Antenatal non-medical risk assessment and care pathways to improve pregnancy outcomes: a cluster randomised controlled trial.

Social deprivation negatively affects health outcomes but receives little attention in obstetric risk selection. We investigated whether a combination of (1) risk assessment focused on non-medical risk factors, lifestyle factors, and medical risk factors, with (2) subsequent institution of risk-specific care pathways, and (3) multidisciplinary consultation between care providers from the curative and the public health sector reduced adverse pregnancy outcomes among women in selected urban areas in the Netherlands. We conducted a cluster randomised controlled trial in 14 urban municipalities across the Netherlands. Prior to the randomisation, municipalities were ranked and paired according to their expected proportion of pregnant women at risk for adverse outcomes at birth. The primary outcome was delivery of a preterm and/or small for gestational age (SGA) baby, analysed with multilevel mixed-effects logistic regression analysis adjusting for clustering and individual baseline characteristics. A total of 33 community midwife practices and nine hospitals participated throughout the study. Data from 4302 participants was included in the Intention To Treat (ITT) analysis. The intervention had no demonstrable impact on the primary outcome: adjusted odds ratio (aOR) 1.17 (95% CI 0.84-1.63). Among the secondary outcomes, the intervention improved the detection of threatening preterm delivery and fetal growth restriction during pregnancy [aOR 1.27 (95% CI 1.01-1.61)]. Implementation of additional non-medical risk assessment and preventive strategies into general practices is feasible but did not decrease the incidence of preterm and/or SGA birth in the index pregnancy in deprived urban areas.Trial registration Netherlands National Trial Register (NTR-3367).

Analysis of policy towards improvement of perinatal mortality in the Netherlands (2004-2011).

Relatively high perinatal mortality and morbidity rates(2) in the Netherlands resulted in a process which induced policy changes regarding the Dutch perinatal healthcare system. Aims of this policy analysis are (1) to identify actors, context and process factors that promoted or impeded agenda setting and formulation of policy regarding perinatal health care reform and (2) to present an overview of the renewed perinatal health policy. The policy triangle framework for policy analysis by Walt and Gilson was applied(3). Contents of policy, actors, context factors and process factors were identified by triangulation of data from three sources: a document analysis, stakeholder analysis and semi-structured interviews with key stakeholders. Analysis enabled us to chronologically reconstruct the policy process in response to the perinatal mortality rates. The quantification of the perinatal mortality problem, the openness of the debate and the nature of the topic were important process factors. Main theme of policy was that change was required in the entire spectrum of perinatal healthcare. This ranged from care in the preconception phase through to the puerperium. Furthermore emphasis was placed on the importance of preventive measures and socio-environmental determinants of health. This required involvement of the preventive setting, including municipalities. The Dutch tiered perinatal healthcare system and divergent views amongst curative perinatal health care providers were important context factors. This study provides lessons which are applicable to health care professionals and policy makers in perinatal care or other multidisciplinary fields.

Differences in perinatal morbidity and mortality on the neighbourhood level in Dutch municipalities: a population based cohort study.

BACKGROUND: In a national perinatal health programme, we observed striking heterogeneity in the explanation of the most prominent risks across municipalities. Therefore we explored the separate contribution of several socio-demographic risks on perinatal health inequalities between municipalities and neighbourhoods. The study aims to identify perinatal health inequalities on the neighbourhood level across the selected municipalities, and to objectify the contribution of socio-demographic risk factors on pregnancy outcomes in each municipality by the application of the population attributable risk concept. METHODS: Population based cohort study (2000-2008). Perinatal outcomes of 352,407 single pregnancies from 15 municipalities were analysed. Odds ratios and population attributable risks were calculated. Main outcomes were combined perinatal morbidity (small-for-gestational age, preterm birth, congenital anomalies, and low Apgar score), and perinatal mortality. RESULTS: Perinatal health inequalities existed on both the municipal and the neighbourhood level. In municipalities, combined perinatal morbidity ranged from 17.3 to 23.6%, and perinatal mortality ranges from 10.1 to 15.4‰. Considerable differences in low socio-economic status between municipalities were apparent, with prevalences ranging from 14.4 to 82.5%. In seven municipalities, significant differences between neighbourhoods existed for perinatal morbidity (adjusted OR ranging from 1.33 to 2.38) and for perinatal mortality (adjusted OR ranging from 2.06 to 5.59). For some municipalities, socio-demographic risk factors were s a strong predictor for the observed inequalities, but in other municipalities these factors were very weak predictors. If all socio-demographic determinants were set to the most favourable value in a predictive model, combined perinatal morbidity would decrease with 15 to 39% in these municipalities. CONCLUSIONS: Substantial differences in perinatal morbidity and mortality between municipalities and neighbourhoods exist. Different patterns of inequality suggest differences in etiology. Policy makers and healthcare professionals need to be informed about their local perinatal health profiles in order to introduce antenatal healthcare tailored to the individual and neighbourhood environment.

