Piloting a complex intervention to promote a tobacco and alcohol-free pregnancy: the Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy study.

BACKGROUND: Tobacco smoking and alcohol consumption before and during pregnancy increase the risk of adverse health outcomes for mother and child. Interventions to address smoking and drinking before and during pregnancy have the potential to reduce early-life health inequalities. In the Smoke and Alcohol Free with EHealth and Rewards (SAFER) pilot study we aimed to evaluate the acceptability, feasibility and effectiveness of a complex intervention supporting women in smoking and alcohol cessation before and during pregnancy. METHODS: From February 2019 till March 2021, we piloted the SAFER pregnancy intervention among pregnant women and women planning pregnancy in South-West Netherlands in an uncontrolled before-after study. Participants were supported in smoking and alcohol cessation via up to six group sessions and an online platform. In addition, biochemically validated cessation was rewarded with incentives (i.e. shopping vouchers) amounting up to 185 euros. We aimed to include 66 women. The primary outcome was smoking and/or alcohol cessation at 34-38 weeks of gestation (if pregnant) or after six group sessions (if not pregnant). Quantitative data were analysed using descriptive statistics. Focus group interviews among those involved in the study were conducted at the end of the study to explore their experiences. Qualitative data was analysed using thematic analysis. RESULTS: Thirty-nine women who smoked were included; no women who consumed alcohol were referred to the study. Unemployment (51%), financial problems (36%) and a smoking partner (72%) were common. Thirteen women (33%) dropped out, often due to other problems impeding smoking cessation or 'being too busy' to participate in the group sessions. Eleven women (28%) had quit smoking at the study's endpoint. The personal and positive approach was highly valued and biochemical validation was felt to be helpful. CONCLUSION: The SAFER pregnancy intervention seems appropriate for women in need of extra support for smoking cessation before and during pregnancy. Its impact on alcohol cessation could not be studied due to recruitment issues. Recruitment and prevention of early dropout need attention in further development of this intervention. TRIAL REGISTRATION: Netherlands Trial Register: NL7493. Date registered: 04/02/2019.

Incentives for Smoking Cessation During Pregnancy: An Ethical Framework.

INTRODUCTION: Smoking during pregnancy increases the risk of morbidity and mortality of the mother and child. The inability of the unborn child to protect itself, raises the social and academic responsibility to protect the child from the harmful effects of smoking. Interventions including rewards (incentives) for lifestyle changes are an upcoming trend and can encourage women to quit smoking. However, these incentives can, as we will argue, also have negative consequences, for example the restriction of personal autonomy and encouragement of smoking to become eligible for participation. To prevent these negative consequences, we developed an ethical framework that enables to assess and address unwanted consequences of incentive-based interventions whereby moral permissibility can be evaluated. AIMS AND METHODS: The possible adverse consequences of incentives were identified through an extensive literature search. Subsequently, we developed ethical criteria to identify these consequences based on the biomedical ethical principles of Beauchamp and Childress. RESULTS: Our framework consists of 12 criteria. These criteria concern (1) effectiveness, (2) support of a healthy lifestyle, (3) motivational for the target population, (4) stimulating unhealthy behavior, (5) negative attitudes, (6) personal autonomy, (7) intrinsic motivation, (8) privacy, (9) fairness, (10) allocation of incentives, (11) cost-effectiveness, and (12) health inequity. Based on these criteria, the moral permissibility of potential interventions can be evaluated. CONCLUSIONS: Incentives for smoking cessation are a response to the responsibility to protect the unborn child. But these interventions might have possible adverse effects. This ethical framework aims to identify and address ethical pitfalls in order to avoid these adverse effects. IMPLICATIONS: Although various interventions to promote smoking cessation during pregnancy exist, many women still smoke during pregnancy. Interventions using incentives for smoking cessation during pregnancy are a promising and upcoming trend but can have unwanted consequences. This ethical framework helps to identify and address ethical pitfalls in order to avoid these adverse effects.It can be a practical tool in the development and evaluation of these interventions and in evaluating the moral permissibility of interventions using incentives for smoking cessation during pregnancy.

