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.

Does fetal size affect maternal perception of fetal movements? Evidence from an individual participant data meta-analysis.

INTRODUCTION: Maternal perception of fetal movements during pregnancy are reassuring; however, the perception of a reduction in movements are concerning to women and known to be associated with increased odds of late stillbirth. Prior to full term, little evidence exists to provide guidelines on how to proceed unless there is an immediate risk to the fetus. Increased strength of movement is the most commonly reported perception of women through to full term, but perception of movement is also hypothesized to be influenced by fetal size. The study aimed to assess the pattern of maternal perception of strength and frequency of fetal movement by gestation and customized birthweight quartile in ongoing pregnancies. A further aim was to assess the association of stillbirth to perception of fetal movements stratified by customized birthweight quartile. MATERIAL AND METHODS: This analysis was an individual participant data meta-analyses of five case-control studies investigating factors associated with stillbirth. The dataset included 851 cases of women with late stillbirth (>28 weeks' gestation) and 2257 women with ongoing pregnancies who then had a liveborn infant. RESULTS: The frequency of prioritized fetal movement from 28 weeks' gestation showed a similar pattern for each quartile of birthweight with increased strength being the predominant perception of fetal movement through to full term. The odds of stillbirth associated with reduced fetal movements was increased in all quartiles of customized birthweight centiles but was notably greater in babies in the lowest two quartiles (Q1: adjusted OR: 9.34, 95% CI: 5.43, 16.06 and Q2: adjusted OR: 6.11, 95% CI: 3.11, 11.99). The decreased odds associated with increased strength of movement was present for all customized birthweight quartiles (adjusted OR range: 0.25-0.56). CONCLUSIONS: Increased strength of fetal movements in late pregnancy is a positive finding irrespective of fetal size. However, reduced fetal movements are associated with stillbirth, and more so when the fetus is small.

Risk factors for late preterm and term stillbirth: A secondary analysis of an individual participant data meta-analysis.

OBJECTIVE: Identify independent and novel risk factors for late-preterm (28-36 weeks) and term (≥37 weeks) stillbirth and explore development of a risk-prediction model. DESIGN: Secondary analysis of an Individual Participant Data (IPD) meta-analysis investigating modifiable stillbirth risk factors. SETTING: An IPD database from five case-control studies in New Zealand, Australia, the UK and an international online study. POPULATION: Women with late-stillbirth (cases, n = 851), and ongoing singleton pregnancies from 28 weeks' gestation (controls, n = 2257). METHODS: Established and novel risk factors for late-preterm and term stillbirth underwent univariable and multivariable logistic regression modelling with multiple sensitivity analyses. Variables included maternal age, body mass index (BMI), parity, mental health, cigarette smoking, second-hand smoking, antenatal-care utilisation, and detailed fetal movement and sleep variables. MAIN OUTCOME MEASURES: Independent risk factors with adjusted odds ratios (aOR) for late-preterm and term stillbirth. RESULTS: After model building, 575 late-stillbirth cases and 1541 controls from three contributing case-control studies were included. Risk factor estimates from separate multivariable models of late-preterm and term stillbirth were compared. As these were similar, the final model combined all late-stillbirths. The single multivariable model confirmed established demographic risk factors, but additionally showed that fetal movement changes had both increased (decreased frequency) and reduced (hiccoughs, increasing strength, frequency or vigorous fetal movements) aOR of stillbirth. Poor antenatal-care utilisation increased risk while more-than-adequate care was protective. The area-under-the-curve was 0.84 (95% CI 0.82-0.86). CONCLUSIONS: Similarities in risk factors for late-preterm and term stillbirth suggest the same approach for risk-assessment can be applied. Detailed fetal movement assessment and inclusion of antenatal-care utilisation could be valuable in late-stillbirth risk assessment.

Fetal movements: A framework for antenatal conversations.

