Maternity healthcare professionals' experiences of supporting women in decision-making for labour and birth: a qualitative study.

OBJECTIVES: To explore and characterise maternity healthcare professionals' (MHCPs) experience and practice of shared decision-making (SDM), to inform policy, research and practice development. DESIGN: Qualitative focus group study. SETTING: Large Maternity Unit in the Southwest of England. PARTICIPANTS: MHCPs who give information relating to clinical procedures and pregnancy care relating to labour and birth and are directly involved in decision-making conversations were purposively sampled to ensure representation across MHCP groups. DATA COLLECTION: A semistructured topic guide was used. DATA ANALYSIS: Reflexive thematic analysis was undertaken. RESULTS: Seven focus groups were conducted, comprising a total of 24 participants (3-5 per group). Two themes were developed: contextualising decision-making and controversies in current decision-making. Contextual factors that influenced decision-making practices included lack of time and challenges faced in intrapartum care. MHCPs reported variation in how they approach decision-making conversations and asked for more training on how to consistently achieve SDM. There were communication challenges with women who did not speak English. Three controversies were explored: the role of prior clinical experience, the validity of informed consent when women were in pain and during life-threatening emergencies and instances where women declined medical advice. CONCLUSIONS: We found that MHCPs are committed to SDM but need better support to deliver it. Structured processes including Core Information Sets, communication skills training and decision support aids may help to consistently deliver SDM in maternity care.

Exposure to microplastics and human reproductive outcomes: A systematic review.

BACKGROUND: Microplastics, produced through degradation of environmental plastic pollution, have been detected in human tissues including placenta and fetal meconium. Cell culture and animal studies have demonstrated potential reproductive toxicity of these particles; however, their association with adverse fertility or pregnancy outcomes in humans is not known. OBJECTIVES: To synthesise evidence for the presence of microplastics in human reproductive tissue and their associations with environmental exposures and reproductive outcomes. SEARCH STRATEGY: MEDLINE, Embase, Emcare, CINAHL, ClinicalTrials.gov and ICTRP were searched from inception to 03/02/2023. SELECTION CRITERIA: Studies of human participants, assessing presence of microplastics in reproductive tissues, environmental exposures to microplastics, and fertility- or pregnancy-related outcomes. DATA COLLECTION AND ANALYSIS: Two independent reviewers selected studies and extracted data on study characteristics, microplastics detected, environmental exposures and reproductive outcomes. Narrative synthesis was performed due to methodological heterogeneity. MAIN RESULTS: Of 1094 citations, seven studies were included, covering 96 participants. Microplastics composed of 16 different polymer types were detected in both placental and meconium samples. Two studies reported associations between lifestyle factors (daily water intake, use of scrub cleanser or toothpaste, bottled water and takeaway food) and placental microplastics. One study reported associations between meconium microplastics and reduced microbiota diversity. One reported placental microplastic levels correlated with reduced birthweights and 1-minute Apgar scores. CONCLUSIONS: There is a need for high-quality observational studies to assess the effects of microplastics on human reproductive health.

Omega-3 fatty acid supply in pregnancy for risk reduction of preterm and early preterm birth.

This clinical practice guideline on the supply of the omega-3 docosahexaenoic acid and eicosapentaenoic acid in pregnant women for risk reduction of preterm birth and early preterm birth was developed with support from several medical-scientific organizations, and is based on a review of the available strong evidence from randomized clinical trials and a formal consensus process. We concluded the following. Women of childbearing age should obtain a supply of at least 250 mg/d of docosahexaenoic+eicosapentaenoic acid from diet or supplements, and in pregnancy an additional intake of ≥100 to 200 mg/d of docosahexaenoic acid. Pregnant women with a low docosahexaenoic acid intake and/or low docosahexaenoic acid blood levels have an increased risk of preterm birth and early preterm birth. Thus, they should receive a supply of approximately 600 to 1000 mg/d of docosahexaenoic+eicosapentaenoic acid, or docosahexaenoic acid alone, given that this dosage showed significant reduction of preterm birth and early preterm birth in randomized controlled trials. This additional supply should preferably begin in the second trimester of pregnancy (not later than approximately 20 weeks' gestation) and continue until approximately 37 weeks' gestation or until childbirth if before 37 weeks' gestation. Identification of women with inadequate omega-3 supply is achievable by a set of standardized questions on intake. Docosahexaenoic acid measurement from blood is another option to identify women with low status, but further standardization of laboratory methods and appropriate cutoff values is needed. Information on how to achieve an appropriate intake of docosahexaenoic acid or docosahexaenoic+eicosapentaenoic acid for women of childbearing age and pregnant women should be provided to women and their partners.