The effect of a preconception care outreach strategy: the Healthy Pregnancy 4 All study.

BACKGROUND: Preconception care has been acknowledged as an intervention to reduce perinatal mortality and morbidity. However, utilization of preconception care is low because of low awareness of availability and benefits of the service. An outreach strategy was employed to promote uptake of preconception care consultations. Its effect on the uptake of preconception care consultations was evaluated within the Healthy Pregnancy 4 All study. METHODS: We conducted a community-based intervention study. The outreach strategy for preconception care consultations included four approaches: (1) letters from municipal health services; (2) letters from general practitioners; (3) information leaflets by preventive child healthcare services and (4) encouragement by peer health educators. The target population was set as women aged 18 to 41 years in 14 Dutch municipalities with relatively high perinatal morbidity and mortality rates. We evaluated the effect of the outreach strategy by analyzing uptake of preconception care consultations between February 2013 and December 2014. Registration data of applications for preconception care as well as participant questionnaires were obtained for analysis. RESULTS: The outreach strategy led to 587 applications for preconception care consultations. The majority of applications (n = 424; 72%) were prompted by the invitation letters (132,129) from the municipalities and general practitioners. The effect of the municipal letter seemed to fade out after 3 months. CONCLUSIONS: Outreach strategies amongst the general population promote uptake of preconception care consultations, although on a small scale and with a temporary effect.

Developing social marketed individual preconception care consultations: Which consumer preferences should it meet?

AIMS: Preconception care (PCC) is care that aims to improve the health of offspring by addressing risk factors in the pre-pregnancy period. Consultations are recognized as a method to promote perinatal health. However, prospective parents underutilize PCC services. Uptake can improve if delivery approaches satisfy consumer preferences. Aim of this study was to identify preferences of women (consumers) as a first step to social marketed individual PCC consultations. METHODS: In depth, semi-structured interviews were performed to identify women's views regarding the four components of the social marketing model: product (individual PCC consultation), place (setting), promotion (how women are made aware of the product) and price (costs). Participants were recruited from general practices and a midwife's practice. Content analysis was performed by systematic coding with NVIVO software. RESULTS: The 39 participants reflected a multiethnic intermediately educated population. Product: Many participants had little knowledge of the need and the benefits of the product. Regarding the content of PCC, they wish to address fertility concerns and social aspects of parenthood. PCC was seen as an informing and coaching service with a predominant role for health-care professionals. PLACE: the general practitioner and midwife setting was the most mentioned setting. Promotion: A professional led promotion approach was preferred. Price: Introduction of a fee for PCC consultations will make people reconsider their need for a consultation and could exclude vulnerable patients from utilization. CONCLUSION: This study provides consumer orientated data to design a social marketed delivery approach for individual PCC consultations.

Current practice of preconception care by primary caregivers in the Netherlands.

OBJECTIVES: Over the past decade the value of preconception care (PCC) consultations has been acknowledged. Investments have been made to promote delivery and uptake of PCC consultations in the Dutch primary care setting. We assessed current activities, perceptions and prerequisites for delivery of PCC in primary care. METHODS: A questionnaire was compiled and distributed by mail or e-mail among 1682 general practitioners (GPs) and 746 midwives in the Netherlands between 2013 and 2014. RESULTS: The questionnaire was completed by 449 GPs and 250 midwives. While GPs and midwives were frequently asked about preconception risks, explicit requests by patients for a PCC consultation were less frequent. Although caregivers gave information on preconception risk factors, only a minority recommended PCC in the form of a dedicated consultation. Such consultations occurred infrequently. Risk factor assessment varied between GPs and midwives. Respondents' perceptions of PCC consultations, however, were generally positive. A small proportion believed that PCC medicalised pregnancy, and recognised barriers in actively raising the topic of patients' pregnancy wishes. More training, staff, promotion of PCC and adequate reimbursement were prerequisites for future delivery. GPs differed in their opinion of whether they or midwives were primarily responsible for PCC consultations. Midwives, however, saw themselves as responsible for providing PCC consultations. CONCLUSIONS: Primary care is underserving prospective parents with regards to PCC consultations. Targets to increase delivery of systematic PCC are: (1) promotion during routine care; (2) increased use of tools; (3) increased collaboration among primary caregivers; (4) reduction of caregivers' negative perceptions; and (5) tailoring PCC consultations to suit women's preferences.