Assessment and care for non-medical risk factors in current antenatal health care.

OBJECTIVE: this study aims to identify current practice in risk assessment, current antenatal policy and referral possibilities for non-medical risk factors (lifestyle and social risk factors), and to explore the satisfaction among obstetric caregivers in their collaboration with non-obstetrical caregivers. DESIGN: cross-sectional study SETTING: Dutch antenatal care system PARTICIPANTS: community midwives from 139 midwifery practices and gynaecologists, hospital-based midwives, and trainees in obstetrics from 38 hospitals. MEASUREMENTS AND FINDINGS: results were analysed with χ(2) tests and unpaired t-tests. Caregivers universally screened upon lifestyle risk factors (e.g. smoking or drug use), whereas the screening for social risk factors (e.g. social support) was highly variable. As national guidelines are absent, local protocols were reported to be used for screening on non-medical risk factors in more than 40%. Caregivers stated multidisciplinary protocols to be a prerequisite for assessment of non-medical risk factors. Only 22% of the caregivers used predefined criteria to define when patients should be discussed multidisciplinary. CONCLUSION: despite their relevance, non-medical risk factors remain an underexposed topic in antenatal risk factor screening in both the community and hospital-based care setting. Implications for practice Structural antenatal risk assessment for non-medical risk factors with subsequent consultation opportunities is advocated, preferably based on a multidisciplinary guideline.

Effectiveness of general preconception care accompanied by a recruitment approach: protocol of a community-based cohort study (the Healthy Pregnancy 4 All study).

INTRODUCTION: Promotion of healthy pregnancies has gained high priority in the Netherlands because of the relative unfavourable perinatal outcomes. In response, a nationwide study Healthy Pregnancy 4 All (HP4ALL) has been initiated. One of the substudies within HP4ALL focuses on preconception care (PCC). PCC is an opportunity to detect and eliminate risk factors before conception to optimise health before organogenesis and placentation. The main objectives of the PCC substudy are (1) to assess the effectiveness of a recruitment strategy for the PCC health services and (2) to assess the effectiveness of individual PCC consultations. METHODS/ANALYSIS: Prospective cohort study in neighbourhoods of 14 municipalities with perinatal mortality and morbidity rates exceeding the nation's average. The theoretical framework of the PCC substudy is based on Andersen's model of healthcare utilisation (a model that evaluates the utilisation of healthcare services from a sociological perspective). Women aged 18 up to and including 41 years are targeted for utilisation of the PCC health service by a four armed recruitment strategy. The PCC health service consists of an individual PCC consultation consisting of (1) initial risk assessment and risk management and (2) a follow-up consultation to assess adherence to the management plan. The primary outcomes regarding the effectiveness of consultations is behavioural change regarding folic acid supplementation, smoking cessation, cessation of alcohol consumption and illicit substance use. The primary outcome regarding the effectiveness of the recruitment strategy is the number of women successfully recruited and the outreach in terms of which population is reached in comparison to the approached population. Data collection consists of registration in the database of women that enrol for a visit to the individual PCC consultations (women successfully recruited), and preconsultation and postconsultation measurements among the included study population (by questionnaires, anthropometric measurements and biomarkers). Sample size calculation resulted in a sample size of n=839 women. ETHICS AND DISSEMINATION: Approval for this study has been obtained from the Medical Ethical Committee of the Erasmus Medical Center of Rotterdam (MEC 2012-425). Results will be published and presented at international conferences.

An instrument for broadened risk assessment in antenatal health care including non-medical issues.

INTRODUCTION: Growing evidence on the risk contributing role of non-medical factors on pregnancy outcomes urged for a new approach in early antenatal risk selection. The evidence invites to more integration, in particular between the clinical working area and the public health domain. We developed a non-invasive, standardized instrument for comprehensive antenatal risk assessment. The current study presents the application-oriented development of a risk screening instrument for early antenatal detection of risk factors and tailored prevention in an integrated care setting. METHODS: A review of published instruments complemented with evidence from cohort studies. Selection and standardization of risk factors associated with small for gestational age, preterm birth, congenital anomalies and perinatal mortality. Risk factors were weighted to obtain a cumulative risk score. Responses were then connected to corresponding care pathways. A cumulative risk threshold was defined, which can be adapted to the population and the availability of preventive facilities. A score above the threshold implies multidisciplinary consultation between caregivers. RESULTS: The resulting digital score card consisted of 70 items, subdivided into four non-medical and two medical domains. Weighing of risk factors was based on existing evidence. Pilot-evidence from a cohort of 218 pregnancies in a multi-practice urban setting showed a cut-off of 16 points would imply 20% of all pregnant women to be assessed in a multidisciplinary setting. A total of 28 care pathways were defined. CONCLUSION: The resulting score card is a universal risk screening instrument which incorporates recent evidence on non-medical risk factors for adverse pregnancy outcomes and enables systematic risk management in an integrated antenatal health care setting.

