Evaluation and patient experience of wireless noninvasive fetal heart rate monitoring devices.

INTRODUCTION: In clinical practice, fetal heart rate monitoring is performed intermittently using Doppler ultrasound, typically for 30 minutes. In case of a non-reassuring heart rate pattern, monitoring is usually prolonged. Noninvasive fetal electrocardiography may be more suitable for prolonged monitoring due to improved patient comfort and signal quality. This study evaluates the performance and patient experience of four noninvasive electrocardiography devices to assess candidate devices for prolonged noninvasive fetal heart rate monitoring. MATERIAL AND METHODS: Non-critically sick women with a singleton pregnancy from 24 weeks of gestation were eligible for inclusion. Fetal heart rate monitoring was performed during standard care with a Doppler ultrasound device (Philips Avalon-FM30) alone or with this Doppler ultrasound device simultaneously with one of four noninvasive electrocardiography devices (Nemo Fetal Monitoring System, Philips Avalon-Beltless, Demcon Dipha-16 and Dräger Infinity-M300). Performance was evaluated by: success rate, positive percent agreement, bias, 95% limits of agreement, regression line, root mean square error and visual agreement using FIGO guidelines. Patient experience was captured using a self-made questionnaire. RESULTS: A total of 10 women were included per device. For fetal heart rate, Nemo performed best (success rate: 99.4%, positive percent agreement: 94.2%, root mean square error 5.1 BPM, bias: 0.5 BPM, 95% limits of agreement: -9.7 - 10.7 BPM, regression line: y = -0.1x + 11.1) and the cardiotocography tracings obtained simultaneously by Nemo and Avalon-FM30 received the same FIGO classification. Comparable results were found with the Avalon-Beltless from 36 weeks of gestation, whereas the Dipha-16 and Infinity-M300 performed significantly worse. The Avalon-Beltless, Nemo and Infinity-M300 closely matched the performance of the Avalon-FM30 for maternal heart rate, whereas the performance of the Dipha-16 deviated more. Patient experience scores were higher for the noninvasive electrocardiography devices. CONCLUSIONS: Both Nemo and Avalon-Beltless are suitable devices for (prolonged) noninvasive fetal heart rate monitoring, taking their intended use into account. But outside its intended use limit of 36 weeks' gestation, the Avalon-Beltless performs less well, comparable to the Dipha-16 and Infinity-M300, making them currently unsuitable for (prolonged) noninvasive fetal heart rate monitoring. Noninvasive electrocardiography devices appear to be preferred due to greater comfort and mobility.

Actions for mitigating the negative effects of patient participation in patient safety: a qualitative study.

BACKGROUND: Recent research within the context of Obstetrics shows the added value of patient participation in in-hospital patient safety. Notwithstanding these benefits, recent research within an Obstetrics department shows that four different negative effects of patient participation in patient safety have emerged. However, the approach to addressing these negative effects within the perspective of patient participation in patient safety is currently lacking. For this reason, the aim of this study is to generate an overview of actions that could be taken to mitigate the negative effects of patient participation in patient safety within an Obstetrics department. METHODS: This study was conducted in the Obstetrics Department of a tertiary academic center. An explorative qualitative interview study included sixteen interviews with professionals (N = 8) and patients (N = 8). The actions to mitigate the negative effects of patient participation in patient safety, were analyzed and classified using a deductive approach. RESULTS: Eighteen actions were identified that mitigated the negative effects of patient participation in patient safety within an Obstetrics department. These actions were categorized into five themes: 'structure', 'culture', 'education', 'emotional', and 'physical and technology'. These five categories reflect the current approach to improving patient safety which is primarily viewed from the perspective of professionals rather than of patients. CONCLUSIONS: Most of the identified actions are linked to changing the culture to generate more patient-centered care and change the current reality, which looks predominantly from the perspective of the professionals and too little from that of the patients. Furthermore, none of the suggested actions fit within a sixth anticipated category, namely, 'politics'. Future research should explore ways to implement a patient-centered care approach based on these actions. By doing so, space, money and time have to be created to elaborate on these actions and integrate them into the organizations' structure, culture and practices.

Continuous glucose monitoring metrics and pregnancy outcomes in insulin-treated diabetes: A post-hoc analysis of the GlucoMOMS trial.