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.

[Best possible start for child and parent]. / Kansrijke start voor kind en ouder.

The health of women during the periconception period and pregnancy is important for a healthy start of the child. All care providers can make a major contribution to this. In this learning article we provide answers to a number of questions that have been collected from the professional field about preconception care and care for vulnerable pregnant women. Our aim is to inform general practitioners and specialists who assist women with a (possible) desire to have children about proactive care in pregnancy, childbirth and child care. Included are concrete actions of the general practitioner when healthy women wish to become pregnant, which medical history and other characteristics of a pregnant woman negatively affects the health of her (unborn) child, and which signals in a first pregnancy predispose for problems after and in a subsequent pregnancy and what role can the GP play in this. Furthermore, we discuss signs of vulnerability in the consulting room, how transmural risk selection can be applied and we provide an overview of interventions applicable in primary care or where to refer to.

Change in Lifestyle Behaviors After Preconception Care: A Prospective Cohort Study.

PURPOSE: To evaluate the effects of preconception care (PCC) consultations by change in lifestyle behaviors. SETTING AND INTERVENTION: Women in deprived neighborhoods of 14 Dutch municipalities were encouraged to visit a general practitioner or midwife for PCC. SAMPLE: The study included women aged 18 to 41 years who had a PCC consultation. DESIGN: In this community-based prospective cohort study, we assessed initiation of folic acid supplementation, cessation of smoking, alcohol consumption, and illicit drug use. MEASURES: Self-reported and biomarker data on behavioral changes were obtained at baseline and 3 months later. ANALYSIS: The changes in prevalence were assessed with the McNemar test. RESULTS: Of the 259 included participants, paired analyses were available in 177 participants for self-reported outcomes and in 82 for biomarker outcomes. Baseline self-reported prevalence of no folic acid use was 36%, smoking 12%, weekly alcohol use 22%, and binge drinking 17%. Significant changes in prevalence toward better lifestyle during follow-up were seen for folic acid use (both self-reported, P < .001; and biomarker-confirmed, P = .008) and for self-reported binge drinking (P = .007). CONCLUSION: Our study suggests that PCC contributes to initiation of folic acid supplementation and cessation of binge drinking in women who intend to become pregnant. Although based on a small sample, the study adds to the limited body of evidence regarding the benefits of PCC in improving periconception health.

Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy study: a before-after study protocol.

Despite existing interventions, tobacco smoking and alcohol consumption during pregnancy are common. The Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy intervention combines monthly group sessions, access to a web-based platform and incentives upon biochemically validated cessation for a maximum duration of 6 months to promote cessation of smoking and alcohol use before and during pregnancy. To inform development of the SAFER pregnancy intervention, two focus groups with the target population were held beforehand, with results reported here alongside the final SAFER pregnancy study protocol. In a before-after study we aim to include 66 women who are pregnant or have a wish to become pregnant and who smoke and/or consume alcohol (i.e. target population of the SAFER pregnancy intervention). The primary outcome measure is cessation of smoking and/or alcohol use at 34-38 weeks of gestation, or after six group sessions if women did not become pregnant during the study period. Secondary outcomes focus on the barriers and facilitators for implementation of the SAFER pregnancy intervention.

Pre-conception counselling in primary care: prevalence of risk factors among couples contemplating pregnancy.

