Obstetric care for environmental migrants.

BACKGROUND: Migration due to environmental factors is an international crisis affecting many nations globally. Pregnant people are a vulnerable subgroup of migrants. AIM: This article explores the potential effects of environmental migration on pregnancy and aims to draw attention to this rising concern. METHODS: Based on the study aim, a semi-structured literature review was performed. The following databases were searched: MEDLine (PubMed) and Google Scholar. The search was originally conducted on 31st January 2021 and repeated on 22nd September 2022. RESULTS: Pregnant migrants are at increased risk of mental health disorders, congenital anomalies, preterm birth, and maternal mortality. Pregnancies exposed to natural disasters are at risk of low birth weight, preterm birth, hypertensive disorders, gestational diabetes, and mental health morbidity. Along with the health risks, there are additional complex social factors affecting healthcare engagement in this population. CONCLUSION: Maternity healthcare providers are likely to provide care for environmental migrants over the coming years. Environmental disasters and migration as individual factors have complex effects on perinatal health, and environmental migrants may be at risk of specific perinatal complications. Obstetricians and maternity healthcare workers should be aware of these challenges and appreciate the individualised and specialised care that these patients require.

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.

Immunological assessment of SARS-CoV-2 infection in pregnancy from diagnosis to delivery: A multicentre prospective study.

BACKGROUND: Background Population-based data on SARS-CoV-2 infection in pregnancy and assessment of passive immunity to the neonate, is lacking. We profiled the maternal and fetal response using a combination of viral RNA from naso-pharyngeal swabs and serological assessment of antibodies against SARS-CoV-2. METHODS: This multicentre prospective observational study was conducted between March 24th and August 31st 2020. Two independent cohorts were established, a symptomatic SARS-CoV-2 cohort and a cohort of asymptomatic pregnant women attending two of the largest maternity hospitals in Europe. Symptomatic women were invited to provide a serum sample to assess antibody responses. Asymptomatic pregnant women provided a nasopharyngeal swab and serum sample. RT-PCR for viral RNA was performed using the Cobas SARS-CoV-2 6800 platform (Roche). Umbilical cord bloods were obtained at delivery. Maternal and fetal serological response was measured using both the Elecsys® Anti-SARS-CoV-2 immunoassay (Roche), Abbott SARS-CoV-2 IgG Assay and the IgM Architect assay. Informed written consent was obtained from all participants. RESULTS: Ten of twenty three symptomatic women had SARS-CoV-2 RNA detected on nasopharyngeal swabs. Five (5/23, 21.7%) demonstrated serological evidence of anti-SARS-CoV-2 IgG antibodies and seven (30.4%, 7/23) were positive for IgM antibodies. In the asymptomatic cohort, the prevalence of SARS-CoV-2 infection in RNA was 0.16% (1/608). IgG SARS-CoV-2 antibodies were detected in 1·67% (10/598, 95% CI 0·8%-3·1%) and IgM in 3·51% (21/598, 95% CI 2·3-5·5%). Nine women had repeat testing post the baseline test. Four (4/9, 44%) remained IgM positive and one remained IgG positive. 3 IgG anti-SARS-CoV-2 antibodies were detectable in cord bloods from babies born to five seropositive women who delivered during the study. The mean gestation at serological test was 34 weeks. The mean time between maternal serologic positivity and detection in umbilical cord samples was 28 days. CONCLUSION: Using two independent serological assays, we present a comprehensive illustration of the antibody response to SARS-CoV-2 in pregnancy, and show a low prevalence of asymptomatic SARS-CoV2. Transplacental migration of anti-SARS-CoV-2 antibodies was identified in cord blood of women who demonstrated antenatal anti-SARS-CoV-2 antibodies, raising the possibility of passive immunity.

Population estimates, consequences, and risk factors of obesity among pregnant and postpartum women in India: Results from a national survey and policy recommendations.