Impact of COVID-19 on gestational diabetes pregnancy outcomes in the UK: A multicentre retrospective cohort study.

OBJECTIVE: To determine the impact of implementing emergency care pathway(s) for screening, diagnosing and managing women with gestational diabetes (GDM) during COVID-19. DESIGN: Retrospective multicentre cohort. SETTING: Nine National Health Service (NHS) Hospital Trusts/Health boards in England and Scotland. POPULATION: 4915 women with GDM pre-pandemic (1 April 2018 to 31 March 2020), and 3467 women with GDM during the pandemic (1 May 2020 to 31 March 2021). METHODS: We examined clinical outcomes for women with GDM prior to and during the pandemic following changes in screening methods, diagnostic testing, glucose thresholds and introduction of virtual care for monitoring of antenatal glycaemia. MAIN OUTCOME MEASURES: Intervention at birth, perinatal mortality, large-for-gestational-age infants and neonatal unit admission. RESULTS: The new diagnostic criteria more often identified GDM women who were multiparous, had higher body mass index (BMI) and greater deprivation, and less frequently had previous GDM (all p < 0.05). During COVID, these women had no differences in the key outcome measures. Of the women, 3% were identified with pre-existing diabetes at antenatal booking. Where OGTT continued during COVID, but virtual care was introduced, outcomes were also similar pre- and during the pandemic. CONCLUSIONS: Using HbA1c and fasting glucose identified a higher risk GDM population during the pandemic but this had minimal impact on pregnancy outcomes. The high prevalence of undiagnosed pre-existing diabetes suggests that women with GDM risk factors should be offered HbA1c screening in early pregnancy.

Implementing weight management during and after pregnancy to reduce diabetes and CVD risk in maternal and child populations.

Maintaining a healthy weight during pregnancy is critical for both women's and children's health. Excessive gestational weight gain (GWG) can lead to complications such as gestational diabetes, hypertension and caesarean delivery. Insufficient GWG can cause fetal growth restriction and increase infant mortality risk. Additionally, postpartum weight retention raises risk of obesity, type 2 diabetes and other chronic diseases for both mother and child. This review seeks to identify current obstacles in weight management research during and after pregnancy and explore evidence-based strategies to overcome them. Pregnancy offers a window of opportunity for health behaviour changes as women are more receptive to education and have regular contact with health services. Staying within Institute of Medicine's recommended GWG ranges is associated with better maternal and fetal outcomes. Systematic review evidence supports structured diet and physical activity pregnancy interventions, leading to reduced GWG and fewer complications. Health economic evaluation indicates significant returns from implementation, surpassing investment costs due to decreased perinatal morbidity and adverse events. However, the most effective way to implement interventions within routine antenatal care remains unclear. Challenges increase in the postpartum period due to competing demands on women physically, mentally and socially, hindering intervention reach and retention. Flexible, technology-supported interventions are needed, requiring frameworks such as penetration-implementation-participation-effectiveness and template-for-intervention-description-and-replication for successful implementation. Greater research efforts are necessary to inform practice and investigate fidelity aspects through pragmatic implementation trials during the pregnancy and postpartum periods. Understanding the best ways to deliver interventions will empower women to maintain a healthy weight during their reproductive years.

A Complex mHealth Coaching Intervention to Prevent Overweight, Obesity, and Diabetes in High-Risk Women in Antenatal Care: Protocol for a Hybrid Type 2 Effectiveness-Implementation Study.