AIM: To investigate the association between continuous glucose monitoring (CGM) metrics and perinatal outcomes in insulin-treated diabetes mellitus in pregnancy. MATERIALS AND METHODS: In a post-hoc analysis of the GlucoMOMS randomized controlled trial, we investigated the association between the metrics of an offline, intermittent CGM, glycated haemoglobin (HbA1c) and perinatal outcomes per trimester in different types of diabetes (type 1, 2 or insulin-treated gestational diabetes mellitus [GDM]). Data were analysed using multivariable binary logistic regression. Outcomes of interest were neonatal hypoglycaemia, pre-eclampsia, preterm birth, large for gestational age (LGA) and Neonatal Intensive Care Unit (NICU) admission. The glucose target range was defined as 3.5-7.8 mmol/L (63-140 mg/dL). RESULTS: Of the 147 participants (N = 50 type 1 diabetes, N = 94 type 2 diabetes/insulin-treated GDM) randomized to the CGM group of the GlucoMOMS trial, 115 participants had CGM metrics available and were included in the current study. We found that, in pregnancies with type 1 diabetes, a higher second trimester mean glucose was associated with LGA (odds ratio 2.6 [95% confidence interval 1.1-6.2]). In type 2 and insulin-treated gestational diabetes, an increased area under the curve above limit was associated with LGA (odds ratio 10.0 [95% confidence interval 1.4-72.8]). None of the CGM metrics were associated with neonatal hypoglycaemia, pre-eclampsia, shoulder dystocia, preterm birth and NICU admission rates for pregnancies complicated by any type of diabetes. CONCLUSION: In this study, in type 2 diabetes or insulin-treated GDM, the glucose increased area under the curve above limit was associated with increased LGA. In type 1 diabetes, the mean glucose was the major determinant of LGA. Our study found no evidence that other CGM metrics determined adverse pregnancy outcomes.

Long-term quality of life after obstetric intensive care unit admission: A cross-sectional cohort study.

OBJECTIVE: To assess the long-term quality of life (QoL) after obstetric Intensive Care Unit (ICU) admission. DESIGN: Cross-sectional survey study. SETTING: Tertiary care centre. POPULATION: Women admitted to the level 3 ICU during pregnancy or ≤6 weeks postpartum, between 2000 and 2015. METHODS: Quality of life measures were compared with the population reference values. Associations with baseline ICU parameters were assessed with multivariable linear regression. Patient-reported outcome and experience measures (PROMs/PREMs) were described. MAIN OUTCOME MEASURES: Quality of life according to the Linear Analogous Scale (LAS), the Satisfaction with Life Scale (SWLS) and the SF-36 questionnaire; PROMs/PREMs using the Pregnancy and Childbirth outcome set of the International Consortium for Health Outcomes Measurement. RESULTS: Of all 265 obstetric ICU admissions, 230 were eligible and 94 (41%) were included (median follow-up time 14 years). The LAS (75.7 versus 78.7, p = 0.077) and SWLS (25.2 versus 26, p = 0.176) sum scores were not different from the population reference values. The SF-36 subdomains bodily pain (55.3 versus 73.9), general health (58.2 versus 73.9) and vitality (56.9 versus 69.1) were lower than the reference values (all p < 0.001). PROMs/PREMs were low in 46.2% for pain, 15.1% for depression, 11.8% for satisfaction with care and 52.7% for healthcare responsiveness. An indirect obstetric ICU admission diagnosis was independently associated with a reduced physical health score (B -1.7, 95% confidence interval [CI] -3.4 to -0.1) and severe neonatal morbidity with a reduced mental health score (B -6.6, 95% CI -11.3 to -1.8). CONCLUSION: Obstetric ICU admission is associated with reductions in long-term physical health QoL and in some patients with mental health QoL. We suggest multidisciplinary rehabilitation and long-term psychosocial support.

Termination of pregnancy after a prenatal diagnosis of congenital diaphragmatic hernia: Factors influencing the parental decision process.