OBJECTIVE: To examine prevalence, risk factors, and consequences of maternal obesity; and provide evidence on current policies and programs to manage maternal obesity in India. METHODS: This is a mixed-methods study. We analyzed the National Family Health Survey (NFHS)-4 data (2015-16) to estimate the prevalence and risk factors of obesity, followed by a desk review of literature and stakeholder mapping with interviews to develop policy guidance. RESULTS: National prevalence of obesity (defined by WHO as body mass index ≥25) was comparable among pregnant (12%) and postpartum women (13%) ≥20 years of age. A high prevalence of obesity (>40%) was observed in over 30 districts in multiple states. Older maternal age, urban residence, increasing wealth quintile, and secondary education were associated with increased odds of obesity among pregnant and postpartum women; higher education increased odds among postpartum women only (OR 1.90; 95% CI, 1.44-2.52). Dietary variables were not associated with obesity. Several implementation challenges across healthcare system blocks were observed at policy level. CONCLUSION: Overall prevalence of obesity in India during and after pregnancy is high, with huge variation across districts. Policy and programs must be state-specific focusing on prevention, screening, and management of obesity among pregnant and postpartum women.

Clinical update on COVID-19 in pregnancy: A review article.

The data pertaining to the COVID-19 pandemic has been rapidly evolving since the first confirmed case in December 2019. This review article presents a comprehensive analysis of the current data in relation to COVID-19 and its effect on pregnant women, including symptoms, disease severity and the risk of vertical transmission. We also review the recommended management of pregnant women with suspected or confirmed COVID-19 and the various pharmacological agents that are being investigated and may have a role in the treatment of this disease. At present, it does not appear that pregnant women are at increased risk of severe infection than the general population, although there are vulnerable groups within both the pregnant and nonpregnant populations, and clinicians should be cognizant of these high-risk groups and manage them accordingly. Approximately 85% of women will experience mild disease, 10% more severe disease and 5% critical disease. The most common reported symptoms are fever, cough, shortness of breath and diarrhea. Neither vaginal delivery nor cesarean section confers additional risks, and there is minimal risk of vertical transmission to the neonate from either mode of delivery. We acknowledge that the true effect of the virus on both maternal and fetal morbidity and mortality will only be evident over time. We also discuss the impact of social isolation can have on the mental health and well-being of both patients and colleagues, and as clinicians, we must be mindful of this and offer support as necessary.

Cost-effectiveness of a mobile health-supported lifestyle intervention for pregnant women with an elevated body mass index.

OBJECTIVE: To assess the cost-effectiveness of a mobile health-supported lifestyle intervention compared with usual care. METHODS: We conducted a cost-effectiveness analysis from the perspective of the publicly-funded health care system. We estimated costs associated with the intervention and health care utilisation from first antenatal care appointment through delivery. We used bootstrap methods to quantify the uncertainty around cost-effectiveness estimates. Health outcomes assessed in this analysis were gestational weight gain (GWG; kg), incidence of excessive GWG, quality-adjusted life years (QALYs), and incidence of large-for-gestational-age (LGA). Incremental cost-effectiveness ratios (ICERs) were calculated as cost per QALY gained, cost per kg of GWG avoided, cost per case of excessive GWG averted, and cost per case of LGA averted. RESULTS: Total mean cost including intervention and health care utilisation was €3745 in the intervention group and €3471 in the control group (mean difference €274, P = 0.08). The ICER was €2914 per QALY gained. Assuming a ceiling ratio of €45,000, the probability that the intervention was cost-effective based on QALYs was 79%. Cost per kg of GWG avoided was €209. The cost-effectiveness acceptability curve (CEAC) for kg of GWG avoided reached a confidence level of 95% at €905, indicating that if one is willing to pay a maximum of an additional €905 per kg of GWG avoided, there is a 95% probability that the intervention is cost-effective. Costs per case of excessive GWG averted and case of LGA averted were €2117 and €5911, respectively. The CEAC for case of excessive GWG averted and for case of LGA averted reached a confidence level of 95% at €7090 and €25,737, respectively. CONCLUSIONS: Results suggest that a mobile-health lifestyle intervention could be cost-effective; however, a better understanding of the short- and long-term costs of LGA and excessive GWG is necessary to confirm the results.

A phenomenological exploration of change towards healthier food purchasing behaviour in women from a lower socioeconomic background using a health app.

