Cost-Effectiveness of Routine Third Trimester Ultrasound Screening for Fetal Growth Restriction Compared to Care as Usual in Low-Risk Pregnancies: A Pragmatic Nationwide Stepped-Wedge Cluster-Randomized Trial in The Netherlands (the IRIS Study).

Routine third trimester ultrasonography is increasingly used to screen for fetal growth restriction. However, evidence regarding its cost-effectiveness is lacking. We aimed to evaluate the cost-effectiveness of routine third trimester ultrasonography to reduce adverse perinatal outcomes compared to usual care (selective ultrasonography). An economic evaluation alongside a stepped-wedge cluster-randomized trial was conducted. Via 60 midwifery practices 12,974 Dutch women aged ≥16 years with low-risk pregnancies were enrolled at 22.8 (SD = 2.4) weeks' gestation. All practices provided usual care. At 3, 7, and 10 months a third of the practices were randomized to the intervention strategy providing routine ultrasonography at 28-30 and 34-36 weeks' gestation and usual care. The primary clinical outcome was a dichotomous composite measure of 12 severe adverse perinatal outcomes (SAPO) up to one week postpartum. Information on perinatal care and societal costs was derived from Netherlands Perinatal Registry, hospital records and a survey. Cost-effectiveness analyses revealed no significant differences in SAPO and healthcare and societal costs between the intervention strategy (n = 7026) and usual care (n = 5948). Cost-effectiveness acceptability curves showed that the probability of cost-effectiveness was never higher than 0.6 for all possible ceiling ratios. Adding routine third trimester ultrasonography to usual care is not cost-effective in reducing SAPO.

The effect of offering a third-trimester routine ultrasound on pregnancy-specific anxiety and mother-to-infant bonding in low-risk women: A pragmatic cluster-randomized controlled trial.

BACKGROUND: Third-trimester routine ultrasounds are increasingly offered to monitor fetal growth. In addition to limited evidence for its clinical effectiveness, little is known about its importance for pregnancy-specific anxiety and mother-to-infant bonding. METHODS: 1275 low-risk women participated in a Dutch nationwide pragmatic cluster-randomized trial and answered questionnaires on pregnancy-specific anxiety (PRAQ-R) and prenatal mother-to-infant bonding (MAAS) before and after a third-trimester routine ultrasound was offered to the intervention group. Linear mixed model regression analyses were performed to examine the effect of offering a third-trimester routine ultrasound on pregnancy-specific anxiety and mother-to-infant bonding. In addition, we examined whether the effect depended on maternal background characteristics and level of satisfaction with the ultrasound procedure. RESULTS: We found no effect of offering a third-trimester routine ultrasound on pregnancy-specific anxiety and mother-to-infant bonding. However, interaction analyses showed that women with high levels of depressive symptoms at baseline and women who were very satisfied with the ultrasound procedure benefited somewhat more from offering a third-trimester routine ultrasound in terms of mother-to-infant bonding compared with women with low or no depressive symptoms, or less satisfied women. CONCLUSIONS: The relationship between offering a third-trimester routine ultrasound with pregnancy-specific anxiety and mother-to-infant bonding is limited. A beneficial effect only applies to some subgroups of women. This implies that, in terms of psychological outcomes, there are no counterarguments to implementing a third-trimester routine ultrasound. Strong evidence for offering all pregnant women a third-trimester routine ultrasound for psychological reasons, however, is lacking.

Midwives' perceived barriers in communicating about depression with ethnic minority clients.