BACKGROUND: Presentations for decreased fetal movements comprise a significant proportion of acute antenatal assessments. Decreased fetal movements are associated with increased likelihood of adverse pregnancy outcomes including stillbirth. Consensus-based guidelines recommend pregnant women routinely receive information about fetal movements, but practice is inconsistent, and the information shared is frequently not evidence-based. There are also knowledge gaps about the assessment and management of fetal movement concerns. Women have indicated that they would like more accurate information about what to expect regarding fetal movements. DISCUSSION: Historically, fetal movement information has focussed on movement counts. This is problematic, as the number of fetal movements perceived varies widely between pregnant women, and no set number of movements has been established as a reliable indicator of fetal wellbeing. Of late, maternity care providers have also advised women to observe their baby's movement pattern, and promptly present if they notice a change. However, normal fetal movement patterns are rarely defined. Recently, a body of research has emerged relating to maternal perception of fetal movement features such as strength, presence of hiccups, and diurnal pattern as indicators of fetal wellbeing in addition to frequency. CONCLUSION: Sharing comprehensive and gestation-appropriate information about fetal movements may be more satisfying for women, empowering women to identify for themselves when their baby is doing well, and importantly when additional assessment is needed. We propose a conversational approach to fetal movement information sharing, focusing on fetal movement strength, frequency, circadian pattern, and changes with normal fetal development, tailored to the individual.

'I don't need you to criticise me, I need you to support me'. A qualitative study of women's experiences of and attitudes to smoking cessation during pregnancy.

BACKGROUND: Smoking is associated with health inequalities and is the most important modifiable risk factor for poor outcome in pregnancy. AIM: To explore women's experiences of smoking during pregnancy, examine their attitudes and barriers to smoking cessation, and to discover what support they feel might enable them to have a smoke-free pregnancy in future. METHODS: A qualitative study was conducted with nineteen women in the United Kingdom who had smoked at some stage in pregnancy during the last five years. Data were collected through in-depth telephone interviews between June and August 2021. The interviews were audio-recorded, transcribed verbatim, and thematically analysed. FINDINGS: Four key themes were identified: the complex relationship with smoking, being ready to quit, the need for support and understanding, and ideas to support a smoke free pregnancy. The findings revealed that there were two distinct avenues for enabling the support process: encouraging a readiness to quit through identifying individual context, personalised support, and educational risk perception, and, supporting the process of quitting, and offering a range of options, underpinned by a personalised, non-judgemental approach. CONCLUSION: Smoking in pregnancy is a complex issue resulting from a combination of social, emotional, and physical factors. The findings from this study suggest that a combination of approaches should be made available to enable pregnant women who smoke to select the best options for their individual needs. Irrespective of the practical support offered, there is a need for informed, sensitive, individualised support system that women can identify with.

A better understanding of the association between maternal perception of foetal movements and late stillbirth-findings from an individual participant data meta-analysis.

BACKGROUND: Late stillbirth continues to affect 3-4/1000 pregnancies in high-resource settings, with even higher rates in low-resource settings. Reduced foetal movements are frequently reported by women prior to foetal death, but there remains a poor understanding of the reasons and how to deal with this symptom clinically, particularly during the preterm phase of gestation. We aimed to determine which women are at the greatest odds of stillbirth in relation to the maternal report of foetal movements in late pregnancy (≥ 28 weeks' gestation). METHODS: This is an individual participant data meta-analysis of all identified case-control studies of late stillbirth. Studies included in the IPD were two from New Zealand, one from Australia, one from the UK and an internet-based study based out of the USA. There were a total of 851 late stillbirths, and 2257 controls with ongoing pregnancies. RESULTS: Increasing strength of foetal movements was the most commonly reported (> 60%) pattern by women in late pregnancy, which were associated with a decreased odds of late stillbirth (adjusted odds ratio (aOR) = 0.20, 95% CI 0.15 to 0.27). Compared to no change in strength or frequency women reporting decreased frequency of movements in the last 2 weeks had increased odds of late stillbirth (aOR = 2.33, 95% CI 1.73 to 3.14). Interaction analysis showed increased strength of movements had a greater protective effect and decreased frequency of movements greater odds of late stillbirth at preterm gestations (28-36 weeks' gestation). Foetal hiccups (aOR = 0.45, 95% CI 0.36 to 0.58) and regular episodes of vigorous movement (aOR = 0.67, 95% CI 0.52 to 0.87) were associated with decreased odds of late stillbirth. A single episode of unusually vigorous movement was associated with increased odds (aOR = 2.86, 95% CI 2.01 to 4.07), which was higher in women at term. CONCLUSIONS: Reduced foetal movements are associated with late stillbirth, with the association strongest at preterm gestations. Foetal hiccups and multiple episodes of vigorous movements are reassuring at all gestations after 28 weeks' gestation, whereas a single episode of vigorous movement is associated with stillbirth at term.