Food purchasing is dominated by routines and habits that may hamper the use of reflective decision-making and impede change. Disrupting existing behavioural patterns may address this challenge. Individuals from a lower socioeconomic background are more likely to report unhealthier purchasing and targeted initiatives are required. Health apps offer a potential approach although little evidence is available for this specific context. This research examines the individual's experience of changing food purchasing behaviour using an app focusing on women from a lower socioeconomic background. Multiple methods across different time-points explored the individual's experience over an 8-11 week period. An accompanied shop, incorporating think-aloud and researcher observations, was undertaken at baseline, followed by an in-depth interview and questionnaire. A reflective account of the individual's experience was recorded at four weeks and grocery receipts were shared for the duration. At follow-up, an accompanied shop, in-depth interview, and questionnaire were again used. Data were analysed using interpretative phenomenological analysis. The app appeared to disrupt existing behaviour by encouraging a more conscious approach to food purchasing. Self-monitoring, problem solving, and behavioural prompts were expressed as the most effective techniques. Due to the retail environment, self-control was necessary to create and maintain healthier behaviour. Individual higher-order goals appeared to influence behaviour change and the extent to which reflective cognition was employed. The role of retailers in directing behaviour was acknowledged but it appeared that change was still viewed as individual responsibility. In conclusion, apps may facilitate healthier purchasing via specific behaviour change techniques but personal and environmental factors may influence the change process. A range of strategies may be necessary to support sufficient and sustained change.

PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol.

INTRODUCTION: Women presenting with suspected pre-eclampsia are currently triaged on the basis of hypertension and dipstick proteinuria. This may result in significant false positive and negative diagnoses resulting in increased morbidity or unnecessary intervention. Recent data suggest that placental growth factor testing may be a useful adjunct in the management of women presenting with preterm pre-eclampsia. The primary objective of this trial is to determine if the addition of placental growth factor testing to the current clinical assessment of women with suspected preterm pre-eclampsia, is beneficial for both mothers and babies. METHODS AND ANALYSIS: This is a multicentre, stepped wedge cluster, randomised trial aiming to recruit 4000 women presenting with symptoms suggestive of preterm pre-eclampsia between 20 and 36+6 weeks' gestation. The intervention of an unblinded point of care test, performed at enrolment, will quantify maternal levels of circulating plasma placental growth factor. The intervention will be rolled out sequentially, based on randomisation, in the seven largest maternity units on the island of Ireland. Primary outcome is a composite outcome of maternal morbidity (derived from the modified fullPIERS model). To ensure we are not reducing maternal morbidity at the expense of earlier delivery and worse neonatal outcomes, we have established a co-primary outcome which will examine the effect of the intervention on neonatal morbidity, assessed using a composite neonatal score. Secondary analyses will examine further clinical outcomes (such as mode of delivery, antenatal detection of growth restriction and use of antihypertensive agents) as well as a health economic analysis, of incorporation of placental growth factor testing into routine care. ETHICS AND DISSEMINATION: Ethical approval has been granted from each of the seven maternity hospitals involved in the trial. The results of the trial will be presented both nationally and internationally at conference and published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02881073.

Preeclampsia Prevention Using Routine Versus Screening Test-Indicated Aspirin in Low-Risk Women.

The objective was to evaluate whether routine aspirin 75 mg is more cost-effective than the Fetal Medicine Foundation screen-and-treat approach for preeclampsia prevention in low-risk nulliparous women. A health economic decision analytical model was devised to estimate the discounted net health and cost outcomes of routine aspirin versus Fetal Medicine Foundation screening test-indicated aspirin for a cohort of 100 000 low-risk nulliparous women. Both strategies were compared with no intervention. A subanalysis also compared disaggregated components of the algorithm. The analysis used data from hospital administration, literature, and a randomized controlled trial. Sensitivity analyses assessed the impact of aspirin adherence, test cost, and accuracy on study results. Presumed rates of preeclampsia were 3.75% with no intervention versus 0.45% with aspirin use. Results found that routine aspirin was the preferred strategy, in terms of greater health gains and larger cost savings. It provided 163 quality-adjusted life-years relative to no intervention, whereas the screen-and-treat policy achieved 108 quality-adjusted life-years. Routine aspirin would result in an estimated cost saving of €14.9 million annually relative to no intervention, whereas screen-and-treat approach would result in a smaller cost saving of €3.1 million. When the analysis was extended to consider alternative screen-and-treat strategies, routine aspirin remained the optimally cost-effective approach. In conclusion, routine aspirin use in low-risk nulliparous women has a greater health gain and cost saving compared with both the Fetal Medicine Foundation and other screen-and-treat approaches.