BACKGROUND: Women with overweight and obesity are at higher risk of developing complications in pregnancy such as gestational diabetes and longer-term chronic conditions. Research concerning health behavior change interventions during pregnancy and postpartum shows promising effects, but implementation into routine services is sparsely investigated. Most interventions focus on the antenatal or postpartum life stages, failing to meet the needs of women. IMPACT DIABETES Bump2Baby is a multicenter project across 4 high-income countries developed to test the implementation of an antenatal and postpartum evidence-based mobile health (mHealth) coaching intervention called Bump2Baby and Me (B2B&Me) designed to sit alongside usual care in the perinatal period. OBJECTIVE: We aim to explore the feasibility and implementation of the B2B&Me intervention and investigate the effectiveness of this intervention in women at risk of gestational diabetes. METHODS: IMPACT DIABETES Bump2Baby is a hybrid type 2 effectiveness-implementation study, which integrates an evidence-based mHealth coaching app that includes personalized health behavior change coaching provided by health care professionals alongside antenatal care from the first antenatal visit to 12 months postpartum. The mHealth app offers the possibility of synchronous calls, asynchronous contact (including coach-participant text and video messaging exchanges tailored to the participant's needs), and ongoing access to an extensive library of bespoke intervention materials. Participants will interact asynchronously with their health coach throughout the intervention via the app. This randomized controlled trial across 4 clinical sites within Ireland, the United Kingdom, Spain, and Australia will recruit 800 women in early pregnancy to evaluate the effectiveness on postpartum weight. The Exploration, Preparation, Implementation, and Sustainment implementation framework is the theoretical underpinning of the study. The implementation evaluation will be assessed at the individual, hospital staff, and broader community levels using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Data sources for the RE-AIM evaluation will include app and platform analytics, screening and training records, participant medical records, key informant interviews, participant and partner exit interviews, cost data, study questionnaires, staff surveys, and blood sample analyses. RESULTS: The study was approved and registered with the Australian New Zealand Clinical Trials Registry on November 19, 2020. Recruitment commenced on February 9, 2021, and data collection is ongoing. Publication of the results is expected in 2024. CONCLUSIONS: This is the first hybrid effectiveness-implementation study of an 18-month mHealth coaching intervention in at-risk women that we are aware of. As research aims to move toward real-world implementable solutions, it is critical that hybrid studies are conducted. The data from this large multicenter study will be useful in planning the potential implementation and scale-up of evidence-based perinatal health behavior change interventions. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620001240932; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380020&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51431.

Vaginal birth core information set: study protocol for a Delphi study to achieve a consensus on a 'core information set' for vaginal birth.

INTRODUCTION: Studies have shown that women are often underinformed about potential benefits and risks of vaginal birth. This is in contrast to other modes of birth, such as caesarean birth, for which the risks/benefits are often conveyed prior to undergoing the procedure. A core information set (CIS) is an agreed set of information points that should be discussed with all patients prior to undergoing a procedure or intervention. This CIS could improve the quality of information given regarding mode of birth options, as women will be given information prioritised by patients and stakeholders regarding vaginal birth, empowering them to make informed decisions about their birth. We aim to describe the protocol for the development of this vaginal birth CIS. METHODS AND ANALYSIS: We will develop the CIS by: (1) Compiling a 'long-list' of information points about vaginal birth by: undertaking a scoping review of studies and patient information leaflets; interviews with antenatal/postnatal women, an online survey of stakeholders. (2) Collating the 'long-list' of information points and developing the Delphi survey. Think-aloud interviews will refine the survey. (3) Conducting a two-round Delphi survey. 200 stakeholder participants will be recruited. Items rated critically important by ≥80% of participants in one stakeholder group, or with no consensus, will be carried through to a stakeholder consensus meeting to decide the final CIS. Planned start date is 1 June 2022. Planned end date is 31 August 2023. ETHICS AND DISSEMINATION: This project has been given a favourable ethics opinion by the University of Bristol Research Ethics Committee (Ref: 10530). Approval from the ethics committee will be sought for any protocol amendments, and the principal investigator will be responsible for these changes. Findings will be presented at relevant conferences and published in a high-impact journal. We will disseminate the CIS, via Policy Bristol, to clinical policy and guideline developers.

Protocol for a multi-site randomised controlled feasibility study investigating intermittently scanned blood continuous glucose monitoring use for gestational diabetes: the RECOGNISE study.

BACKGROUND: Incidence of gestational diabetes mellitus (GDM) is increasing and is associated with adverse perinatal outcomes including macrosomia, pre-eclampsia, and pre-term delivery. Optimum glycaemic control can reduce these adverse perinatal outcomes. Continuous glucose monitoring (CGM) informs users about interstitial glucose levels allowing early detection of glycaemic excursions and pharmacological or behavioural intervention. Few adequately powered RCTs to evaluate the impact of using CGM in women with GDM on perinatal outcomes have been undertaken. We aim to establish the feasibility of a multi-site RCT to evaluate the clinical- and cost-effectiveness of an intermittently scanned continuous glucose monitor (isCGM) compared with self-monitored blood glucose (SMBG) in women with GDM for reducing fetal macrosomia and improving maternal and fetal outcomes. We will evaluate recruitment and retention rates, adherence to device requirements, adequacy of data capture and acceptability of trial design and isCGM devices. METHODS: Open-label multicentre randomised controlled feasibility trial. INCLUSION CRITERIA: pregnant women, singleton pregnancy, recent diagnosis of GDM (within 14 days of commencing medication, up to 34 weeks gestation) prescribed metformin and/or insulin. Women will be consecutively recruited and randomised to isCGM (FreestyleLibre2) or SMBG. At every antenatal visit, glucose measurements will be evaluated. The SMBG group will use blinded isCGM for 14 days at baseline (~ 12-32 weeks) and ~ 34-36 weeks. The primary outcome is the recruitment rate and absolute number of women participating. Clinical assessments of maternal and fetal/infant health will be undertaken at baseline, birth, up to ~ 13 weeks post-natal. Psychological, behavioural and health economic measures will be assessed at baseline and ~ 34-36 weeks gestation. Qualitative interviews will be undertaken with study decliners, participants, and professionals to explore trial acceptability, of using isCGM and SMBG. DISCUSSION: GDM can be associated with adverse pregnancy outcomes. isCGM could offer a timely, easy-to-engage-with intervention, to improve glycaemic control, potentially reducing adverse pregnancy, birth and long-term health outcomes for mother and child. This study will determine the feasibility of conducting a large-scale multisite RCT of isCGM in women with GDM. TRIAL REGISTRATION: This study has been registered with the ISRCTN (reference: ISRCTN42125256 , Date registered: 07/11/2022).