OBJECTIVE: To evaluate the incidence of termination of pregnancies (TOP) and factors associated with the decision for TOP in prenatally detected congenital diaphragmatic hernia (CDH). STUDY DESIGN: Single-centre retrospective cohort includes all prenatally detected CDH cases born between January 2009 and December 2021. Parental factors, such as parity, and fetal characteristics, such as disease severity, were collected. Descriptive statistics were used to present the data. Differences between terminated and continued pregnancies were analysed. RESULTS: The study population consisted of 278 prenatally detected CDH cases of which 80% detected <24 weeks of gestation. The TOP rate was 28% in cases that were detected <24 weeks of gestation. Twenty continued pregnancies resulted in either intrauterine fetal demise (n = 6), preterm birth <24 weeks (n = 2), or comfort care after birth (n = 12). The survival rate was 70% in the remaining 195 live born cases. Factors associated with the decision for TOP were additional fetal genetic or anatomical abnormalities (p < 0.0001) and expected severity of pulmonary hypoplasia in left-sided CDH (p = 0.0456). CONCLUSION: The decision to terminate a pregnancy complicated by fetal CDH depends on the severity of pulmonary hypoplasia and the presence of additional abnormalities. This emphasises the importance of early referral to expertise centres for detailed evaluation and multidisciplinary counselling.

A web-based decision aid for shared decision making in pelvic organ prolapse: the SHADE-POP trial.

INTRODUCTION AND HYPOTHESIS: Among women worldwide, pelvic organ prolapse (POP) is a common problem. There are three different treatment options for POP: pelvic floor muscle therapy, pessary treatment and prolapse surgery. As none of the three treatment options is clearly superior, shared decision making (SDM) is very important. A decision aid (DA) is known to facilitate patient participation and SDM. We hypothesise that the use of a web-based DA for POP increases patients' satisfaction with information and care and reduces decisional conflict. METHODS: This two-arm, multicentre, cluster randomised controlled trial was performed in women with POP in five different Dutch hospitals. The control group received usual care (UC) and the intervention group received the DA in addition to UC. Primary outcome measures were satisfaction with treatment decision making and satisfaction with information. Analyses were performed using independent sample t tests, Chi-squared tests, and multilevel linear regression analyses. RESULTS: Between the DA group (n=40) and the UC group (n=56) no differences were found concerning patients' satisfaction with information, with scores of 45.63 and 46.14 out of 50 respectively (p=0.67). Also, no differences were found concerning the perceived role in decision making, as patients scored 46.83 in the DA group and 46.41 in the UC group, out of a maximum of 54 (n=0.81). CONCLUSIONS: No differences were found concerning patients' satisfaction with information and treatment decision making between the DA and UC. However, both groups scored high on the questionnaires, which suggests that the decision process is already of high quality.

Perinatal mortality and neonatal and maternal outcome per gestational week in term pregnancies: A registry-based study.

INTRODUCTION: Human pregnancy is considered term from 37+0/7 to 41+6/7 weeks. Within this range, both maternal, fetal and neonatal risks may vary considerably. This study investigates how gestational age per week is related to the components of perinatal mortality and parameters of adverse neonatal and maternal outcome at term. MATERIAL AND METHODS: A registry-based study was made of all singleton term pregnancies in the Netherlands from January 2014 to December 2017. Stillbirth and early neonatal mortality, as components of perinatal mortality, were defined as primary outcomes; adverse neonatal and maternal events as secondary outcomes. Neonatal adverse outcomes included birth trauma, 5-minute Apgar score ≤3, asphyxia, respiratory insufficiency, neonatal intensive care unit admission and composite neonatal outcome. Maternal adverse outcomes included instrumental vaginal birth, emergency cesarean section, obstetric anal sphincter injury, postpartum hemorrhage, hypertensive disorders of pregnancy and composite maternal outcome. The primary outcomes were evaluated by comparing weekly prospective risks of stillbirth and neonatal death using a fetuses-at-risk approach. Secondly, odds ratios (OR) for perinatal mortality, adverse neonatal and maternal outcome using a births-based approach were compared for each gestational week with all births occurring after that week. RESULTS: Data of 581 443 births were analyzed. At 37, 38, 39, 40, 41 and 42 weeks, the respective weekly prospective risks of stillbirth were 0.015%, 0.022%, 0.031%, 0.036%, 0.069% and 0.081%; the respective weekly prospective risks of early neonatal death were 0.051%, 0.047%, 0.032%, 0.031%, 0.039% and 0.035%. The OR for adverse neonatal outcomes were the lowest at 39 and 40 weeks. The OR for adverse maternal outcomes, including operative birth, continuously increased with each gestational week. CONCLUSIONS: The prospective risk of early neonatal death for babies born at 39 weeks is lower than the risk of stillbirth in pregnancies continuing beyond 39+6/7 weeks. Birth at 39 weeks was associated with the best combined neonatal and maternal outcome, fewer operative births and fewer maternal and neonatal adverse outcomes compared with pregnancies continuing beyond 39 weeks. This information with appropriate perspectives should be included when counseling term pregnant women.