A feasibility study of a multidimensional breastfeeding-support intervention in Ireland.

BACKGROUND: Breastfeeding is the optimum mode of infant feeding. Despite this, most global populations do not achieve the World Health Organisation's recommendation of exclusive breast milk for the first 6 months of life. Irish breastfeeding rates are among the lowest in Europe, necessitating a well-designed breastfeeding-support intervention. AIM: To evaluate the feasibility and acceptability of a multidimensional breastfeeding intervention in a rural and an urban maternity setting in Ireland. DESIGN: A feasibility study of a breastfeeding-support intervention. SETTING: Participants were recruited from The National Maternity Hospital (Dublin, urban) and Wexford General Hospital (Wexford, rural). Questionnaires were completed antenatally, at 6 weeks postpartum and at 3 months postpartum to assess acceptability of the intervention and determine breastfeeding status. PARTICIPANTS: Pregnant women were recruited in the 3rd trimester, alongside a support partner. INTERVENTION: The intervention consisted of an antenatal class (including the physiology and practical approaches to breastfeeding), a one-to-one breastfeeding consultation with a lactation consultant after birth, access to a breastfeeding helpline, online resources, and a postnatal breastfeeding support group which included a one-to-one consultation with the lactation consultant. RESULTS: One hundred women from The National Maternity Hospital, Dublin and 27 women from Wexford General Hospital were recruited. The antenatal class was attended by 77 women in Dublin and 23 in Wexford; thus, 100 women participated in the intervention. Seventy-six women had a one-to-one postnatal consultation with a lactation consultant in Dublin and 23 in Wexford. Fifty and 45 women in Dublin, and 15 and 15 in Wexford responded to the 6-week and 3-month questionnaires, respectively. At 3 months postpartum, 70% of respondents from Dublin and 60% from Wexford were breastfeeding. Mothers perceived the one-to-one consultation with the lactation consultant during postnatal hospitalization as the most helpful part of the intervention. Inclusion of a support partner was universally viewed positively as a means to support the mother's decision to initiate and continue breastfeeding. CONCLUSION: This multidimensional intervention is well-accepted and feasible to carry out within an Irish cohort, in both urban and rural areas. Data from this feasibility study will be used to design a randomized controlled trial of a breastfeeding-support intervention.

Lower education predicts poor response to dietary intervention in pregnancy, regardless of neighbourhood affluence: secondary analysis from the ROLO randomised control trial.

OBJECTIVE: To determine if response to a low glycaemic index (GI) dietary intervention, measured by changes in dietary intake and gestational weight gain, differed across women of varying socio-economic status (SES). DESIGN: Secondary data analysis of the ROLO randomised control trial. The intervention consisted of a two-hour low-GI dietary education session in early pregnancy. Change in GI was measured using 3 d food diaries pre- and post-intervention. Gestational weight gain was categorised as per the 2009 Institute of Medicine guidelines. SES was measured using education and neighbourhood deprivation. SETTING: The National Maternity Hospital, Dublin, Ireland. SUBJECTS: Women (n 625) recruited to the ROLO randomised control trial. RESULTS: The intervention significantly reduced GI and excess gestational weight gain (EGWG) among women with third level education residing in both disadvantaged (GI, mean (sd), intervention v. control: -3·30 (5·15) v. -0·32 (4·22), P=0·024; EGWG, n (%), intervention v. control: 7 (33·6) v. 22 (67·9); P=0·022) and advantaged areas (GI: -1·13 (3·88) v. 0·06 (3·75), P=0·020; EGWG: 41 (34·1) v. 58 (52·6); P=0·006). Neither GI nor gestational weight gain differed between the intervention and control group among women with less than third level education, regardless of neighbourhood deprivation. CONCLUSIONS: A single dietary education session was not effective in reducing GI or gestational weight gain among less educated women. Multifaceted, appropriate and practical approaches are required in pregnancy interventions to improve pregnancy outcomes for less educated women.

Can promoting awareness of fetal movements and focusing interventions reduce fetal mortality? A stepped-wedge cluster randomised trial (AFFIRM).