Maternal mental health and infant and young child undernutrition: protocol for a systematic review.

INTRODUCTION: Mental health disorder, particularly depression, is one of the leading causes of 'disease related disability' in women that both affects the women but has adverse effect on their children. This can have an impact on mothers' capacity of child care which ultimately increases the risk of infection, malnutrition, impaired growth and behavioural problems in children that might extend to adulthood too. Diminished child growth has an irreversible effect both short and long terms, affecting physical growth, brain development, performance in education, working capacity and increased risks to non-communicable diseases. To date, the reviews conducted are only limited to few countries or maternal depression or certain age group of children. Our aim is to provide a global perspective focusing on all early childhood undernutrition (under 5 years) and to see if the association between maternal mental health and child undernutrition has yielded similar or different result. Furthermore, we intend to explore the risk factors associated with copresence of maternal mental health issues and undernutrition in children. METHODS AND ANALYSIS: MEDLINE (PubMed), PsycINFO, CINAHL, Cochrane Library, Global Health Library Relevant reports from the WHO, United Nations of Children Education Fund and organisations working in maternal and child health will also be searched. Database of systematic reviews and database of abstracts of reviews of effects will also be searched for relevant literature. Papers published from 1995 to 2020 in English will be included. Title, abstract or both will be screened independently by reviewers. For data analysis and synthesis, we will present all the outcomes mentioned in the studies and a subgroup analysis for age and sex will be conducted. This study aims to conduct a meta-analysis. ETHICS AND DISSEMINATION: Ethical approval is not required to conduct this review. PROSPERO REGISTRATION NUMBER: CRD42020189315.

An exploration of migrant women's perceptions of public health messages to reduce stillbirth in the UK: a qualitative study.

BACKGROUND: Stillbirth is a global public health priority. Within the United Kingdom, perinatal mortality disproportionately impacts Black, Asian and minority ethnic women, and in particular migrant women. Although the explanation for this remains unclear, it is thought to be multidimensional. Improving perinatal mortality is reliant upon raising awareness of stillbirth and its associated risk factors, as well as improving maternity services. The aim of this study was to explore migrant women's awareness of health messages to reduce stillbirth risk, and how key public health messages can be made more accessible. METHOD: Two semi-structured focus groups and 13 one to one interviews were completed with a purposive sample of 30 migrant women from 18 countries and across 4 NHS Trusts. RESULTS: Participants provided an account of their general awareness of stillbirth and recollection of the advice they had been given to reduce the risk of stillbirth both before and during pregnancy. They also suggested approaches to how key messages might be more effectively communicated to migrant women. CONCLUSIONS: Our study highlights the complexity of discussing stillbirth during pregnancy. The women in this study were found to receive a wide range of advice from family and friends as well as health professionals about how to keep their baby safe in pregnancy, they recommended the development of a range of resources to provide clear and consistent messages. Health professionals, in particular midwives who have developed a trusting relationship with the women will be key to ensuring that public health messages relating to stillbirth reduction are accessible to culturally and linguistically diverse communities.

Women's sleep position during pregnancy in low- and middle-income countries: a systematic review.

