A comparison of infants' birth defects self-reported by mothers with data provided by general practitioners: Data from the Dutch Pregnancy Drug Register.

BACKGROUND: Since the presence of a birth defect is often a primary outcome in drug-safety studies among pregnant women, researching the validity of data collection methods is imperative. The aim of this study is to compare self-reported birth defects in infants by mothers with the information provided by general practitioners (GP (singular) or GPs (plural)). METHODS: Mothers who participated in the Dutch Pregnancy Drug Register reported information about possible birth defects of their infants via questionnaires. GPs were approached to provide information on possible birth defects of the same infants. All reported birth defects by mothers and GPs were blindly coded using the International Classification of Diseases, Tenth Revision (ICD-10) index and EUROCAT-classified as either a minor or major birth defect. Differences in reported birth defects between participants and GPs were assessed. RESULTS: Participants and GPs (N = 551) reported 67 and 53 birth defects respectively, leading to a total of 120 birth defects among 65 infants. When both the GP and the participant reported a birth defect, 76.9% of these birth defects (N = 60) were coded with an identical ICD-10 code. Information on the absence of a birth defect and the presence of a major birth defect was identically reported by the GP and the mother in almost all cases (98.2%). Of the major birth defects reported by the GP, 67% could be matched with information provided by the participant, for 33% contradicting information was reported. CONCLUSION: Self-reported questionnaire data on infants' birth defects from mothers yield fairly similar information compared to information obtained through GPs. Future studies should validate the accuracy of self-reported birth defects by mothers more extensively to improve the quality of drug safety studies during pregnancy.

Knowledge and skills used for clinical decision-making on childbirth interventions: A qualitative study among midwives in the Netherlands.

INTRODUCTION: Appropriate use of interventions in maternity care is a worldwide issue. Midwifery-led models of care are associated with more efficient use of resources, fewer medical interventions, and improved outcomes. However, the use of interventions varies considerably between midwives. The aim of this study was to explore how knowledge and skills influence clinical decision-making of midwives on the appropriate use of childbirth interventions. METHODS: A qualitative study using in-depth interviews with 20 primary care midwives was performed in June 2019. Participants' clinical experience varied in the use of interventions. The interviews combined a narrative approach with a semi-structured question route. Data were analyzed using deductive content analysis. RESULTS: 'Knowledge', 'Critical thinking skills', and 'Communication skills' influenced midwives' clinical decision-making towards childbirth interventions. Midwives obtained their knowledge through the formal education program and extended their knowledge by reflecting on experiences and evidence. Midwives with a low use of interventions seem to have a higher level of reflective skills, including reflection-in-action. These midwives used a more balanced communication style with instrumental and affective communication skills in interaction with women, and have more skills to engage in discussions during collaboration with other professionals, and thus personalizing their care. CONCLUSIONS: Midwives with a low use of interventions seemed to have the knowledge and skills of a reflective practitioner, leading to more personalized care compared to standardized care as defined in protocols. Learning through reflectivity, critical thinking skills, and instrumental and affective communication skills, need to be stimulated and trained to pursue appropriate, personalized use of interventions.

Experiences, Beliefs, and Values Influencing Midwives' Attitudes Toward the Use of Childbirth Interventions.

INTRODUCTION: Intervention rates in perinatal care vary between and within countries, without populations' characteristics as a full explanation. Research suggests that one factor in this variation might be the attitudes of perinatal health care providers. Systematic knowledge on the background of midwives' attitudes and how this influences the use of interventions is limited. The study aim was to to explore experiences, beliefs, and values that influence midwives' attitudes toward interventions in perinatal care. METHODS: A qualitative study using in-depth interviews with primary care midwives (n = 20) in the Netherlands. The interviews were performed in June 2019 and combined a narrative approach with a semistructured interview guide. Inductive content analysis was applied. RESULTS: We identified 2 main themes: attitudes toward interventions and influences on midwives' attitudes. The midwives in our study described their attitudes toward interventions as oriented to either wait and see or check and control. Care based on wait and see displayed a more supportive style of behavior, and care based on check and control appeared to display a more directive style of behavior. In the theme of influences on midwives' attitudes, 3 subthemes emerged: experiences in collaboration, trust and fear, and woman-centeredness. DISCUSSION: Midwives with a wait and see attitude seem to have a more restricted approach toward interventions compared with midwives with a check and control attitude. Midwives need to be aware how their experiences, beliefs, and values shape their attitudes toward use of interventions. This awareness could be a first step toward the reduction of unwarranted interventions.