BACKGROUND: In 2013, the stillbirth rate in the UK was 4.2 per 1000 live births, ranking 24th out of 49 high-income countries, with an annual rate of reduction of only 1.4% per year. The majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency the most common clinical finding. Maternal perception of reduced fetal movements (RFM) is associated with placental insufficiency and increased risk of subsequent stillbirth.This study will test the hypothesis that the introduction of a package of care to increase women's awareness of the need for prompt reporting of RFM and standardised management to identify fetal compromise with timely delivery in confirmed cases, will reduce the rate of stillbirth. Following the introduction of a similar intervention in Norway the odds of stillbirth fell by 30%, but the efficacy of this intervention (and possible adverse effects and implications for service delivery) has not been tested in a randomised trial. METHODS: We describe a stepped-wedge cluster trial design, in which participating hospitals in the UK and Ireland will be randomised to the timing of introduction of the care package. Outcomes (including the primary outcome of stillbirth) will be derived from detailed routinely collected maternity data, allowing us to robustly test our hypothesis. The degree of implementation of the intervention will be assessed in each site. A nested qualitative study will examine the acceptability of the intervention to women and healthcare providers and identify process issues including barriers to implementation. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Scotland A Research Ethics Committee (Ref 13/SS/0001) and from Research and Development offices in participating maternity units. The study started in February 2014 and delivery of the intervention completed in December 2016. Results of the study will be submitted for publication in peer-reviewed journals and disseminated to local investigating sites to inform education and care of women presenting with RFM. TRIAL REGISTRATION NUMBER: www.clinicaltrials.gov NCT01777022. VERSION: Protocol Version 4.2, 3 February 2017.

Behaviour change in overweight and obese pregnancy: a decision tree to support the development of antenatal lifestyle interventions.

OBJECTIVE: Antenatal healthy lifestyle interventions are frequently implemented in overweight and obese pregnancy, yet there is inconsistent reporting of the behaviour-change methods and behavioural outcomes. This limits our understanding of how and why such interventions were successful or not. DESIGN: The current paper discusses the application of behaviour-change theories and techniques within complex lifestyle interventions in overweight and obese pregnancy. The authors propose a decision tree to help guide researchers through intervention design, implementation and evaluation. The implications for adopting behaviour-change theories and techniques, and using appropriate guidance when constructing and evaluating interventions in research and clinical practice are also discussed. CONCLUSIONS: To enhance the evidence base for successful behaviour-change interventions during pregnancy, adoption of behaviour-change theories and techniques, and use of published guidelines when designing lifestyle interventions are necessary. The proposed decision tree may be a useful guide for researchers working to develop effective behaviour-change interventions in clinical settings. This guide directs researchers towards key literature sources that will be important in each stage of study development.

The East Timorese: a high-risk ethnic minority in UK obstetrics: a cohort study.

OBJECTIVE: To observe the incidence of antenatal risk-factors and adverse maternal outcome in women of East Timorese origin within a UK population. METHODS: This retrospective cohort study assessed a sample of women of East Timorese Origin (N = 42) attending UK maternity services from 01/2011 to 09/2012 compared to a control group of a standard UK maternity population (N = 7210). Data on the rate of pregnancy related risk-factors and complications were obtained from a computerized patient note database (NIMATS). RESULTS: The East Timorese were at significant risk antenatally of anaemia (OR 19.5 (95% CI 10.2-37.2) (p < 0.001)), gestational diabetes (OR 10.6 (95% CI 4.6-24.4) (p < 0.001)) and hypertension in pregnancy (OR 4.6 (95% CI 1.4-15.3) (p < 0.01)) as well as late booking for care (OR 19.5 (95% CI 10.2-37.2) p < 0.001). In terms of post-partum complications there was a significant risk of admission to the intensive-care unit (OR 20.0 (95% CI 4.5-89.0) p < 0.001) and of postpartum hemorrhage (OR 15.9 (95% CI 7.7-33.0) p < 0.001). In 72 documented occasions an interpreter could not be obtained. CONCLUSIONS: Women from East Timor are a high-risk ethnic minority who, with added risk-factors of late booking and difficulty in obtaining interpreters are at greater risk of complications in pregnancy and the puerperium.