BACKGROUND: Approximately 2.6 million babies are stillborn each year globally, of which 98% occur in low- and middle-income countries (LMICs). A 2019 individual participant data meta-analysis of 6 studies from high-income countries found that maternal supine going-to-sleep position increased the risk of stillbirth. It is not clear whether this impact would be the same in LMICs, and the normal sleep behaviour of pregnant women in LMICs is not well understood. OBJECTIVE: Determine the prevalence of different sleeping positions among pregnant women in LMICs, and what (if any) positions were associated with stillbirth using a systematic review. SEARCH STRATEGY: We systematically searched the databases Medline, Embase, Emcare, CINAHL and Global Index Medicus for relevant studies, with no date or language restrictions on 4 April 2020. Reference lists of included studies were also screened. SELECTION CRITERIA: Observational studies of maternal sleep position during pregnancy in LMICs DATA COLLECTION AND ANALYSIS: Recovered citations were screened and eligible studies were included for extraction. These steps were performed by two independent reviewers. Risk of bias was assessed using the Newcastle-Ottawa Scale. MAIN RESULTS: A total of 3480 citations were screened but only two studies met the inclusion criteria. The studies were conducted in Ghana and India and reported on different maternal sleep positions: supine and left lateral. In Ghana, a prevalence of 9.7% for supine sleeping position amongst 220 women was found. The primary outcome could not be extracted from the Indian study as sleep position information was only reported for women who had a stillbirth (100 of the 300 participants). CONCLUSION: There is limited information on maternal sleeping position in LMICs. Since sleep position may be a modifiable risk factor for stillbirth, there is a need for further research to understand the sleep practices and behaviours of pregnant women in LMICs. PROSPERO registration: CRD42020173314.

Associations between consumption of coffee and caffeinated soft drinks and late stillbirth-Findings from the Midland and North of England stillbirth case-control study.

OBJECTIVE: The consumption of caffeinated drinks and soft drinks is widespread in society, including by pregnant women. Data regarding the association of caffeine intake and stillbirth are varied. We aimed to investigate the degree of consumption of caffeinated drinks or soft drinks in the last four weeks of pregnancy in women who experienced a late stillbirth compared to women with ongoing live pregnancies at similar gestation. Influences on maternal caffeine intake and soft drink consumption during pregnancy were also investigated. STUDY DESIGN: A case-control study undertaken in 41 maternity units in the United Kingdom. Cases were women who had a singleton non-anomalous stillbirth ≥28 weeks' gestation (n = 290) and controls were women with an ongoing pregnancy at the time of interview (n = 729). Data were collected using an interviewer-administered questionnaire which included questions regarding consumption of a variety of caffeinated drinks and soft drinks in the last four weeks of pregnancy as well as other behaviours (e.g. cigarette smoking). RESULTS: Multivariable analysis adjusting for co-existing demographic and behavioural factors found the consumption of instant coffee, energy drinks and cola were associated with increased risk of stillbirth. There was an independent association between caffeine intake and late stillbirth (adjusted Odds Ratio 1.27, 95 % Confidence Interval (95 %CI) 1.14, 1.43 for each 100 mg increment/day). 15 % of cases and 8% of controls consumed more than the World Health Organisation (WHO) recommendation (>300 mg of caffeine/day; aOR 2.30, 95 % CI 1.40, 4.24). The population attributable risk for stillbirth associated with >300 mg of caffeine/day was 7.4 %. The majority of respondents reduced caffeine consumption in pregnancy. Midwives and internet resources were the most frequently used sources of information which influenced maternal behaviour with regard to soft drinks and caffeine, and this did not differ between cases and controls. CONCLUSIONS: Women should be informed that consumption of caffeine during pregnancy is associated with increased risk of stillbirth, particularly at levels greater than recommended by the WHO (>300 mg/day). Recommendations from midwives and internet-based resources are likely to be the most effective means to influence maternal behaviour.

The Co-development and Feasibility-Testing of an Innovative Digital Animation Intervention (DAISI) to Reduce the Risk of Maternal Sepsis in the Postnatal Period.

INTRODUCTION: Sepsis is one of the most common causes of mortality in postnatal women globally and many other women who develop sepsis are left with severe morbidity. Women's knowledge of postnatal sepsis and how it can be prevented by simple changes to behaviour is lacking. METHODS: This paper describes the co-development and feasibility testing of a digital animation intervention called DAISI (digital animation in service improvement). This DAISI is designed to enhance postnatal women's awareness of sepsis and how to reduce their risk of developing the condition. We co-designed the digital animation over a six-month period underpinned by theory, best evidence and key stakeholders, translated it into Urdu then assessed its use, firstly in a focus group with women from different Black, Asian and Minority Ethnic (BAME) groups and secondly with 15 clinical midwives and 15 women (including BAME women). Following exposure to the intervention, midwives completed a questionnaire developed from the COM-B behaviour change model and women participated in individual and focus group interviews using similar questions. RESULTS: The animation was considered acceptable, culturally sensitive and simple to implement and follow. DISCUSSION: DAISI appears to be an innovative solution for use in maternity care to address difficulties with the postnatal hospital discharge process. We could find no evidence of digital animation being used in this context and recommend a study to test it in practice prior to adopting its use more widely. If effective, the DAISI principle could be used in other maternity contexts and other areas of the NHS to communicate health promotion information.