Planning is not equivalent to preparing, how Dutch women perceive their pregnancy planning in relation to preconceptional lifestyle behaviour change - a cross-sectional study.

BACKGROUND: Unhealthy prenatal lifestyle behaviours are associated with adverse pregnancy outcomes, but little is known about what motivates women to comply with preconceptional lifestyle recommendations or consciously plan their pregnancy. Therefore, the objective of this study is to explore the associations between preconceptional lifestyle behaviours, health beliefs and pregnancy planning among Dutch pregnant women. METHODS: In this cross-sectional study based on the data of the APROPOS-II study, 1,077 low-risk pregnant women were eligible for inclusion. Preconception lifestyle behaviours and actively preparing for pregnancy were assessed in relation to planned pregnancies (based on the London Measure of Unplanned Pregnancies) and health beliefs (14 statements). The following preconceptional lifestyle behaviours were assessed through a self-administered questionnaire in the first trimester of pregnancy: fruit intake, vegetable intake, caffeine intake, (second-hand)smoking, alcohol intake, folic acid supplement use and exercise. Data were analysed using multivariate logistic regression analyses. RESULTS: A total of 921 (85.5%) women in our cohort had a planned pregnancy. However, of these women, 640 (69.5%) adequately used folic acid supplements and 465 (50.5%) women consumed alcohol at any point during pregnancy. Of the women considering themselves 'healthy enough and not needing preconception care', 48 (9.1%) women had an adequate vegetable intake, 294 (55.6%) women consumed alcohol at any point during pregnancy and 161 (30.4%) women were either over-or underweight. CONCLUSION: Despite consciously planning their pregnancy, most women did not adhere to preconceptional lifestyle behaviour recommendations. Women's health beliefs and overestimation of their health status seem to interfere with actively planning and preparing for pregnancy. Findings from our study may encourage the development of prospective health-promoting interventions that focus on health beliefs and actively preparing for pregnancy, to improve preconceptional lifestyle behaviours, thereby optimizing the health of future generations.

Exploring male perceptions regarding the need to engage in preconception care - a mixed-method study amongst Dutch (prospective) fathers.

PURPOSE: While most preconception care (PCC) interventions are aimed at women, men are also in need of PCC to reduce risk factors affecting the spermatozoa quality. The objective of this study is to explore male perceptions regarding the need to engage in PCC. MATERIALS AND METHODS: In a mixed-method cross-sectional study, 229 men participated with a questionnaire and 14 individual semi-structured interviews were conducted. Questionnaires data were analysed using multiple regression analyses. The interviews were analysed using thematic analyses. RESULTS: Most men did not retrieve preconceptional information (n = 135; 59.0%) nor visited a preconceptional consult (n = 182; 79.5%). Men who categorised their preconceptional lifestyle as unhealthy (score ≤6 out of 10) less often retrieved information (adjusted OR 0.36 [95% CI 0.14-0.93]) than men with a healthy preconceptional lifestyle. While several men expressed their fear for infertility, this did not lead to an increased uptake of PCC as men felt they were healthy enough already. CONCLUSION: Despite high awareness of the positive influence of a healthy lifestyle, the perceived need for preparing for pregnancy among men remains low. Tailoring preconceptional information towards male needs provides a window of opportunity to improve men's reproductive health and possibly the health of future generations.

How to improve preconception care in a local setting? Views from Dutch multidisciplinary healthcare providers.

OBJECTIVE: To explore healthcare providers' views on improving preconception care in their region. DESIGN: Mixed-methods study. SETTING: Working conferences aimed to educate healthcare providers on preconceptional risk factors and conduct a region-specific analysis of barriers and facilitators for implementing preconception care, were organised in ten municipalities in the Netherlands. PARTICIPANTS: 250 healthcare providers of various disciplines attended a working conference and participated in the study. MEASUREMENTS AND FINDINGS: Participants were asked to both fill out a questionnaire concerning statements and experiences with preconception care and to participate in a workshop, to identify barriers and facilitators for the implementation of a local preconception care program. Almost all healthcare providers suggested that the responsibility for providing preconception care consultations lies within primary care (general practitioners (n = 239; 95.6%) and midwives (n = 236; 94.4%)). Professionals other than midwives found it significantly more difficult to start a conversation about a wish to conceive compared to midwives (26.8% versus 20.2%, p-value = 0.006) and felt less competent to provide preconceptional information (32.3% versus 15.1%, p-value = <0.001). Innovative facilitators were mentioned to improve reaching the target population with preconceptional information, i.e. the use of social media and local ambassadors. KEY CONCLUSION: While the responsibility for providing preconception care consultations is best suited with primary care, many other healthcare providers involved may act as referrers towards preconception care. Still, approximately 1 in 7 midwives (strongly) disagree with the statement that it is part of their job to provide preconceptional information to couples with a wish to conceive. IMPLICATIONS FOR PRACTICE: There is a need for integrating preconception care in many curricula and postgraduate courses, especially for non-midwives, to improve the delivery of preconception care. Insights in the suggested barriers and facilitators can improve the implementation of (local) preconception care programs.