Study protocol: differential effects of diet and physical activity based interventions in pregnancy on maternal and fetal outcomes--individual patient data (IPD) meta-analysis and health economic evaluation.

BACKGROUND: Pregnant women who gain excess weight are at risk of complications during pregnancy and in the long term. Interventions based on diet and physical activity minimise gestational weight gain with varied effect on clinical outcomes. The effect of interventions on varied groups of women based on body mass index, age, ethnicity, socioeconomic status, parity, and underlying medical conditions is not clear. Our individual patient data (IPD) meta-analysis of randomised trials will assess the differential effect of diet- and physical activity-based interventions on maternal weight gain and pregnancy outcomes in clinically relevant subgroups of women. METHODS/DESIGN: Randomised trials on diet and physical activity in pregnancy will be identified by searching the following databases: MEDLINE, EMBASE, BIOSIS, LILACS, Pascal, Science Citation Index, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and Health Technology Assessment Database. Primary researchers of the identified trials are invited to join the International Weight Management in Pregnancy Collaborative Network and share their individual patient data. We will reanalyse each study separately and confirm the findings with the original authors. Then, for each intervention type and outcome, we will perform as appropriate either a one-step or a two-step IPD meta-analysis to obtain summary estimates of effects and 95% confidence intervals, for all women combined and for each subgroup of interest. The primary outcomes are gestational weight gain and composite adverse maternal and fetal outcomes. The difference in effects between subgroups will be estimated and between-study heterogeneity suitably quantified and explored. The potential for publication bias and availability bias in the IPD obtained will be investigated. We will conduct a model-based economic evaluation to assess the cost effectiveness of the interventions to manage weight gain in pregnancy and undertake a value of information analysis to inform future research. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2013: CRD42013003804.

Public-private collaboration in clinical research during pregnancy, lactation, and childhood: joint position statement of the Early Nutrition Academy and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

This position statement summarises a view of academia regarding standards for clinical research in collaboration with commercial enterprises, focussing on trials in pregnant women, breast-feeding women, and children. It is based on a review of the available literature and an expert workshop cosponsored by the Early Nutrition Academy and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. Clinical research collaborations between academic investigators and commercial enterprises are encouraged by universities, public funding agencies, and governmental organisations. One reason is a pressing need to obtain evidence on the effects, safety, and benefits of drugs and other commercial products and services. The credibility and value of results obtained through public-private research collaborations have, however, been questioned because many examples of inappropriate research practice have become known. Clinical research in pregnant and breast-feeding women, and in infants and children, raises sensitive scientific, ethical, and societal questions and requires the application of particularly high standards. Here we provide recommendations for the conduct of public-private research collaborations in these populations. In the interest of all stakeholders, these recommendations should contribute to more reliable, credible, and acceptable results of commercially sponsored trials and to reducing the existing credibility gap.

Economics of childbirth.

BACKGROUND: Increasing birth rates have raised questions for policy makers and hospital management about the economic costs of childbirth. OBJECTIVE: The purpose of this article is to identify and review all existing scientific studies in relation to the economic costs of alternative modes of childbirth delivery and to highlight deficiencies in the existing scientific research. METHOD: We searched Cochrane, Centre for Reviews and Dissemination, EconLit, the Excerpta Medica Database, the Health Economic Evaluations Database, MEDLINE and PubMed. RESULTS: Thirty articles are included in this review. The main findings suggest that there is no internationally acceptable childbirth cost and clinical outcome classification system that allows for comparisons across different delivery modes. CONCLUSION: This review demonstrates that a better understanding and classification of the costs and associated clinical outcomes of childbirth is required to allow for valid comparisons between maternity units, and to inform policy makers and hospital management.

Imaging and assessment of placental function.

The placenta is the vital support organ for the developing fetus. This article reviews current ultrasound (US) methods of assessing placental function. The ability of ultrasound to detect placental pathology is discussed. Doppler technology to investigate the fetal, placental, and maternal circulations in both high-risk and uncomplicated pregnancies is discussed and the current literature on the value of three-dimensional power Doppler studies to assess placental volume and vascularization is also evaluated. The article highlights the need for further research into three-dimensional ultrasound and alternative methods of placental evaluation if progress is to be made in optimizing placental function assessment.