Maternal hemoglobin levels and adverse pregnancy outcomes: individual patient data analysis from 2 prospective UK pregnancy cohorts.

BACKGROUND: Hemoglobin (Hb) is a modifiable risk factor for adverse pregnancy outcomes. Studies have reported conflicting associations between maternal Hb levels and adverse pregnancy outcomes, including preterm birth (PTB), low birth weight (LBW), and perinatal mortality. OBJECTIVE: In this study, we aimed to estimate the shape and magnitude of associations between maternal Hb levels in early (7-12 wk gestation) and late pregnancy (27-32 wk gestation) and pregnancy outcomes in a high-income setting. METHODS: We used data from 2 UK population-based pregnancy cohorts: the Avon Longitudinal Study of Parents and Children (ALSPAC) and Pregnancy Outcome Prediction Study (POPS). We used multivariable logistic regression models to examine the relationship between Hb and pregnancy outcomes, adjusting for maternal age, ethnicity, BMI, smoking status, and parity. Main outcome measures were PTB, LBW, small for gestational age (SGA), pre-eclampsia (PET), and gestational diabetes mellitus (GDM). RESULTS: Mean Hb in ALSPAC were 12.5 g/dL (SD = 0.90) and 11.2 g/dL (SD = 0.92) in early and late pregnancy, respectively, and 12.7 g/dL (SD = 0.82) and 11.4 g/dL (SD = 0.82) in POPS. In the pooled analysis, there was no evidence of associations between a higher Hb in early pregnancy (7-12 wk gestation) and PTB (OR per 1 g/dL of Hb: 1.09; 95% CI: 0.97, 1.22), LBW (1.12: 0.99, 1.26), and SGA (1.06; 0.97, 1.15). Higher Hb in late pregnancy (27-32 wk gestation) was associated with PTB (1.45: 1.30, 1.62), LBW (1.77: 1.57, 2.01), and SGA (1.45: 1.33, 1.58). Higher Hb in early and late pregnancy was associated with PET in ALSPAC (1.36: 1.12, 1.64) and (1.53: 1.29, 1.82), respectively, but not in POPS (1.17:0.99, 1.37) and (1.03: 0.86, 1.23). There was an association with a higher Hb and GDM in ALSPAC in both early and late pregnancy [(1.51: 1.08, 2.11) and (1.35: 1.01, 1.79), respectively], but not in POPS [(0.98: 0.81, 1.19) and (0.83: 0.68, 1.02)]. CONCLUSIONS: Higher maternal Hb may identify the risk of adverse pregnancy outcomes. Further research is required to investigate if this association is causal and to identify the underlying mechanisms.

Interventions to enhance medication adherence in pregnancy- a systematic review.

BACKGROUND: Sub-optimal medication adherence in pregnant women with chronic disease and pregnancy-related indications has the potential to adversely affect maternal and perinatal outcomes. Adherence to appropriate medications is advocated during and when planning pregnancy to reduce risk of adverse perinatal outcomes relating to chronic disease and pregnancy-related indications. We aimed to systematically identify effective interventions to promote medication adherence in women who are pregnant or planning to conceive and impact on perinatal, maternal disease-related and adherence outcomes. METHODS: Six bibliographic databases and two trial registries were searched from inception to 28th April 2022. We included quantitative studies evaluating medication adherence interventions in pregnant women and women planning pregnancy. Two reviewers selected studies and extracted data on study characteristics, outcomes, effectiveness, intervention description (TIDieR) and risk of bias (EPOC). Narrative synthesis was performed due to study population, intervention and outcome heterogeneity. RESULTS: Of 5614 citations, 13 were included. Five were RCTs, and eight non-randomised comparative studies. Participants had asthma (n = 2), HIV (n = 6), inflammatory bowel disease (IBD; n = 2), diabetes (n = 2) and risk of pre-eclampsia (n = 1). Interventions included education +/- counselling, financial incentives, text messaging, action plans, structured discussion and psychosocial support. One RCT found an effect  of the tested intervention on self-reported antiretroviral adherence but not objective adherence. Clinical outcomes were not evaluated. Seven non-randomised comparative studies found an association between the tested intervention and at least one outcome of interest: four found an association between receiving the intervention and both improved clinical or perinatal outcomes and adherence in women with IBD, gestational diabetes mellitus (GDM), and asthma. One study in women with IBD reported an association between receiving the intervention and maternal outcomes but not for self-reported adherence. Two studies measured only adherence outcomes and reported an association between receiving the intervention and self-reported and/or objective adherence in women with HIV and risk of pre-eclampsia. All studies had high or unclear risk of bias. Intervention reporting was adequate for replication in two studies according to the TIDieR checklist. CONCLUSIONS: There is a need for high-quality RCTs reporting replicable interventions to evaluate medication adherence interventions in pregnant women and those planning pregnancy. These should assess both clinical and adherence outcomes.