OBJECTIVE: This study aimed to assess the most influential barriers midwives perceive in communicating about depression-related symptoms with ethnic minority clients. METHODS: In-depth interviews were held with midwives (N = 8) and Moroccan-Dutch women (N = 6) suffering from perinatal depression to identify the most salient communication barriers. Subsequently, an online survey among midwives (N = 60) assessing their perceived barriers and the occurrence of these barriers in practice was administered. Composite scores using the QUOTE methodology were calculated to determine influential barriers. RESULTS: Three types of barriers emerged from the interviews. Educational-related barriers, client-related barriers and midwife-related barriers. Results of the survey showed that the most influential barriers were educational-related barriers (e.g. lack of culturally sensitive depression screening instruments) and client-related barriers (e.g. cultural taboo about talking about depression). CONCLUSION: Culturally sensitive screening instruments for depression and patient education materials should be developed to mitigate the educational-related barriers to communicating about depression. Patient education materials should also target the clients' social environment (e.g. husbands) to help break the cultural taboo about depression. PRACTICE IMPLICATIONS: Based on this study's results, communication strategies to empower both midwives and ethnic minority clients with depression can be developed in a collaborative approach.

Experiences of pregnant women with a third trimester routine ultrasound - a qualitative study.

BACKGROUND: Studies showed that pregnant women generally value routine ultrasounds in the first two trimesters because these provide reassurance and a chance to see their unborn baby. This, in turn, might help to decrease maternal anxiety levels and increase the bond with the baby. However, it is unclear whether pregnant women hold the same positive views about a third trimester routine ultrasound, which is increasingly being used in the Netherlands as a screening tool to monitor fetal growth. The aim of this study was to explore pregnant women's experiences with a third trimester routine ultrasound. METHODS: We held semi-structured interviews with fifteen low-risk pregnant women who received a third trimester routine ultrasound in the context of the Dutch IUGR RIsk Selection (IRIS) study. The IRIS study is a nationwide cluster randomized controlled trial carried out among more than 13,000 women to examine the effectiveness of a third trimester routine ultrasound to monitor fetal growth. For the interviews, participants were purposively selected based on parity, age, ethnicity, and educational level. We performed thematic content analysis using MAXQDA. RESULTS: Most pregnant women appreciated a third trimester routine ultrasound because it provided them confirmation that their baby was fine and an extra opportunity to see their baby. At the same time they expressed that they already felt confident about the health of their baby, and did not feel that their bond with their baby had increased after the third trimester ultrasound. Women also reported that they were getting used to routine ultrasounds throughout their pregnancy, and that this increased their need for another one. CONCLUSIONS: Pregnant women seem to appreciate a third trimester routine ultrasound, but it does not seem to reduce anxiety or to improve bonding with their baby. Women's appreciation of a third trimester routine ultrasound might arise from getting used to routine ultrasounds throughout pregnancy. We recommend to examine the psychological impact of third trimester routine ultrasounds in future studies. Results should be taken into consideration when balancing the gains, which are as yet not clear, of introducing a third trimester routine ultrasound against unwanted side effects and costs.

Correlates of prenatal and postnatal mother-to-infant bonding quality: A systematic review.

BACKGROUND: Mother-to-infant bonding is defined as the emotional tie experienced by a mother towards her child, which is considered to be important for the socio-emotional development of the child. Numerous studies on the correlates of both prenatal and postnatal mother-to-infant bonding quality have been published over the last decades. An up-to-date systematic review of these correlates is lacking, however. OBJECTIVE: To systematically review correlates of prenatal and postnatal mother-to-infant bonding quality in the general population, in order to enable targeted interventions. METHODS: MEDLINE, Embase, CINAHL, and PsychINFO were searched through May 2018. Reference checks were performed. Case-control, cross-sectional or longitudinal cohort studies written in English, German, Swedish, Spanish, Norwegian, French or Dutch defining mother-to-infant bonding quality as stipulated in the protocol (PROSPERO CRD42016040183) were included. Two investigators independently reviewed abstracts, full-text articles and extracted data. Methodological quality was assessed using the National Institute of Health Quality Assessment Tool for Observational Cohort and Cross-sectional studies and was rated accordingly as poor, fair or good. Clinical and methodological heterogeneity were examined. MAIN RESULTS: 131 studies were included. Quality was fair for 20 studies, and poor for 111 studies. Among 123 correlates identified, 3 were consistently associated with mother-to-infant bonding quality: 1) duration of gestation at assessment was positively associated with prenatal bonding quality, 2) depressive symptoms were negatively associated with postnatal mother-to-infant bonding quality, and 3) mother-to-infant bonding quality earlier in pregnancy or postpartum was positively associated with mother-to-infant bonding quality later in time. CONCLUSION: Our review suggests that professionals involved in maternal health care should consider monitoring mother-to-infant bonding already during pregnancy. Future research should evaluate whether interventions aimed at depressive symptoms help to promote mother-to-infant bonding quality. More high-quality research on correlates for which inconsistent results were found is needed.