Associations between periconceptional lifestyle behaviours and adverse pregnancy outcomes.

BACKGROUND: While the potential adverse outcomes of prenatal exposure to unhealthy lifestyle are widely evidenced, little is known about these exposures in the periconception period. We investigated the associations between lifestyle behaviours and adverse pregnancy outcomes with a unique distinction between preconceptional- and prenatal lifestyle behaviours. METHODS: A secondary analysis took place within a prospective multicentre cohort study in the Netherlands, including 3,684 pregnant women. Baseline characteristics and preconceptional and first trimester lifestyle behaviours were assessed through a self-administered questionnaire in the first trimester. Adverse pregnancy outcomes (hypertensive disorders in pregnancy (HDP), small for gestational age (SGA), gestational diabetes (GDM) and spontaneous preterm birth (sPTB)) were reported by healthcare professionals. Data were collected between 2012 and 2014 and analysed using multivariate logistic regression. RESULTS: Women who are overweight, and especially obese, have the highest odds of developing any adverse pregnancy outcome (adjusted odds ratio (aOR) 1.61 (95 % Confidence Interval (CI) 1.31-1.99) and aOR 2.85 (95 %CI 2.20-3.68), respectively), particularly HDP and GDM. Women who prenatally continued smoking attained higher odds for SGA (aOR 1.91 (95 %CI 1.05-1.15)) compared to the reference group, but these odds decreased when women prenatally quit smoking (aOR 1.14 (95 %CI 0.59-2.21)). Women who did not use folic acid supplements tended to have a higher odds of developing adverse pregnancy outcomes (aOR 1.28 (95 %CI 0.97-1.69)), while women who prenatally started folic acid supplements did not (aOR 1.01 (95 %CI 0.82-1.25)). CONCLUSIONS: Our results indicate that smoking cessation, having a normal body mass index (BMI) and initiating folic acid supplements preconceptionally may decrease the risk of adverse pregnancy outcomes. Therefore, intervening as early as the preconception period could benefit the health of future generations.

Study design of a stepped wedge cluster randomized controlled trial to evaluate the effect of a locally tailored approach for preconception care - the APROPOS-II study.

BACKGROUND: In a previous feasibility study (APROPOS) in a single municipality of the Netherlands, we showed that a locally tailored preconception care (PCC) approach has the potential to positively affect preconceptional lifestyle behaviours. Therefore, we designed a second study (APROPOS-II) to obtain a more robust body of evidence: a larger group of respondents, more municipalities, randomization, and a more comprehensive set of (clinical) outcomes. The aim of this study is to assess the effectiveness and the implementation process of a local PCC-approach on preconceptional lifestyle behaviours, health outcomes and the reach of PCC among prospective parents and healthcare providers. METHODS: This study is an effectiveness-implementation hybrid type 2 trial. This involves a stepped-wedge cluster randomized controlled trial design aiming to include over 2000 future parents from six municipalities in the Netherlands. The intervention has a dual-track approach, focusing on both the uptake of PCC among future parents and the provision of PCC by healthcare providers. The PCC-approach consists of 1) a social marketing strategy directed towards prospective parent(s) and 2) a local care pathway to improve interdisciplinary collaboration. Data will be collected before and after the introduction of the intervention through questionnaires and medical records in each of the participating municipalities. The primary outcome of this study is change in lifestyle behaviours (e.g. folic acid use, smoking and alcohol use). Secondary outcomes are pregnancy outcomes (e.g. miscarriage, preterm birth, gestational diabetes) and the uptake of PCC. Moreover, a process evaluation will be performed, providing information on the efficacy, feasibility, barriers and facilitators regarding the implementation of the intervention. DISCUSSION: The APROPOS-II study introduces a locally tailored PCC-approach in six municipalities in the Netherlands that will contribute to the body of evidence regarding the effectiveness of PCC and its implementation. If this intervention has a positive effect on lifestyle behaviour changes, leading to improved pregnancy outcomes and the future health of prospective parents and their offspring, it could subsequently be upscaled to (inter)national implementation. TRIAL REGISTRATION: Dutch Trial register: NL7784 (Registered June 6th, 2019).