Interventions, outcomes and outcome measurement instruments in stillbirth care research: A systematic review to inform the development of a core outcome set.

BACKGROUND: A core outcome set could address inconsistent outcome reporting and improve evidence for stillbirth care research, which have been identified as an important research priority. OBJECTIVES: To identify outcomes and outcome measurement instruments reported by studies evaluating interventions after the diagnosis of a stillbirth. SEARCH STRATEGY: Amed, BNI, CINAHL, ClinicalTrials.gov, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase, MEDLINE, PsycINFO, and WHO ICTRP from 1998 to August 2021. SELECTION CRITERIA: Randomised and non-randomised comparative or non-comparative studies reporting a stillbirth care intervention. DATA COLLECTION AND ANALYSIS: Interventions, outcomes reported, definitions and outcome measurement tools were extracted. MAIN RESULTS: Forty randomised and 200 non-randomised studies were included. Fifty-eight different interventions were reported, labour and birth care (52 studies), hospital bereavement care (28 studies), clinical investigations (116 studies), care in a multiple pregnancy (2 studies), psychosocial support (28 studies) and care in a subsequent pregnancy (14 studies). A total of 391 unique outcomes were reported and organised into 14 outcome domains: labour and birth; postpartum; delivery of care; investigations; multiple pregnancy; mental health; emotional functioning; grief and bereavement; social functioning; relationship; whole person; subsequent pregnancy; subsequent children and siblings and economic. A total of 242 outcome measurement instruments were used, with 0-22 tools per outcome. CONCLUSIONS: Heterogeneity in outcome reporting, outcome definition and measurement tools in care after stillbirth exists. Considerable research gaps on specific intervention types in stillbirth care were identified. A core outcome set is needed to standardise outcome collection and reporting for stillbirth care research.

Does provision of antenatal care in Southern Asia improve neonatal survival? A systematic review and meta-analysis.

BACKGROUND: Southern Asia has one of the highest burdens of neonatal mortality worldwide (26/1000 live births). Ensuring that women receive antenatal care from a skilled provider may play an important role in reducing this burden. OBJECTIVE: This study aimed to determine whether antenatal care received from a skilled provider could reduce neonatal mortality in Southern Asia by systematically reviewing existing evidence. STUDY DESIGN: Seven databases were searched (MEDLINE, Embase, Cochrane Library, CINAHL, PubMed, PsycINFO, and International Bibliography of the Social Sciences [IBSS]). The key words included: "neonatal mortality," "antenatal care," and "Southern Asia." Nonrandomized comparative studies conducted in Southern Asia reporting on neonatal mortality in women who received antenatal care compared with those who did not were included. Two authors carried out the screening and data extraction. The Risk of Bias Assessment tool for Non-randomized Studies (RoBANS) was used to assess quality of studies. Results were reported using a random-effects model based on odds ratios with 95% confidence intervals. RESULTS: Four studies were included in a meta-analysis of adjusted results. The pooled odds ratio was 0.46 (95% confidence interval, 0.24 to 0.86) for neonatal deaths among women having at least 1 antenatal care visit during pregnancy compared with women having none. In the final meta-analysis, 16 studies could not be included because of lack of adjustment for confounders, highlighting the need for further higher-quality studies to evaluate the true impact. CONCLUSION: This review suggests that in Southern Asia, neonates born to women who received antenatal care have a lower risk of death in the neonatal period compared with neonates born to women who did not receive antenatal care. This should encourage health policy to strengthen antenatal care programs in Southern Asia.

Antenatal care in Nepal: a qualitative study into missed opportunities in the first trimester.