Multidisciplinary consensus on screening for, diagnosis and management of fetal growth restriction in the Netherlands.

BACKGROUND: Screening for, diagnosis and management of intrauterine growth restriction (IUGR) is often performed in multidisciplinary collaboration. However, variation in screening methods, diagnosis and management of IUGR may lead to confusion. In the Netherlands two monodisciplinary guidelines on IUGR do not fully align. To facilitate effective collaboration between different professionals in perinatal care, we undertook a Delphi study with uniform recommendations as our primary result, focusing on issues that are not aligned or for which specifications are lacking in the current guidelines. METHODS: We conducted a Delphi study in three rounds. A purposively sampled selection of 56 panellists participated: 27 representing midwife-led care and 29 obstetrician-led care. Consensus was defined as agreement between the professional groups on the same answer and among at least 70% of the panellists within groups. RESULTS: Per round 51 or 52 (91% - 93%) panellists responded. This has led to consensus on 27 issues, leading to four consensus based recommendations on screening for IUGR in midwife-led care and eight consensus based recommendations on diagnosis and eight on management in obstetrician-led care. The multidisciplinary project group decided on four additional recommendations as no consensus was reached by the panel. No recommendations could be made about induction of labour versus expectant monitoring, nor about the choice for a primary caesarean section. CONCLUSIONS: We reached consensus on recommendations for care for IUGR within a multidisciplinary panel. These will be implemented in a study on the effectiveness and cost-effectiveness of routine third trimester ultrasound for monitoring fetal growth. Research is needed to evaluate the effects of implementation of these recommendations on perinatal outcomes. TRIAL REGISTRATION: NTR4367 .

Pregnancy-specific anxiety and its association with background characteristics and health-related behaviors in a low-risk population.

BACKGROUND: Pregnancy-specific anxiety is an important risk factor for adverse pregnancy outcomes. It is therefore needed to gain insight in which women are at risk for elevated levels (> 85th percentile) of pregnancy-specific anxiety. Additionally, given that unhealthy behaviour has been suggested as a possible pathway linking pregnancy-specific anxiety to adverse pregnancy outcomes, it is important to examine whether higher levels of pregnancy-specific anxiety are associated with negative health-related behaviours (smoking, alcohol use and too much weight gain). METHODS: Using a study sample of 4541 low-risk pregnant women who filled in the Pregnancy Related Anxiety Questionnaire-Revised (PRAQ-R), we first examined which socio-demographic, pregnancy-related and psychological background characteristics were significantly associated with a PRAQ-R score above the 85th percentile. Secondly, we examined the association between pregnancy-specific anxiety and self-reported health-related behaviours (smoking, alcohol use and too much weight gain) while controlling for significant background characteristics. For both research questions, backward regression analysis was applied. RESULTS: Results showed that nulliparity (OR=2.33, 95% confidence interval (CI)=1.97-2.77), anxious or depressed mood (OR=3.29, 95% CI=2.74-3.94) and non-Dutch ethnicity, especially Turkish (OR=3.47, 95% CI=2.16-5.59) or Moroccan (OR=2.97, 95% CI=1.84-4.81), were most strongly associated with elevated pregnancy-specific anxiety levels. Women with higher pregnancy-specific anxiety levels were more likely to gain too much weight during pregnancy (odds ratio (OR) linear term=1.49, 95% CI=1.21-1.83), while both very low and high levels of pregnancy-specific anxiety were associated with smoking (OR linear term=0.13, 95% CI=0.04-0.45, OR quadratic term=1.81, 95% CI=1.32-2.47). No association with alcohol use was found. CONCLUSIONS: In conclusion, our results show nulliparity, anxious or depressed mood and non-Dutch ethnicity as three major vulnerability factors for elevated levels of pregnancy-specific anxiety. Furthermore, our results show an association between pregnancy-specific anxiety and negative health-related behaviours, which is worth examining in future studies.