Effectiveness of score card-based antenatal risk selection, care pathways, and multidisciplinary consultation in the Healthy Pregnancy 4 All study (HP4ALL): study protocol for a cluster randomized controlled trial.

BACKGROUND: Promotion of healthy pregnancies has gained high priority in the Netherlands because of relatively unfavorable perinatal outcomes. In response, a nationwide study, 'Healthy Pregnancy 4 All' (HP4ALL), has been initiated. Part of this study involves systematic and broadened antenatal risk assessment (the Risk Assessment substudy). Risk selection in current clinical practice is mainly based on medical risk factors. Despite the increasing evidence for the influence of nonmedical risk factors (social status, lifestyle or ethnicity) on perinatal outcomes, these risk factors remain highly unexposed. Systematic risk selection, combined with customized care pathways to reduce or treat detected risks, and regular and structured consultation between community midwives, gynecologists and other care providers such as social workers, is part of this study. METHODS/DESIGN: Neighborhoods in 14 municipalities with adverse perinatal outcomes above national and municipal averages are selected for participation. The study concerns a cluster randomized controlled trial. Municipalities are randomly allocated to intervention (n = 3,500 pregnant women) and control groups (n = 3,500 pregnant women). The intervention consists of systematic risk selection with the Rotterdam Reproductive Risk Reduction (R4U) score card in pregnant women at the booking visit, and referral to corresponding care pathways. A risk score, based on weighed risk factors derived from the R4U, above a predefined threshold determines structured multidisciplinary consultation. Primary outcomes of this trial are dysmaturity (birth weight < p10), prematurity (birth <37 weeks), and efficacy of implementation. DISCUSSION: The 'HP4ALL' study introduces a systematic approach in antenatal health care that may improve perinatal outcomes and, thereby, affect future health status of a new generation in the Netherlands. TRIAL REGISTRATION: Dutch Trial Registry ( NTR-3367) on 20 March 2012.

Design and outline of the Healthy Pregnancy 4 All study.

BACKGROUND: Promotion of healthy pregnancies has gained high priority in the Netherlands because of the relatively unfavourable perinatal health outcomes. In response a nationwide study Healthy Pregnancy 4 All was initiated. This study combines public health and epidemiologic research to evaluate the effectiveness of two obstetric interventions before and during pregnancy: (1) programmatic preconception care (PCC) and (2) systematic antenatal risk assessment (including both medical and non-medical risk factors) followed by patient-tailored multidisciplinary care pathways. In this paper we present an overview of the study setting and outlines. We describe the selection of geographical areas and introduce the design and outline of the preconception care and the antenatal risk assessment studies. METHODS/DESIGN: A thorough analysis was performed to identify geographical areas in which adverse perinatal outcomes were high. These areas were regarded as eligible for either or both sub-studies as we hypothesised studies to have maximal effect there. This selection of municipalities was based on multiple criteria relevant to either the preconception care intervention or the antenatal risk assessment intervention, or to both. The preconception care intervention was designed as a prospective community-based cohort study. The antenatal risk assessment intervention was designed as a cluster randomised controlled trial - where municipalities are randomly allocated to intervention and control. DISCUSSION: Optimal linkage is sought between curative and preventive care, public health, government, and social welfare organisations. To our knowledge, this is the first study in which these elements are combined.

[Foetal and neonatal mortality in a European perspective: improvement of perinatal health care in the Netherlands still necessary]. / Foetale en neonatale sterfte in Europees perspectief: verbetering van de verloskundige zorg in Nederland blijft nodig.

Results from the Euro-Peristat project in 2000 and 2004 showed the Netherlands to have higher perinatal mortality rates and a slower rate of decline than in other European countries. Recent results from the 2010 Euro-Peristat project have shown a substantial decline in both foetal and neonatal mortality rates and an improved position in the European ranking. However, the comparison of the Netherlands to countries with similar population characteristics and healthcare systems puts this position in a different perspective. Continuing effort will be necessary to improve perinatal health and care in the Netherlands.

