risk (RR)=0.76, 95% CI 0.71 to 0.80). Consent rates were similar for mothers of white, mixed, Asian Indian, black Caribbean and black African ethnicity (43%-47%), but significantly lower for mothers of Asian Pakistani (20%) and Asian Bangladeshi (18%) ethnicity. Consent increased with increasing gestation (p<0.001) and was lower for deaths following neonatal unit admission than for antepartum death (RR 0.71, 95% CI 0.67 to 0.75). CONCLUSIONS: The current profile of cause of perinatal deaths in the UK is likely to be biased with less postmortem information available for babies dying in the neonatal period and those born to mothers from deprived areas and of Asian Pakistani or Asian Bangladeshi ethnicity. Such bias severely limits the design of effective strategies for reducing mortality in these high-risk groups. These findings have implications for high-income countries seeking to explore and improve the understanding of perinatal deaths.

Assessing the deprivation gap in stillbirths and neonatal deaths by cause of death: a national population-based study.

OBJECTIVE: To investigate socioeconomic inequalities in cause-specific stillbirth and neonatal mortality to identify key areas of focus for future intervention strategies to achieve government ambitions to reduce mortality rates. DESIGN: Retrospective cohort study. SETTING: England, Wales, Scotland and the UK Crown Dependencies. PARTICIPANTS: All singleton births between 1 January 2014 and 31 December 2015 at ≥24 weeks' gestation. MAIN OUTCOME MEASURE: Cause-specific stillbirth or neonatal death (0-27 days after birth) per 10 000 births by deprivation quintile. RESULTS: Data on 5694 stillbirths (38.1 per 10 000 total births) and 2368 neonatal deaths (15.9 per 10 000 live births) were obtained from Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries across the UK (MBRRACE-UK). Women from the most deprived areas were 1.68 (95% CI 1.56 to 1.81) times more likely to experience a stillbirth and 1.67 (95% CI 1.48 to 1.87) times more likely to experience a neonatal death than those from the least deprived areas, equating to an excess of 690 stillbirths and 231 neonatal deaths per year associated with deprivation. Small for gestational age (SGA) unexplained antepartum stillbirth was the greatest contributor to excess stillbirths accounting for 33% of the deprivation gap in stillbirths. Congenital anomalies accounted for the majority (59%) of the deprivation gap in neonatal deaths, followed by preterm birth not SGA (24-27 weeks, 27%). CONCLUSIONS: Cause-specific mortality rates at a national level allow identification of key areas of focus for future intervention strategies to reduce mortality. Despite a reduction in the deprivation gap for stillbirths and neonatal deaths, public health interventions should primarily focus on socioeconomic determinants of SGA stillbirth and congenital anomalies.

Quantifying the burden of stillbirths before 28 weeks of completed gestational age in high-income countries: a population-based study of 19 European countries.

BACKGROUND: International comparisons of stillbirth allow assessment of variations in clinical practice to reduce mortality. Currently, such comparisons include only stillbirths from 28 or more completed weeks of gestational age, which underestimates the true burden of stillbirth. With increased registration of early stillbirths in high-income countries, we assessed the reliability of including stillbirths before 28 completed weeks in such comparisons. METHODS: In this population-based study, we used national cohort data from 19 European countries participating in the Euro-Peristat project on livebirths and stillbirths from 22 completed weeks of gestation in 2004, 2010, and 2015. We excluded countries without national data for stillbirths by gestational age in these periods, or where data available were not comparable between 2004 and 2015. We also excluded those countries with fewer than 10 000 births per year because the proportion of stillbirths at 22 weeks to less than 28 weeks of gestation is small. We calculated pooled stillbirth rates using a random-effects model and changes in rates between 2004 and 2015 using risk ratios (RR) by gestational age and country. FINDINGS: Stillbirths at 22 weeks to less than 28 weeks of gestation accounted for 32% of all stillbirths in 2015. The pooled stillbirth rate at 24 weeks to less than 28 weeks declined from 0·97 to 0·70 per 1000 births from 2004 to 2015, a reduction of 25% (RR 0·75, 95% CI 0·65-0·85). The pooled stillbirth rate at 22 weeks to less than 24 weeks of gestation in 2015 was 0·53 per 1000 births and did not significantly changed over time (RR 0·97, 95% CI 0·80-1·16) although changes varied widely between countries (RRs 0·62-2·09). Wide variation in the percentage of all births occurring at 22 weeks to less than 24 weeks of gestation suggest international differences in ascertainment. INTERPRETATION: Present definitions used for international comparisons exclude a third of stillbirths. International consistency of reporting stillbirths at 24 weeks to less than 28 weeks suggests these deaths should be included in routinely reported comparisons. This addition would have a major impact, acknowledging the burden of perinatal death to families, and making international assessments more informative for clinical practice and policy. Ascertainment of fetal deaths at 22 weeks to less than 24 weeks should be stabilised so that all stillbirths from 22 completed weeks of gestation onwards can be reliably compared. FUNDING: EU Union under the framework of the Health Programme and the Bridge Health Project.

An International Comparison of Death Classification at 22 to 25 Weeks' Gestational Age.