Associations between symptoms of sleep-disordered breathing and maternal sleep patterns with late stillbirth: Findings from an individual participant data meta-analysis.

BACKGROUND AND OBJECTIVES: Sleep-disordered breathing (SDB) affects up to one third of women during late pregnancy and is associated with adverse pregnancy outcomes, including hypertension, diabetes, impaired fetal growth, and preterm birth. However, it is unclear if SDB is associated with late stillbirth (≥28 weeks' gestation). The aim of this study was to investigate the relationship between self-reported symptoms of SDB and late stillbirth. METHODS: Data were obtained from five case-control studies (cases 851, controls 2257) from New Zealand (2 studies), Australia, the United Kingdom, and an international study. This was a secondary analysis of an individual participant data meta-analysis that investigated maternal going-to-sleep position and late stillbirth, with a one-stage approach stratified by study and site. Inclusion criteria: singleton, non-anomalous pregnancy, ≥28 weeks' gestation. Sleep data ('any' snoring, habitual snoring ≥3 nights per week, the Berlin Questionnaire [BQ], sleep quality, sleep duration, restless sleep, daytime sleepiness, and daytime naps) were collected by self-report for the month before stillbirth. Multivariable analysis adjusted for known major risk factors for stillbirth, including maternal age, body mass index (BMI kg/m2), ethnicity, parity, education, marital status, pre-existing hypertension and diabetes, smoking, recreational drug use, baby birthweight centile, fetal movement, supine going-to-sleep position, getting up to use the toilet, measures of SDB and maternal sleep patterns significant in univariable analysis (habitual snoring, the BQ, sleep duration, restless sleep, and daytime naps). Registration number: PROSPERO, CRD42017047703. RESULTS: In the last month, a positive BQ (adjusted odds ratio [aOR] 1.44, 95% confidence interval [CI] 1.02-2.04), sleep duration >9 hours (aOR 1.82, 95% CI 1.14-2.90), daily daytime naps (aOR 1.52, 95% CI 1.02-2.28) and restless sleep greater than average (aOR 0.62, 95% CI 0.44-0.88) were independently related to the odds of late stillbirth. 'Any' snoring, habitual snoring, sleep quality, daytime sleepiness, and a positive BQ excluding the BMI criterion, were not associated. CONCLUSION: A positive BQ, long sleep duration >9 hours, and daily daytime naps last month were associated with increased odds of late stillbirth, while sleep that is more restless than average was associated with reduced odds. Pregnant women may be reassured that the commonly reported restless sleep of late pregnancy may be physiological and associated with a reduced risk of late stillbirth.

Association of Supine Going-to-Sleep Position in Late Pregnancy With Reduced Birth Weight: A Secondary Analysis of an Individual Participant Data Meta-analysis.