Deprived neighborhoods and adverse perinatal outcome: a systematic review and meta-analysis.

OBJECTIVES: This study aims to summarize evidence on the relation between neighborhood deprivation and the risks for preterm birth, small-for-gestational age, and stillbirth. DESIGN: The design was a systematic review and meta-analysis. MAIN OUTCOME MEASURES: The main outcome measures included studies that directly compared the risk of living in the most deprived neighborhood quintile with least deprived quintile for at least one perinatal outcome of interest (preterm delivery, small-for-gestational age and stillbirth). METHODS: Study selection was based on a search of Medline, Embase and Web of Science for articles published up to April 2012, reference list screening, and email contact with authors. Data on study characteristics, outcome measures, and quality were extracted by two independent investigators. Random-effects meta-analysis was performed to estimate unadjusted and adjusted summary odds ratios with the associated 95% confidence intervals. RESULTS: We identified 2863 articles, of which 24 were included in a systematic review. A meta-analysis (n = 7 studies, including 2 579 032 pregnancies) assessed the risk of adverse perinatal outcomes by comparing the most deprived neighborhood quintile with the least deprived quintile. Compared with the least deprived quintile, odds ratios for adverse perinatal outcomes in the most deprived neighborhood quintile were significantly increased for preterm delivery (odds ratio 1.23, 95% confidence interval 1.18-1.28), small-for-gestational age (odds ratio 1.31, 95% confidence interval 1.28-1.34), and stillbirth (odds ratio 1.33, 95% confidence interval 1.21-1.45). CONCLUSIONS: Living in a deprived neighborhood is associated with preterm birth, small-for-gestational age and stillbirth.

The current state of active third stage management to prevent postpartum hemorrhage: a cross-sectional study.

OBJECTIVE: To investigate the implementation of the International Confederation of Midwives/International Federation of Gynecology and Obstetrics (ICM/FIGO) guideline on active third stage management in vaginal deliveries in daily clinical practice. DESIGN: Observational, cross-sectional study. SETTING: One tertiary and one teaching hospital in the Netherlands. POPULATION: Women undergoing vaginal deliveries. METHODS: A case record form was completed after every vaginal delivery. Primary outcome was adequate guideline adherence, defined as initial administration of 10 IU oxytocin, performance of controlled cord traction and uterine massage. Adequate guideline adherence was a priori estimated to be 10%. With a sample size of 600, i.e. 300 women per hospital, the standard error of the resulting percentage would be less than 2% for each hospital. RESULTS: Six hundred and twenty six women were included. Guideline adherence was adequately performed in 48% of vaginal deliveries. Oxytocin was administered after birth in 98% of deliveries and in 80% the correct dose was used. Controlled cord traction was performed in 63% and uterine massage in 93%; however, the latter was performed as advised (at least eight times) in only 8%. The amount of blood loss was not associated with the use of either 5 or 10 IU oxytocin (p = 0.818). Controlled cord traction and uterine massage were more frequently performed when blood loss exceeded 500 mL (p < 0.001). CONCLUSIONS: Active third stage management according to the ICM/FIGO guideline is adequately performed in only 48% of all vaginal deliveries. Results of this study call for training programs to increase adherence to the ICM/FIGO guideline.

Congenital adrenal hyperplasia: do the benefits of prenatal treatment defeat the risks?

UNLABELLED: Congenital adrenal hyperplasia (CAH) is caused by a defect in any of the 5 enzymes necessary for the synthesis of cortisol. However, in more than 90% of cases, CAH results from a defect in the enzyme 21-hydroxylase. Antenatal dexamethasone for the treatment of fetuses with CAH was introduced in 1978, and has been shown to prevent virilizaton of affected girls. Some researchers have been concerned about the possible long-term side effects of this therapy. A variety of studies have evaluated cognition and behavioral traits as well as metabolic alterations in treated children and in animals, and some investigators have reported adverse effects of antenatal treatment, but no firm conclusions about the potential risks of dexamethasone have been reached. This review summarizes the outcomes of affected children with and without antenatal dexamethasone treatment, and evaluates the benefits of prenatal treatment as well as the potential risks. TARGET AUDIENCE: Obstetricians & Gynecologists, Family Physicians. LEARNING OBJECTIVES: After completion of this article, the reader should be able to recall the pathophysiology, broad clinical presentation, differences in prognosis with and without antenatal treatment, and face the importance of the antenatal dexamethasone treatment in congenital adrenal hyperplasia despite the potential adverse effects.