Provision and experience of care among women with hypertension in pregnancy: a multi-center qualitative study in Ghana.

BACKGROUND: Hypertensive disorders of pregnancy (HDP) remain a leading global health problem with complex clinical presentations and potentially grim birth outcomes for both mother and fetus. Improvement in the quality of maternal care provision and positive women's experiences are indispensable measures to reduce maternal and perinatal adverse outcomes. OBJECTIVE: To explore the perspectives and lived experiences of healthcare provision among women with HDP and the associated challenges. METHODS: A multi-center qualitative study using in-depth interviews (IDIs) and focus group discussions (FGDs) was conducted in five major referral hospitals in the Greater Accra Region of Ghana between June 2018 and March 2019. Women between 26 and 34 weeks' gestation with confirmed HDP who received maternity care services were eligible to participate. Thematic content analysis was performed using the inductive analytic framework approach. RESULTS: Fifty IDIs and three FGDs (with 22 participants) were conducted. Most women were between 20 and 30 years, Akans (ethnicity), married/cohabiting, self-employed and secondary school graduates. Women reported mixed (positive and negative) experiences of maternal care. Positive experiences reported include receiving optimal quality of care, satisfaction with care and good counselling and reassurance from the health professionals. Negative experiences of care comprised ineffective provider-client communication, inappropriate attitudes by the health professionals and disrespectful treatment including verbal and physical abuse. Major health system factors influencing women's experiences of care included lack of logistics, substandard professionalism, inefficient national health insurance system and unexplained delays at health facilities. Patient-related factors that influenced provision of care enumerated were financial limitations, chronic psychosocial stress and inadequate awareness about HDP. CONCLUSION: Women with HDP reported both positive and negative experiences of care stemming from the healthcare system, health providers and individual factors. Given the importance of positive women's experiences and respectful maternal care, dedicated multidisciplinary women-centered care is recommended to optimize the care for pregnant women with HDP.

High blood pressure (hypertension) in pregnancy can have severe complications for both mother and fetus including loss of life. The outcome of pregnancy for women who develop hypertension during pregnancy can be improved by ensuring optimal quality of care. In this study, we explored the opinions and experiences of women whose pregnancies were affected by hypertension concerning the care they received during their recent admission at different hospitals in Ghana and the challenges they faced. In four major referral hospitals in the Greater Accra Region of Ghana, we interviewed the women and had focus group discussions. Women who were pregnant for 26 weeks up to 34 weeks and had hypertension in pregnancy were invited for inclusion in the study.We conducted in-depth interviews with fifty women and three focus group discussions with 22 women. Most women who participated in the study were between 20 and 30 years old, Akans (ethnicity), married/cohabiting, self-employed and secondary school graduates. The women reported both positive and negative experiences of care during their admission at the hospitals. Examples of positive experiences were receiving good quality of care, satisfaction with care, and adequate counselling from the health workers. Examples of negative experiences were poor communication between the providers and affected women, inappropriate attitudes by the healthcare providers, and disrespectful treatment such as verbal and physical abuse. The major factors in the health system that influenced women's experiences of care were lack of logistics, substandard professionalism, inefficient national health insurance system and long delays at health facilities prior to receiving treatment. The individual women's factors that affected the quality of care included financial constraints, psychosocial stress and inadequate knowledge about hypertension during pregnancy.In conclusion, we determined that women with hypertension in pregnancy experience both positive and negative aspects of care and these may be due to challenges associated with the healthcare system, health providers and women themselves. There is the need to ensure optimal quality and respectful maternity care considering the nature of hypertension in pregnancy. These women require dedicated hospital staff with significant  experience to improve the quality of care provided to women with hypertension in pregnancy.

Hypertensive disorders of pregnant women with heart disease: the ESC EORP ROPAC Registry.