Importance: Supine maternal position in the third trimester is associated with reduced uterine blood flow and increased risk of late stillbirth. As reduced uterine blood flow is also associated with fetal growth restriction, this study explored the association between the position in which pregnant women went to sleep and infant birth weight. Objective: To examine the association between supine position when going to sleep in women after 28 weeks of pregnancy and lower birth weight and birth weight centiles. Design, Setting, and Participants: Prespecified subgroup analysis using data from controls in an individual participant data meta-analysis of 4 case-control studies investigating sleep and stillbirth in New Zealand, Australia, and the United Kingdom. Participants were women with ongoing pregnancies at 28 weeks' gestation or more at interview. Main Outcomes and Measures: The primary outcome was adjusted mean difference (aMD) in birth weight. Secondary outcomes were birth weight centiles (INTERGROWTH-21st and customized) and adjusted odds ratios (aORs) for birth weight less than 50th and less than 10th centile (small for gestational age) for supine vs nonsupine going-to-sleep position in the last 1 to 4 weeks, adjusted for variables known to be associated with birth size. Results: Of 1760 women (mean [SD] age, 30.25 [5.46] years), 57 (3.2%) reported they usually went to sleep supine during the previous 1 to 4 weeks. Adjusted mean (SE) birth weight was 3410 (112) g among women who reported supine position and 3554 (98) g among women who reported nonsupine position (aMD, 144 g; 95% CI, -253 to -36 g; P = .009), representing an approximate 10-percentile reduction in adjusted mean INTERGROWTH-21st (48.5 vs 58.6; aMD, -10.1; 95% CI, -17.1 to -3.1) and customized (40.7 vs 49.7; aMD, -9.0; 95% CI, -16.6 to -1.4) centiles. There was a nonsignificant increase in birth weight at less than the 50th INTERGROWTH-21st centile (aOR, 1.90; 95% CI, 0.83-4.34) and a 2-fold increase in birth weight at less than the 50th customized centile (aOR, 2.12; 95% CI, 1.20-3.76). Going to sleep supine was associated with a 3-fold increase in small for gestational age birth weight by INTERGROWTH-21st standards (aOR, 3.23; 95% CI, 1.37-7.59) and a nonsignificant increase in small for gestational age birth weight customized standards (aOR, 1.63; 95% CI, 0.77-3.44). Conclusions and Relevance: This study found that going to sleep in a supine position in late pregnancy was independently associated with reduced birth weight and birth weight centile. This novel association is biologically plausible and likely modifiable. Public health campaigns that encourage women in the third trimester of pregnancy to settle to sleep on their side have potential to optimize birth weight.

An Individual Participant Data Meta-analysis of Maternal Going-to-Sleep Position, Interactions with Fetal Vulnerability, and the Risk of Late Stillbirth.

BACKGROUND: Maternal supine going-to-sleep position has been associated with increased risk of late stillbirth (≥ 28 weeks), but it is unknown if the risk differs between right and left side, and if some pregnancies are more vulnerable. METHODS: Systematic searches were undertaken for an individual-level participant data (IPD) meta-analysis of case-control studies, prospective cohort studies and randomised trials undertaken up until 26 Jan, 2018, that reported data on maternal going-to-sleep position and stillbirth. Participant inclusion criteria included gestation ≥ 28 weeks', non-anomalous, singleton pregnancies. The primary outcome was stillbirth. A one-stage approach stratified by study and site was used for the meta-analysis. The interaction between supine going-to-sleep position and fetal vulnerability was assessed by bi-variable regression. The multivariable model was adjusted for a priori confounders. Registration number: PROSPERO, CRD42017047703. FINDINGS: Six case-control studies were identified, with data obtained from five (cases, n = 851; controls, n = 2257). No data was provided by a sixth study (cases, n = 100; controls, n = 200). Supine going-to-sleep position was associated with increased odds of late stillbirth (adjusted odds ratio [aOR] 2.63, 95% CI 1.72-4.04, p < 0.0001) compared with left side. Right side had similar odds to left (aOR 1.04, 95% CI 0.83-1.31, p = 0.75). There were no significant interactions between supine going-to-sleep position and assessed indicators of fetal vulnerability, including small-for-gestational-age infants (p = 0.32), maternal obesity (p = 0.08), and smoking (p = 0.86). The population attributable risk for supine going-to-sleep position was 5.8% (3.2-9.2). INTERPRETATION: This IPD meta-analysis confirms that supine going-to-sleep position is independently associated with late stillbirth. Going-to-sleep on left or right side appears equally safe. No significant interactions with our assessed indicators of fetal vulnerability were identified, therefore, supine going-to-sleep position can be considered a contributing factor for late stillbirth in all pregnancies. This finding could reduce late stillbirth by 5.8% if every pregnant woman ≥ 28 weeks' gestation settled to sleep on her side.

Maternal sleep practices and stillbirth: Findings from an international case-control study.