Effectiveness and cost-effectiveness of routine third trimester ultrasound screening for intrauterine growth restriction: study protocol of a nationwide stepped wedge cluster-randomized trial in The Netherlands (The IRIS Study).

BACKGROUND: Intrauterine growth retardation (IUGR) is a major risk factor for perinatal mortality and morbidity. Thus, there is a compelling need to introduce sensitive measures to detect IUGR fetuses. Routine third trimester ultrasonography is increasingly used to detect IUGR. However, we lack evidence for its clinical effectiveness and cost-effectiveness and information on ethical considerations of additional third trimester ultrasonography. This nationwide stepped wedge cluster-randomized trial examines the (cost-)effectiveness of routine third trimester ultrasonography in reducing severe adverse perinatal outcome through subsequent protocolized management. METHODS: For this trial, 15,000 women with a singleton pregnancy receiving care in 60 participating primary care midwifery practices will be included at 22 weeks of gestation. In the intervention (n = 7,500) and control group (n = 7,500) fetal growth will be monitored by serial fundal height assessments. All practices will start offering the control condition (ultrasonography based on medical indication). Every three months, 20 practices will be randomized to the intervention condition, i.e. apart from ultrasonography if indicated, two routine ultrasound examinations will be performed (at 28-30 weeks and 34-36 weeks). If IUGR is suspected, both groups will receive subsequent clinical management as described in the IRIS study protocol that will be developed before the start of the trial. The primary dichotomous clinical composite outcome is 'severe adverse perinatal outcome' up to 7 days after birth, including: perinatal death; Apgar score <4 at 5 minutes after birth; impaired consciousness; need for assisted ventilation for more than 24 h; asphyxia; septicemia; meningitis; bronchopulmonary dysplasia; intraventricular hemorrhage; cystic periventricular leukomalacia; neonatal seizures or necrotizing enterocolitis. For the economic evaluation, costs will be measured from a societal perspective. Quality of life will be measured using the EQ-5D-5 L to enable calculation of QALYs. Cost-effectiveness and cost-utility analyses will be performed. In a qualitative sub-study (using diary notes from 32 women for 9 months, at least 10 individual interviews and 2 focus group studies) we will explore ethical considerations of additional ultrasonography and how to deal with them. DISCUSSION: The results of this trial will assist healthcare providers and policymakers in making an evidence-based decision about whether or not introducing routine third trimester ultrasonography. TRIAL REGISTRATION: NTR4367 , 21 March 2014.

Factorial invariance of pregnancy-specific anxiety dimensions across nulliparous and parous pregnant women.

The 10-item version of the Pregnancy-Related Anxiety Questionnaire-Revised was developed based on a sample of nulliparous women. Whether this measure is also a valuable tool for future research on pregnancy-specific anxiety is unclear. Our study tested for invariance of this measure across nulliparous women and parous women by using a dataset of 6004 women pregnant up to 35 weeks. Results showed that whereas the factor structure of the 10-item version of the Pregnancy-Related Anxiety Questionnaire-Revised was noninvariant, removing item 8 from the measure created a measure with invariant factor loadings that can be used for all pregnant women.

Opinions of maternity care professionals about integration of care during labor for "moderate risk" indications: a Delphi study in the Netherlands.