AIMS: Hypertensive disorders of pregnancy (HDP) occur in 10% of pregnancies in the general population, pre-eclampsia specifically in 3-5%. Hypertensive disorders of pregnancy may have a high prevalence in, and be poorly tolerated by, women with heart disease. METHODS AND RESULTS: The prevalence and outcomes of HDP (chronic hypertension, gestational hypertension or pre-eclampsia) were assessed in the ESC EORP ROPAC (n = 5739), a worldwide prospective registry of pregnancies in women with heart disease.The overall prevalence of HDP was 10.3%, made up of chronic hypertension (5.9%), gestational hypertension (1.3%), and pre-eclampsia (3%), with significant differences between the types of underlying heart disease (P < 0.05). Pre-eclampsia rates were highest in women with pulmonary arterial hypertension (PAH) (11.1%), cardiomyopathy (CMP) (7.1%), and ischaemic heart disease (IHD) (6.3%). Maternal mortality was 1.4 and 0.6% in women with vs. without HDP (P = 0.04), and even 3.5% in those with pre-eclampsia. All pre-eclampsia-related deaths were post-partum and 50% were due to heart failure. Heart failure occurred in 18.5 vs. 10.6% of women with vs. without HDP (P < 0.001) and in 29.1% of those with pre-eclampsia. Perinatal mortality was 3.1 vs. 1.7% in women with vs. without HDP (P = 0.019) and 4.7% in those with pre-eclampsia. CONCLUSION: Hypertensive disorders of pregnancy and pre-eclampsia rates were higher in women with CMP, IHD, and PAH than in the general population. Adverse outcomes were increased in women with HDP, and maternal mortality was strikingly high in women with pre-eclampsia. The combination of HDP and heart disease should prompt close surveillance in a multidisciplinary context and the diagnosis of pre-eclampsia requires hospital admission and continued monitoring during the post-partum period.

Associations of severe adverse perinatal outcomes among continuous birth weight percentiles on different birth weight charts: a secondary analysis of a cluster randomized trial.

OBJECTIVE: To identify neonatal risk for severe adverse perinatal outcomes across birth weight centiles in two Dutch and one international birth weight chart. BACKGROUND: Growth restricted newborns have not reached their intrinsic growth potential in utero and are at risk of perinatal morbidity and mortality. There is no golden standard for the confirmation of the diagnosis of fetal growth restriction after birth. Estimated fetal weight and birth weight below the 10th percentile are generally used as proxy for growth restriction. The choice of birth weight chart influences the specific cut-off by which birth weight is defined as abnormal, thereby triggering clinical management. Ideally, this cut-off should discriminate appropriately between newborns at low and at high risk of severe adverse perinatal outcomes and consequently correctly inform clinical management. METHODS: This is a secondary analysis of the IUGR Risk Selection (IRIS) study. Newborns (n = 12 953) of women with a low-risk status at the start of pregnancy and that received primary antenatal care in the Netherlands were included. We examined the distribution of severe adverse perinatal outcomes across birth weight centiles for three birth weight charts (Visser, Hoftiezer and INTERGROWTH) by categorizing birth weight centile groups and comparing the prognostic performance for severe adverse perinatal outcomes. Severe adverse perinatal outcomes were defined as a composite of one or more of the following: perinatal death, Apgar score < 4 at 5 min, impaired consciousness, asphyxia, seizures, assisted ventilation, septicemia, meningitis, bronchopulmonary dysplasia, intraventricular hemorrhage, periventricular leukomalacia, or necrotizing enterocolitis. RESULTS: We found the highest rates of severe adverse perinatal outcomes among the smallest newborns (< 3rd percentile) (6.2% for the Visser reference curve, 8.6% for the Hoftiezer chart and 12.0% for the INTERGROWTH chart). Discriminative abilities of the three birth weight charts across the entire range of birth weight centiles were poor with areas under the curve ranging from 0.57 to 0.61. Sensitivity rates of the various cut-offs were also low. CONCLUSIONS: The clinical utility of all three charts in identifying high risk of severe adverse perinatal outcomes is poor. There is no single cut-off that discriminates clearly between newborns at low or high risk. TRIAL REGISTRATION: Netherlands Trial Register NTR4367 . Registration date March 20th, 2014.

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.

Maternal characteristics as indications for routine induction of labor: A nationwide retrospective cohort study.