OBJECTIVES: To explore international differences in the classification of births at extremely low gestation and the subsequent impact on the calculation of survival rates. METHODS: We used national data on births at 22 to 25 weeks' gestation from the United States (2014; n = 11 144), Canada (2009-2014; n = 5668), the United Kingdom (2014-2015; n = 2992), Norway (2010-2014; n = 409), Finland (2010-2015; n = 348), Sweden (2011-2014; n = 489), and Japan (2014-2015; n = 2288) to compare neonatal survival rates using different denominators: all births, births alive at the onset of labor, live births, live births surviving to 1 hour, and live births surviving to 24 hours. RESULTS: For births at 22 weeks' gestation, neonatal survival rates for which we used live births as the denominator varied from 3.7% to 56.7% among the 7 countries. This variation decreased when the denominator was changed to include stillbirths (ie, all births [1.8%-22.3%] and fetuses alive at the onset of labor [3.7%-38.2%]) or exclude early deaths and limited to births surviving at least 12 hours (50.0%-77.8%). Similar trends were seen for infants born at 23 weeks' gestation. Variation diminished considerably at 24 and 25 weeks' gestation. CONCLUSIONS: International variation in neonatal survival rates at 22 to 23 weeks' gestation diminished considerably when including stillbirths in the denominator, revealing the variation arises in part from differences in the proportion of births reported as live births, which itself is closely connected to the provision of active care.

Diagnosis of a severe congenital anomaly: A qualitative analysis of parental decision making and the implications for healthcare encounters.

OBJECTIVE: To explore parental decision making following diagnosis of a severe congenital anomaly, and implications for healthcare encounters. DESIGN: Qualitative semi-structured interviews with 38 parents-to-be were collated and triangulated with data generated from consultation recordings. ANALYSIS: Data were analysed using a constant comparative-based approach. SETTING: Recruitment was undertaken across four fetal medicine sites in two tertiary referral trusts. PARTICIPANTS: Parents-to-be whose pregnancy was suspected or diagnosed as being affected by a severe congenital anomaly. This sample was purposive to include known factors affecting the decision to terminate or continue the affected pregnancy. FINDINGS: In trying to make a decision about how to proceed with their pregnancy, parents-to-be typically had to work hard to negotiate multiple uncertainties around the diagnosis and prognosis of the suspected anomaly. This was influenced by parents' capacity to cope with uncertainty and the way in which uncertainty was managed by the clinical team. This negotiation of uncertainty was enacted within a fluid, nonlinear three-phase process: "information seeking," reflecting the way parents-to-be face the uncertainty associated with a fetal diagnosis and associated prognosis; "implications," where consideration is given to future consequences of the decision; and "decision making," which reflects the way in which the decision is made (head- or heart-led). Spectrums of responses were apparent within each phase. CONCLUSIONS: This study provides important insights into how parents-to-be make decisions following diagnosis or suspicion of a severe congenital anomaly. The impact of these on healthcare encounters is discussed, alongside recommendations for clinical practice.

Updated birth weight centiles for England and Wales.

OBJECTIVES: Construct updated birth weight-for-gestational age centile charts for use in the UK and compare these to the currently used UK-WHO charts. DESIGN: Secondary analysis of national birth data. PARTICIPANTS: Centiles were constructed using 1 269 403 singleton births occurring in England and Wales in 2013-2014 as part of the MBRRACE-UK national perinatal surveillance programme. These were then validated using 642 737 singleton births occurring in England and Wales in 2015. MAIN OUTCOME MEASURES: Sex-specific birth weight-for-gestational age centiles. Centiles were created using the lambda-mu-sigma method via the GAMLSS package in R. This method transforms the skewed birth weight distribution to approximate a normal distribution, allowing any birth weight centile to be produced. RESULTS: The new centiles performed well in the validation sample, with the observed and expected proportion of births below a given centile in agreement. Overall, driven by the predominance of term births, the UK-WHO charts classify a smaller proportion of infants as below a given centile. For example, the UK-WHO estimates classified only 1.32% (8035/606 430) of term infants born in 2015 as below the second centile, compared with 1.97% (11 975/606 430) using the new MBRRACE-UK centiles. At the earliest gestational ages, however, the opposite is observed, with the UK-WHO classifying a larger proportion of infants as below a given centile, particularly at the lower end of the birthweight distribution. CONCLUSIONS: We have constructed and validated updated birth weight-for-gestational age centiles using a contemporary sample of births occurring in England and Wales. The benefits of these updated centiles will be first to assist the national surveillance of perinatal mortality programme by improving the identification of the proportion of stillbirths and neonatal deaths affected by intrauterine growth restriction and, second, to aid clinicians by more accurately identifying babies who require increased monitoring in the period immediately following birth.

Clinicians' perspectives of parental decision-making following diagnosis of a severe congenital anomaly: a qualitative study.

OBJECTIVE: To explore clinicians' perspectives on supporting parents' decision-making following diagnosis of a severe congenital anomaly, and how this is shaped by current policy. METHODS: This paper reports data collated as part of a larger project examining parents' decision-making following antenatal diagnosis. The focus of this paper is the data arising from semistructured interviews conducted with 18 clinicians, with findings further supported by data generated from consultations between clinicians and parents. All interviews and consultations were audio-recorded and transcribed verbatim, with analysis based on the constant comparative approach. RESULTS: Three key themes emerged which together shape the practice of clinicians working in this area: first, the law governing termination of pregnancy (TOP) and how clinicians believe this influences the context in which decisions about whether to terminate or continue an affected pregnancy are made; second, approaches to the management of cases seen as particularly challenging; and third, how clinicians understand their role when working with parents. These themes combine to create a strong desire on the part of clinicians for parents to engage in a particular 'rational' form of decision-making and to be able to demonstrate the enactment of this. This is seen as important in order to ensure the 'right' decision has been reached and, particularly when the decision is to terminate, will withstand possible scrutiny. CONCLUSIONS: The policy context in which these decisions are made strongly shapes how clinicians practise and what they want to see from the parents with whom they work. The ways in which they seek to overcome the difficulties in interpreting the law may result in variations in the offer of late TOP, both between and within units. This may inadvertently affect the options available to women least able to engage in this idealised form of decision-making.