BACKGROUND: The percentage of referrals during labor from primary midwife-led care to obstetrician-led care has increased over the past years in The Netherlands. Most women are referred for indications with a moderate increase in risk and are looked after by clinical midwives. This study aims to provide insight into the opinions of maternity care professionals about integration of care and involvement of primary care midwives in the intrapartum care of women with "moderate risk" factors. METHODS: A Delphi study consisting of three rounds was conducted. A purposively selected heterogenic panel of 50 professionals, including obstetricians, primary care midwives, clinical midwives, and obstetric nurses, answered questions anonymously. RESULTS: Although primary care midwives would like to expand their responsibilities and tasks with respect to "moderate risk" indications, consensus among panel members was only reached concerning prolonged rupture of membranes for which the primary care midwife could remain the caregiver. CONCLUSION: This study shows that most participants support more integration of care during labor. The lack of consensus among Dutch maternity care professionals with regard to the distribution of responsibilities and tasks for "moderate risk" indications is a challenge. Further studies should explore how to deal with differences in opinions among professionals when integrating maternity care systems.

Perinatal mortality rate in the Netherlands compared to other European countries: a secondary analysis of Euro-PERISTAT data.

OBJECTIVE: the poor perinatal mortality ranking of the Netherlands compared to other European countries has led to questioning the safety of primary care births, particularly those at home. Primary care births are only planned at term. We therefore examined to which extent the perinatal mortality rate at term in the Netherlands contributes to its poor ranking. DESIGN: secondary analyses using published data from the Euro-PERISTAT study. SETTING AND PARTICIPANTS: women that gave birth in 2004 in the 29 European regions and countries called 'countries' included in the Euro-PERISTAT study (4,328,441 women in total and 1,940,977 women at term). METHODS: odds ratios and 95% confidence intervals were calculated for the comparison of perinatal mortality rates between European countries and the Netherlands, through logistic regression analyses using summary country data. MAIN OUTCOME MEASURES: combined perinatal mortality rates overall and at term. Perinatal deaths below 28 weeks, between 28 and 37 weeks and from 37 weeks onwards per 1000 total births. FINDINGS: compared to the Netherlands, perinatal mortality rates at term were significantly higher for Denmark and Latvia and not significantly different compared to seven other countries. Eleven countries had a significantly lower rate, and for eight the term perinatal mortality rate could not be compared. The Netherlands had the highest number of perinatal deaths before 28 weeks per 1000 total births (4.3). KEY CONCLUSIONS: the relatively high perinatal mortality rate in the Netherlands is driven more by extremely preterm births than births at term. Although the PERISTAT data cannot be used to show that the Dutch maternity care system is safe, neither should they be used to argue that the system is unsafe. The PERISTAT data alone do not support changes to the Dutch maternity care system that reduce the possibility for women to choose a home birth while benefits of these changes are uncertain.

Prioritization of future genetics education for general practitioners: a Delphi study.

PURPOSE: General practitioners (GPs) are increasingly expected to deliver genetics services in daily patient care. Education in primary care genetics is considered suboptimal and in urgent need of revision and innovation. The aim of this study was to prioritize topics for genetics education for general practice. METHODS: A Delphi consensus procedure consisting of three rounds was conducted. A purposively selected heterogeneous panel (n = 18) of experts, comprising six practicing GPs who were also engaged in research, five GP trainers, four clinical genetics professionals, and three representatives of patient organizations, participated. Educational needs regarding genetics in general practice in terms of knowledge, skills, and attitudes were rated and ranked in a top-10 list. RESULTS: The entire panel completed all three rounds. Kendall's coefficient of concordance indicated significant agreement regarding the top 10 genetic education needs (P < 0.001). "Recognizing signals that are potentially indicative of a hereditary component of a disease" was rated highest, followed by "Evaluating indications for referral to a clinical genetics centre" and "Knowledge of the possibilities and limitations of genetic tests." CONCLUSIONS: The priorities resulting from this study can inform the development of educational modules, including input for case-based education, to improve GP performance in genetic patient care.