The outcome of pregnancy can be influenced by several risk factors. Women who are informed about these risks during pre-conception counselling (PCC) have an opportunity to take preventive measures in time. Several studies have shown that high-risk populations have a high prevalence of such risk factors. However, prevalence in the general population, which is assumed to be low risk, is largely unknown. We therefore provided a systematic programme of PCC for the general population and studied the prevalence of risk factors using the risk-assessment questionnaire which was part of the PCC. None of the couples reported no risk factors at all and only 2% of the couples reported risk factors for which written information was considered to be sufficient. Therefore, 98% of all couples reported one or more risk factors for which at least personal counselling by a general practitioner (GP) was indicated. Many of these factors were related to an unhealthy lifestyle. Women with a low level of education reported more risk factors than women with a high level of education. There is a great need for PCC as shown by the fact that almost all couples reported risk factors for which personal counselling was indicated. Pre-conception counselling may reduce the risk of adverse pregnancy outcome by enabling couples to avoid these risks. PCC can be provided by GPs, who have the necessary medical knowledge and background information to counsel couples who wish to have a baby.

The effect of preconception counselling on lifestyle and other behaviour before and during pregnancy.

BACKGROUND: Recent studies suggest that the basis for adverse pregnancy outcomes is often established early in pregnancy, during organogenesis. It is therefore important to take preventive action as early as possible, preferably before pregnancy. Because most adverse pregnancy outcomes occur in women who are unaware of being at risk, we conducted a randomized controlled trial, "Parents to Be." With this study, we sought to assess the extent to which women who have participated in preconception counseling (PCC) increase their knowledge on pregnancy-related risk factors and preventive measures and change their behavior before and during pregnancy and to provide an overview of adverse pregnancy outcomes among such women. METHODS: Knowledge: Women aged 18-40 who attended PCC and women who received standard care were matched on previous pregnancy, time since last pregnancy, age, country of birth, and educational achievement. They were sent a questionnaire on knowledge about pregnancy-related risk factors and preventive measures. Behavior: Data on pregnancies and outcomes were collected. Two months after pregnancy, a questionnaire was sent regarding behavior before and during pregnancy. RESULTS: Knowledge of women who received PCC (81.5%; n=211) exceeded that of women who did not (76.9%; n=422). Levels of knowledge in women who were not yet pregnant after PCC were comparable to those in women who became pregnant after PCC, indicating that, even before pregnancy, PCC increased knowledge in women contemplating pregnancy. After PCC, significantly more women started using folic acid before pregnancy (adjusted odds ratio [OR], 4.93; 95% confidence interval [CI], 2.81-8.66) and reduced alcohol use during the first 3 months of pregnancy (adjusted OR, 1.79; 95% CI, 1.08-2.97). Among the group receiving standard care, about 20% of all pregnancies ended in an adverse outcome; in the group with PCC this was 16% (OR, 0.77; 95% CI, 0.48-1.22). CONCLUSION: After PCC, women have more knowledge about essential items. Importantly, they gained this greater knowledge before pregnancy and more women changed their behavior to reduce adverse pregnancy outcomes.

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.

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.

[Summary of the NHG Standard 'Preconception care']. / Samenvatting van de NHG-Standaard 'Preconceptiezorg'.

Preconception care is part is the primary care by general practitioners and midwives in the Netherlands. The Dutch College of General Practitioners' (NHG) practice guideline 'Preconception care' gives the general practitioner guidelines for assisting couples to be well informed and in the best possible health before conception. The guideline advises general practitioners to be alert for prescription of chronic medication to women wishing to have a child and informs couples wishing to have a child of the availability of a preconception consultation. The general practitioner should review which interventions are necessary in women with chronic disorders. A thorough medical family history is required for the man as well as the woman. Their employment situation and conditions also need to be reviewed. In the case of desire for a child, folic acid is advised. In addition, the practitioner should give advice concerning stopping smoking, healthy weight and avoidance of alcohol use during pregnancy. Implementation of the guideline is especially important for the less educated and for immigrants, as these groups have less healthy lifestyle habits and less knowledge of risk factors in pregnancy.