BACKGROUND: Maternal characteristics, such as parity and age, are increasingly considered indications for routine induction of labor of otherwise healthy women to prevent fetal and neonatal mortality. To fully balance the risks and benefits of induction of labor, we examined the association of additional relevant maternal characteristics and gestational age with fetal and neonatal mortality. METHODS: We conducted a nationwide retrospective cohort study among a healthy Dutch population consisting of all singleton pregnancies in midwife-led care after 37 weeks of gestation in the period 2000-2018. We examined the association of maternal ethnicity, age, parity, and socioeconomic status with fetal and neonatal mortality, stratified by gestational age. The association of single characteristics was examined using descriptive statistics, and univariable and multivariable logistics regression analyses. The associations of multiple characteristics were examined using inter-categorical analyses and using interaction terms in the multivariable logistic regression analyses. RESULTS: The results showed that ethnicity, age, parity, socioeconomic status, and gestational age did not act as single determinant of fetal and neonatal mortality. The probability of fetal and neonatal mortality differed among subgroups of women depending on which determinants were considered and the number of determinants included. CONCLUSIONS: Decision-making about induction of labor to prevent fetal and neonatal mortality based on a single determinant may lead to overuse or underuse of IOL. A value-based health care strategy, addressing social inequity, and investing in better screening and diagnostic methods that employ an individualized and multi-determinant approach may be more effective at preventing fetal and neonatal mortality.

Patient-Reported Outcome and Experience Measures in Perinatal Care to Guide Clinical Practice: Prospective Observational Study.

BACKGROUND: The International Consortium for Health Outcomes Measurement has published a set of patient-centered outcome measures for pregnancy and childbirth (PCB set), including patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs). To establish value-based pregnancy and childbirth care, the PCB set was implemented in the Netherlands, using the outcomes on the patient level for shared decision-making and on an aggregated level for quality improvement. OBJECTIVE: This study aims to report first outcomes, experiences, and practice insights of implementing the PCB set in clinical practice. METHODS: In total, 7 obstetric care networks across the Netherlands, each consisting of 1 or 2 hospitals and multiple community midwifery practices (ranging in number from 2 to 18), implemented the PROM and PREM domains of the PCB set as part of clinical routine. This observational study included all women participating in the clinical project. PROMs and PREMs were assessed with questionnaires at 5 time points: 2 during pregnancy and 3 post partum. Clinical threshold values (alerts) supported care professionals interpreting the answers, indicating possibly alarming outcomes per domain. Data collection took place from February 2020 to September 2021. Data analysis included missing (pattern) analysis, sum scores, alert rates, and sensitivity analysis. RESULTS: In total, 1923 questionnaires were collected across the 5 time points: 816 (42.43%) at T1 (first trimester), 793 (41.23%) at T2 (early third trimester), 125 (6.5%) at T3 (maternity week), 170 (8.84%) at T4 (6 weeks post partum), and 19 (1%) at T5 (6 months post partum). Of these, 84% (1615/1923) were filled out completely. Missing items per domain ranged from 0% to 13%, with the highest missing rates for depression, pain with intercourse, and experience with pain relief at birth. No notable missing patterns were found. For the PROM domains, relatively high alert rates were found both in pregnancy and post partum for incontinence (469/1798, 26.08%), pain with intercourse (229/1005, 22.79%), breastfeeding self-efficacy (175/765, 22.88%), and mother-child bonding (122/288, 42.36%). Regarding the PREM domains, the highest alert rates were found for birth experience (37/170, 21.76%), shared decision-making (101/982, 10.29%), and discussing pain relief ante partum (310/793, 39.09%). Some domains showed very little clinical variation; for example, role of the mother and satisfaction with care. CONCLUSIONS: The PCB set is a useful tool to assess patient-reported outcomes and experiences that need to be addressed over the whole course of pregnancy and childbirth. Our results provide opportunities to improve and personalize perinatal care. Furthermore, we could propose several recommendations regarding methods and timeline of measurements based on our findings. This study supports the implementation of the PCB set in clinical practice, thereby advancing the transformation toward patient-centered, value-based health care for pregnancy and childbirth.

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.

Too busy to care? Analysing the impact of system-related factors on maternal mortality in Zanzibar's Referral Hospital.