BACKGROUND: Use of timely antenatal care has been identified as key to facilitating healthy pregnancies worldwide. Although considerable investment has been made to enhance maternal health services in Nepal, approximately one-third of women do not attend antenatal care until after the first trimester (late). These women miss out on the benefits of screening and interventions that are most effective in the first trimester. OBJECTIVE: This study aimed to identify the missed opportunities of women who do not attend antenatal care in the first trimester, and to explore some of the factors underlying late attendance and consider potential solutions for minimizing these missed opportunities in the future. STUDY DESIGN: This study was conducted in 3 hospitals in Nepal. Focus groups (n=18) with a total of 48 postnatal women and 49 staff members, and 10 individual interviews with stakeholders were conducted. Purposive sampling facilitated the obtainment of a full range of maternity experiences, staff categories, and stakeholder positions. Data were qualitative and analyzed using a thematic approach. RESULTS: Limited awareness among women of the importance of early antenatal care was reported as a key factor behind attendance only after the first trimester. The family and community were described as significant influencers in women's decision-making regarding the timing of antenatal care. The benefits of early ultrasound scanning and effective supplementation in pregnancy were the major missed opportunities. Increasing awareness, reducing cost, and enhancing interprofessional collaboration were suggested as potential methods for improving timely initiation of antenatal care. CONCLUSION: Limited awareness continues to drive late attendance to antenatal care after the first trimester. Investment in services in the first trimester and community health education campaigns are needed to improve this issue and enhance maternal and neonatal outcomes.

Temporal trends in stillbirth over eight decades in England and Wales: A longitudinal analysis of over 56 million births and lives saved by improvements in maternity care.

Background: Considering the public health importance of stillbirth, this study quantified the trends in stillbirths over eight decades in England and Wales. Methods: This longitudinal study utilized the publicly available aggregated data from the Office for National Statistics that captured maternity information for babies delivered in England and Wales from 1940 to 2019. We computed the trends in stillbirth with the associated incidence risk difference, incidence risk ratio, and extra lives saved per decade. Results: From 1940-2019, 56 906 273 births were reported. The stillbirth rate declined (85%) drastically up to the early 1980s. In the initial five decades, the estimated number of deaths per decade further decreased by 67 765 (9.49/1000 births) in 1940-1949, 2569 (0.08/1000 births) in 1950-1959, 9121 (3.50/1000 births) in 1960-1969, 15 262 (2.31/1000 births) in 1970-1979, and 10 284 (1.57/1000 births) in 1980-1989. However, the stillbirth rate increased by an additional 3850 (0.58/1000 births) stillbirths in 1990-1999 and 693 (0.11/1000 births) stillbirths in 2000-2009. The stillbirth rate declined again during 2010-2019, with 3714 fewer stillbirths (0.54/1000 births). The incidence of maternal age <20 years reduced over time, but pregnancy among older women (>35 years) increased. Conclusions: The stillbirth rate declined drastically, but the rate of decline slowed in the last three decades. Though teenage pregnancy (<20 years) had reduced, the prevalence of women with a higher risk of stillbirth may have risen due to an increase in advanced maternal age. Improved, more personalised care is required to reduce the stillbirth rate further.

The Tommy's Clinical Decision Tool, a device for reducing the clinical impact of placental dysfunction and preterm birth: protocol for a mixed-methods early implementation evaluation study.

BACKGROUND: Disparities in stillbirth and preterm birth persist even after correction for ethnicity and social deprivation, demonstrating that there is wide geographical variation in the quality of care. To address this inequity, Tommy's National Centre for Maternity Improvement developed the Tommy's Clinical Decision Tool, which aims to support the provision of "the right care at the right time", personalising risk assessment and care according to best evidence. This web-based clinical decision tool assesses the risk of preterm birth and placental dysfunction more accurately than current methods, and recommends best evidenced-based care pathways in a format accessible to both women and healthcare professionals. It also provides links to reliable sources of pregnancy information for women. The aim of this study is to evaluate implementation of Tommy's Clinical Decision Tool in four early-adopter UK maternity services, to inform wider scale-up. METHODS: The Tommy's Clinical Decision Tool has been developed involving maternity service users and healthcare professionals in partnership. This mixed-methods study will evaluate: maternity service user and provider acceptability and experience; barriers and facilitators to implementation; reach (whether particular groups are excluded and why), fidelity (degree to which the intervention is delivered as intended), and unintended consequences. Data will be gathered over 25 months through interviews, focus groups, questionnaires and through the Tommy's Clinical Decision Tool itself. The NASSS framework (Non-adoption or Abandonment of technology by individuals and difficulties achieving Scale-up, Spread and Sustainability) will inform data analysis. DISCUSSION: This paper describes the intervention, Tommy's Clinical Decision Tool, according to TiDIER guidelines, and the protocol for the early adopter implementation evaluation study. Findings will inform future scale up. TRIAL REGISTRATION: This study was prospectively registered on the ISRCTN registry no. 13498237 , on 31st January 2022.