BACKGROUND: Late stillbirth, which occurs ≥28 weeks' gestation, affects 1.3-8.8 per 1000 births in high-income countries. Of concern, most occur in women without established risk factors. Identification of potentially modifiable risk factors that relate to maternal behaviors remains a priority in stillbirth prevention research. This study aimed to investigate, in an international cohort, whether maternal sleep practices are related to late stillbirth. METHODS: An Internet-based case-control study of women who had a stillbirth ≥28 weeks' gestation within 30 days before completing the survey (n = 153) and women with an ongoing third-trimester pregnancy or who had delivered a live born child within 30 days (n = 480). Bivariate and multivariate logistic regressions were used to determine unadjusted and adjusted odds ratios (OR and aOR, respectively) with 95% confidence intervals (95% CIs) for stillbirth. RESULTS: Sleeping >9 hours per night in the previous month was associated with stillbirth (aOR 1.75 [95% CI 1.10-2.79]), as was waking on the right side (2.27 [1.31-3.92]). Nonrestless sleep in the last month was also found to be associated with stillbirth (1.73 [1.03-2.99]), with good sleep quality in the last month approaching significance (1.64 [0.98-2.75]). On the last night of pregnancy, not waking more than one time was associated with stillbirth (2.03 [1.24-3.34]). No relationship was found with going to sleep position during pregnancy, although very few women reported settling in the supine position (2.4%). CONCLUSIONS: Long periods of undisturbed sleep are associated with late stillbirth. Physiological studies of how the neuroendocrine and autonomic system pathways are regulated during sleep in the context of late pregnancy are warranted.

Women's experiences of being invited to participate in a case-control study of stillbirth - findings from the Midlands and North of England Stillbirth Study.

BACKGROUND: The Midlands and North of England Stillbirth Study (MiNESS) was a case-control study of women who had a stillbirth or who had an ongoing pregnancy. During the set up phase questions were raised about whether interviewing women within six weeks of a stillbirth and recruiting women who were still pregnant into a "stillbirth" study was acceptable. This led to the research questions "whether it is appropriate to ask women who have recently experienced a stillbirth to participate in research?" and "whether it is appropriate to ask pregnant women to participate in a research project looking at factors associated with stillbirth." This nested study aimed to describe the opinions of women approached to participate in MiNESS to explore their views and experiences of a research project focussed on stillbirth. METHODS: Semi- structured interviews were conducted at a single study site involved in MiNESS. Purposive sampling was used to obtain a sample of women who were approached following a stillbirth (case n = 6) and those who were approached during pregnancy who gave birth to a live born baby (control n = 6). These two groups of women were divided equally according to whether they participated in the main MiNESS questionnaire study and those who declined to do so (n = 3 in each group). Interview data were transcribed and analysed using thematic analysis to identify the most important factors in determining whether women participated in MiNESS. RESULTS: The following themes emerged from the analysis: participants' understanding of research; approach by researcher; wanting to help; stillbirth taboo. These themes are explored individually in the manuscript. Participants reported positive views about research and previous participation in research studies. Respondents valued an initial approach from a member of staff already known to them. The taboo around stillbirth was a barrier to participation for some women with ongoing pregnancies. CONCLUSIONS: Experiences and views regarding research differed between participants and non-participants in the MiNESS study. Participants reported a greater understanding of the importance and implications of clinical research. When designing future studies, the timing of approach, clarity of information and the person approaching potential participants should be considered to optimise recruitment. TRIAL REGISTRATION: NCT02025530 date registered: 01/01/2014.

Alterations in maternally perceived fetal movement and their association with late stillbirth: findings from the Midland and North of England stillbirth case-control study.

OBJECTIVE: To report perception of fetal movements in women who experienced a stillbirth compared with controls at a similar gestation with a live birth. DESIGN: Case-control study. SETTING: 41 maternity units in the UK. PARTICIPANTS: Cases were women who had a late stillbirth ≥28 weeks gestation (n=291) and controls were women with an ongoing pregnancy at the time of the interview (n=733). Controls were frequency matched to cases by obstetric unit and gestational age. METHODS: Data were collected using an interviewer-administered questionnaire which included questions on maternal perception of fetal movement (frequency, strength, increased and decreased movements and hiccups) in the 2 weeks before the interview/stillbirth. Five fetal movement patterns were identified incorporating the changes in strength and frequency in the last 2 weeks by combining groups of similar pattern and risk. Multivariable analysis adjusted for known confounders. PRIMARY OUTCOME MEASURE: Association of maternally perceived fetal movements in relation to late stillbirth. RESULTS: In multivariable analyses, women who reported increased strength of movements in the last 2 weeks had decreased risk of late stillbirth compared with those whose movements were unchanged (adjusted OR (aOR) 0.18, 95% CI 0.13 to 0.26). Women with decreased frequency (without increase in strength) of fetal movements were at increased risk (aOR 4.51, 95% CI 2.38 to 8.55). Daily perception of fetal hiccups was protective (aOR 0.31, 95% CI 0.17 to 0.56). CONCLUSIONS: Increased strength of fetal movements and fetal hiccups is associated with decreased risk of stillbirth. Alterations in frequency of fetal movements are important in identifying pregnancies at increased risk of stillbirth, with the greatest risk in women noting a reduction in fetal activity. Clinical guidance should be updated to reflect that increase in strength and frequency of fetal movements is associated with the lowest risk of stillbirth, and that decreased fetal movements are associated with stillbirth. TRIAL REGISTRATION NUMBER: NCT02025530.