This study analyses the contribution of system-related factors to maternal mortality in the low-resource setting of Mnazi Mmoja Hospital in Zanzibar, Tanzania. It is a retrospective cohort study including all maternal deaths (MD, n = 139) and maternal near-misses (MNM, n = 122) in Mnazi Mmoja Hospital with sufficient documentation during 2015 to 2018 (MD) and 2017 to 2018 (MNM). The number of admissions and surgical interventions per health care provider on the day of admission and the number of times vital signs were monitored per day were compared between MNM and MD cases using logistic regression. The mean number of times vital signs were monitored per day was associated with reduced odds of mortality (aOR 0.75, 95% CI 0.64-0.89), after adjustment for confounding factors such as severity of illness. The numbers of admissions or surgical procedures per health care provider were not associated with mortality. Concluding, the degree of monitoring of patients with life-threatening complications of pregnancy or childbirth is associated with the risk of mortality independent of the degree of severity. Preventing maternal mortality requires going beyond availability of essential interventions to tackle system-related factors that have a direct impact on the capacity to provide comprehensive care.Impact StatementWhat is already known on this subject? Root cause analyses of maternal deaths have identified many system-related factors, such as availability of health care providers, adequate training, and motivation to sustain high intensity monitoring (Madzimbamuto et al. 2014; Mahmood et al. 2018).What do the results of this study add? This is the first study to attempt to quantify the contribution of these system-related factors by comparing cases of maternal death with cases of maternal near-miss. We show that the degree of monitoring of patients with life-threatening complications is associated with the odds of mortality independent of the degree of severity. Even though this relation should not be regarded as causative, monitoring of vital signs can be seen as reflective of many system-related factors which hamper or facilitate comprehensive care.What are the implications of these findings for clinical practice and/or further research? This study helps increase general understanding of the factors leading to progression from severe disease to death in a high-volume low-income setting.

Implementation of a first-trimester prognostic model to improve screening for gestational diabetes mellitus.

BACKGROUND: Improvement in the accuracy of identifying women who are at risk to develop gestational diabetes mellitus (GDM) is warranted, since timely diagnosis and treatment improves the outcomes of this common pregnancy disorder. Although prognostic models for GDM are externally validated and outperform current risk factor based selective approaches, there is little known about the impact of such models in day-to-day obstetric care. METHODS: A prognostic model was implemented as a directive clinical prediction rule, classifying women as low- or high-risk for GDM, with subsequent distinctive care pathways including selective midpregnancy testing for GDM in high-risk women in a prospective multicenter birth cohort comprising 1073 pregnant women without pre-existing diabetes and 60 obstetric healthcare professionals included in nine independent midwifery practices and three hospitals in the Netherlands (effectiveness-implementation hybrid type 2 study). Model performance (c-statistic) and implementation outcomes (acceptability, adoption, appropriateness, feasibility, fidelity, penetration, sustainability) were evaluated after 6 months by indicators and implementation instruments (NoMAD; MIDI). RESULTS: The adherence to the prognostic model (c-statistic 0.85 (95%CI 0.81-0.90)) was 95% (n = 1021). Healthcare professionals scored 3.7 (IQR 3.3-4.0) on implementation instruments on a 5-point Likert scale. Important facilitators were knowledge, willingness and confidence to use the model, client cooperation and opportunities for reconfiguration. Identified barriers mostly related to operational and organizational issues. Regardless of risk-status, pregnant women appreciated first-trimester information on GDM risk-status and lifestyle advice to achieve risk reduction, respectively 89% (n = 556) and 90% (n = 564)). CONCLUSIONS: The prognostic model was successfully implemented and well received by healthcare professionals and pregnant women. Prognostic models should be recommended for adoption in guidelines.

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.

Temporizing management vs immediate delivery in early-onset severe preeclampsia between 28 and 34 weeks of gestation (TOTEM study): An open-label randomized controlled trial.