A systematic review and narrative synthesis of antenatal interventions to improve maternal and neonatal health in Nepal.

BACKGROUND: Maternal and neonatal mortality rates remain high in many economically underdeveloped countries, including Nepal, and good quality antenatal care can reduce adverse pregnancy outcomes. However, identifying how to best improve antenatal care can be challenging. OBJECTIVE: To identify the interventions that have been investigated in the antenatal period in Nepal for maternal or neonatal benefit. We wanted to understand their scale, location, cost, and effectiveness. STUDY DESIGN: Online bibliographic databases (Cochrane Central, MEDLINE, Embase, CINAHL Plus, British Nursing Index, PsycInfo, Allied and Complementary Medicine) and trial registries (ClinicalTrials.gov and the World Health Organization Clinical Trials Registry Platform) were searched from their inception till May 24, 2020. We included all studies reporting any maternal or neonatal outcome after an intervention in the antenatal period. We screened the studies and extracted the data in duplicate. A meta-analysis was not possible because of the heterogeneity of the interventions and outcomes, so we performed a narrative synthesis of the included studies. RESULTS: A total of 25 studies met our inclusion criteria. These studies showed a variety of approaches toward improving antenatal care (eg, educational programs, incentive schemes, micronutrient supplementation) in different settings (home, community, or hospital-based) and with a wide variety of outcomes. Less than a quarter of the studies were randomized controlled trials, and many were single-site or reported only short-term outcomes. All studies reported having made a positive impact on antenatal care in some way, but only 3 provided a cost-benefit analysis to support implementation. None of these studies focused on the most remote communities in Nepal. CONCLUSION: Our systematic review found good quality evidence that micronutrient supplementation and educational interventions can bring important clinical benefits. Iron and folic acid supplementation significantly reduces neonatal mortality and maternal anemia, whereas birth preparedness classes increase the uptake of antenatal and postnatal care, compliance with micronutrient supplementation, and awareness of the danger signs in pregnancy.

Protocol for the development of a core outcome set for stillbirth care research (iCHOOSE Study).

INTRODUCTION: Stillbirth is associated with significant physical, psychosocial and economic consequences for parents, families, wider society and the healthcare system. There is emerging momentum to design and evaluate interventions for care after stillbirth and in subsequent pregnancies. However, there is insufficient evidence to inform clinical practice compounded by inconsistent outcome reporting in research studies. To address this paucity of evidence, we plan to develop a core outcome set for stillbirth care research, through an international consensus process with key stakeholders including parents, healthcare professionals and researchers. METHODS AND ANALYSIS: The development of this core outcome set will be divided into five distinct phases: (1) Identifying potential outcomes from a mixed-methods systematic review and analysis of interviews with parents who have experienced stillbirth; (2) Creating a comprehensive outcome long-list and piloting of a Delphi questionnaire using think-aloud interviews; (3) Choosing the most important outcomes by conducting an international two-round Delphi survey including high-income, middle-income and low-income countries; (4) Deciding the core outcome set by consensus meetings with key stakeholders and (5) Dissemination and promotion of the core outcome set. A parent and public involvement panel and international steering committee has been convened to coproduce every stage of the development of this core outcome set. ETHICS AND DISSEMINATION: Ethical approval for the qualitative interviews has been approved by Berkshire Ethics Committee REC Reference 12/SC/0495. Ethical approval for the think-aloud interviews, Delphi survey and consensus meetings has been awarded from the University of Bristol Faculty of Health Sciences Research Ethics Committee (Reference number: 116535). The dissemination strategy is being developed with the parent and public involvement panel and steering committee. Results will be published in peer-reviewed specialty journals, shared at national and international conferences and promoted through parent organisations and charities. PROSPERO REGISTRATION NUMBER: CRD42018087748.

Pharmacoepidemiology in pregnancy: analysis protocol for an observational cohort study in the UK Clinical Practice Research Datalink.