"They told me all mothers have worries", stillborn mother's experiences of having a 'gut instinct' that something is wrong in pregnancy: Findings from an international case-control study.

OBJECTIVE: To describe and explore 'gut instinct' that something was wrong in women who identified that they experienced gut instinct during pregnancy. METHOD: A case-control study utilising an international web-based questionnaire. Stillborn cases (n = 146) and liveborn controls (n = 234) answered the gut instinct question within 30 days of the pregnancy ending. Of those, 84 cases and 27 controls also provided qualitative comment data. Descriptive statistics were used for the question, with a fixed option and summative content analysis was used to analyse the comment data. FINDINGS: In all, 110 (75%) of the stillborn cases answered "yes" to the gut instinct question vs only 28 (12%) of the controls who had a livebirth meaning the risk of stillbirth was 22.5 fold higher in those who experience "gut instinct" than in those who do not experience this feeling. Four themes were identified from the comment data namely: When the gut instinct occurred; How the gut instinct made the woman feel; Dreams and other related phenomena; Reassured by someone or something. CONCLUSIONS: Women who had a stillborn baby reported a "gut instinct" that something was wrong more frequently than mothers of a live born baby. Our findings may be influenced by recall negativity bias, and a prospective study is needed to confirm or refute our findings. The possibility that "maternal intuition" exists during pregnancy and responds to changes in fetal or placental health merits further exploration. IMPLICATIONS FOR PRACTICE: Maternity care providers should be alert to the woman when she expresses intuitive feelings, as well as asking her to report her concerns and act appropriately to assess and manage fetal wellbeing.

The Collaborative IPD of Sleep and Stillbirth (Cribss): is maternal going-to-sleep position a risk factor for late stillbirth and does maternal sleep position interact with fetal vulnerability? An individual participant data meta-analysis study protocol.

INTRODUCTION: Accumulating evidence has shown an association between maternal supine going-to-sleep position and stillbirth in late pregnancy. Advising women not to go-to-sleep on their back can potentially reduce late stillbirth rate by 9%. However, the association between maternal right-sided going-to-sleep position and stillbirth is inconsistent across studies. Furthermore, individual studies are underpowered to investigate interactions between maternal going-to-sleep position and fetal vulnerability, which is potentially important for producing clear and tailored public health messages on safe going-to-sleep position. We will use individual participant data (IPD) from existing studies to assess whether right-side and supine going-to-sleep positions are independent risk factors for late stillbirth and to test the interaction between going-to-sleep position and fetal vulnerability. METHODS AND ANALYSIS: An IPD meta-analysis approach will be used using the Cochrane Collaboration-endorsed methodology. We will identify case-control and prospective cohort studies and randomised trials which collected maternal going-to-sleep position data and pregnancy outcome data that included stillbirth. The primary outcome is stillbirth. A one stage procedure meta-analysis, stratified by study with adjustment of a priori confounders will be carried out. ETHICS AND DISSEMINATION: The IPD meta-analysis has obtained central ethics approval from the New Zealand Health and Disability Ethics Committee, ref: NTX/06/05/054/AM06. Individual studies should also have ethical approval from relevant local ethics committees. Interpretation of the results will be discussed with consumer representatives. Results of the study will be published in peer-reviewed journals and presented at international conferences. PROSPERO REGISTRATION NUMBER: CRD42017047703.