Large numbers of women take prescription and over-the-counter medications during pregnancy. However, there is very little definitive evidence about the potential effects of these drugs on the mothers and offspring. We will investigate the risks and benefits of continuing prescriptive drug use for chronic pre-existing maternal conditions such as diabetes, hypertension and thyroid related conditions throughout pregnancy. If left untreated, these conditions are established risk factors for adverse neonatal and maternal outcomes. However, some treatments for these conditions are associated with adverse neonatal outcomes. Our primary aims are twofold. Firstly, we aim to estimate the beneficial effect on the mother of continuing treatment during pregnancy. Second, we aim to determine whether there is an associated detrimental impact on the neonate of continuation of maternal treatment during pregnancy. To establish this evidence, we will investigate the relationship between maternal drug prescriptions and adverse and beneficial offspring outcomes to provide evidence to guide clinical decisions. We will conduct a hypothesis testing observational intergenerational cohort study using data from the UK Clinical Practice Research Datalink (CPRD). We will apply four statistical methods: multivariable adjusted regression, propensity score regression, instrumental variables analysis and negative control analysis. These methods should account for potential confounding when estimating the association between the drug exposure and maternal or neonatal outcome. In this protocol we describe the aims, motivation, study design, cohort and statistical analyses of our study to aid reproducibility and transparency within research.

Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children.

BACKGROUND: Gestational diabetes (GDM) impacts 8-18% of pregnancies and greatly increases both maternal and child risk of developing non-communicable diseases such as type 2 diabetes and obesity. Whilst lifestyle interventions in pregnancy and postpartum reduce this risk, a research translation gap remains around delivering implementable interventions with adequate population penetration and participation. Impact Diabetes Bump2Baby is an implementation project of an evidence-based system of care for the prevention of overweight and obesity. Bump2Baby and Me is the multicentre randomised controlled trial investigating the effectiveness of a mHealth coaching programme in pregnancy and postpartum for women at high risk of developing GDM. METHODS: Eight hundred women will be recruited in early pregnancy from 4 clinical sites within Ireland, the UK, Spain, and Australia. Women will be screened for eligibility using the validated Monash GDM screening tool. Participants will be enrolled from 12 to 24 weeks' gestation and randomised on a 1:1 basis into the intervention or control arm. Alongside usual care, the intervention involves mHealth coaching via a smartphone application, which uses a combination of synchronous and asynchronous video and text messaging, and allows for personalised support and goal setting with a trained health coach. The control arm receives usual care. All women and their children will be followed from early pregnancy until 12 months postpartum. The primary outcome will be a difference in maternal body mass index (BMI) of 0.8 kg/m2 at 12 months postpartum. Secondary maternal and infant outcomes include the development of GDM, gestational weight gain, pregnancy outcomes, improvements in diet, physical activity, sleep, and neonatal weight and infant growth patterns. The 5-year project is funded by the EU Commission Horizon 2020 and the Australian National Health and Medical Research Council. Ethical approval has been received. DISCUSSION: Previous interventions have not moved beyond tightly controlled efficacy trials into routine service delivery. This project aims to provide evidence-based, sustainable support that could be incorporated into usual care for women during pregnancy and postpartum. This study will contribute evidence to inform the early prevention of non-communicable diseases like obesity and diabetes in mothers and the next generation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620001240932 . Registered on 19 November 2020.

Parents' Active Role and ENgagement in The review of their Stillbirth/perinatal death 2 (PARENTS 2) study: a mixed-methods study of implementation.

OBJECTIVE: When a formal review of care takes places after the death of a baby, parents are largely unaware it takes place and are often not meaningfully involved in the review process. Parent engagement in the process is likely to be essential for a successful review and to improve patient safety. This study aimed to evaluate an intervention process of parental engagement in perinatal mortality review (PNMR) and to identify barriers and facilitators to its implementation. DESIGN: Mixed-methods study of parents' engagement in PNMR. SETTING: Single tertiary maternity unit in the UK. PARTICIPANTS: Bereaved parents and healthcare professionals (HCPs). INTERVENTIONS: Parent engagement in the PNMR (intervention) was based on principles derived through national consensus and qualitative research with parents, HCPs and stakeholders in the UK. OUTCOMES: Recruitment rates, bereaved parents and HCPs' perceptions. RESULTS: Eighty-one per cent of bereaved parents approached (13/16) agreed to participate in the study. Two focus groups with bereaved parents (n=11) and HCP (n=7) were carried out postimplementation to investigate their perceptions of the process.Overarching findings were improved dialogue and continuity of care with parents, and improvements in the PNMR process and patient safety. Bereaved parents agreed that engagement in the PNMR process was invaluable and helped them in their grieving. HCP perceived that parent involvement improved the review process and lessons learnt from the deaths; information to understand the impact of aspects of care on the baby's death were often only found in the parents' recollections. CONCLUSIONS: Parental engagement in the PNMR process is achievable and useful for parents and HCP alike, and critically can improve patient safety and future care for mothers and babies. To learn and prevent perinatal deaths effectively, all hospitals should give parents the option to engage with the review of their baby's death.