INTRODUCTION: There is little evidence to guide the timing of delivery of women with early-onset severe preeclampsia. We hypothesize that immediate delivery is not inferior for neonatal outcome but reduces maternal complications compared with temporizing management. MATERIAL AND METHODS: This Dutch multicenter open-label randomized clinical trial investigated non-inferiority for neonatal outcome of temporizing management as compared with immediate delivery (TOTEM NTR 2986) in women between 27+5 and 33+5 weeks of gestation admitted for early-onset severe preeclampsia with or without HELLP syndrome. In participants allocated to receive immediate delivery, either induction of labor or cesarean section was initiated at least 48 hours after admission. Primary outcomes were adverse perinatal outcome, defined as a composite of severe respiratory distress syndrome, bronchopulmonary dysplasia, culture proven sepsis, intraventricular hemorrhage grade 3 or worse, periventricular leukomalacia grade 2 or worse, necrotizing enterocolitis stage 2 or worse, and perinatal death. Major maternal complications were secondary outcomes. It was estimated 1130 women needed to be enrolled. Analysis was by intention-to-treat. RESULTS: The trial was halted after 35 months because of slow recruitment. Between February 2011 and December 2013, a total of 56 women were randomized to immediate delivery (n = 26) or temporizing management (n = 30). Median gestational age at randomization was 30 weeks. Median prolongation of pregnancy was 2 days (interquartile range 1-3 days) in the temporizing management group. Mean birthweight was 1435 g after immediate delivery vs 1294 g after temporizing management (P = .14). The adverse perinatal outcome rate was 55% in the immediate delivery group vs 52% in the temporizing management group (relative risk 1.06; 95% confidence interval 0.67-1.70). In both groups there was one neonatal death and no maternal deaths. In the temporizing treatment group, one woman experienced pulmonary edema and one placental abruption. Analyses of only the singleton pregnancies did not result in other outcomes. CONCLUSIONS: Early termination of the trial precluded any conclusions for the main outcomes. We observed that temporizing management resulted in a modest prolongation of pregnancy without changes in perinatal and maternal outcome. Conducting a randomized study for this important research question did not prove feasible.

Women of reproductive age in a tertiary intensive care unit: indications, outcome and the impact of pregnancy-a retrospective cohort study.

BACKGROUND: To evaluate the indications for admission and mortality rates of women of reproductive age admitted to a tertiary Intensive Care Unit (ICU) and to compare the outcomes of obstetric and non-obstetric admissions. METHODS: A retrospective cohort study was performed, including all women aged 17-41 years admitted to a level 3 ICU in the Netherlands, between January 1, 2000 and January 1, 2016. Primary outcome was indication for admission and mortality. Mortality, length of stay (LOS), need for mechanical ventilation and APACHE II score were compared between obstetric and non-obstetric admissions. The obstetric group was further analyzed for maternal and perinatal outcomes. RESULTS: 3461 women (median age 32 years) were included, with an overall mortality rate of 13.3%. The obstetric group consisted of 265 women (7.7%). The non-obstetric group (n = 3196) was admitted most often for cardiovascular disease (19.6%), followed by oncologic disease (15%). Mortality was the highest in women with oncologic disease (23.9%). The obstetric group had lower mortality compared to the non-obstetric group (4.9% vs. 14%, p < 0.001), despite higher APACHE II score (14 vs. 11, p < 0.001) and a higher ventilation rate (47.9% vs. 39%, p = 0.004). Major surgical or endovascular interventions, besides caesarean section, were performed in 46% of the obstetric group. Perinatal death occurred in 17.2% and of the surviving infants, 63.2% were born preterm and 45.1% required Neonatal Intensive Care Unit admission. CONCLUSIONS: Cardiovascular disease is the most important indication for admission and oncologic disease is associated with highest mortality in women of reproductive age. Obstetric patients constitute a small percentage of all ICU admissions in a tertiary ICU center. They have lower mortality rates than non-obstetric young female patients, despite a more severe initial presentation. Nevertheless lasting maternal morbidity and perinatal mortality and morbidity is frequent.

Prevalence and determinants of chronic kidney disease in women with hypertensive disorders in pregnancy in Nigeria: a cohort study.

BACKGROUND: Worldwide, hypertensive disorders in pregnancy (HDPs) complicate between 5 and 10% of pregnancies. Sub-Saharan Africa (SSA) is disproportionately affected by a high burden of HDPs and chronic kidney disease (CKD). Despite mounting evidence associating HDPs with the development of CKD, data from SSA are scarce. METHODS: Women with HDPs (n = 410) and normotensive women (n = 78) were recruited at delivery and prospectively followed-up at 9 weeks, 6 months and 1 year postpartum. Serum creatinine was measured at all time points and the estimated glomerular filtration rates (eGFR) using CKD-Epidemiology equation determined. CKD was defined as decreased eGFR< 60 mL/min/1.73m2 lasting for ≥ 3 months. Prevalence of CKD at 6 months and 1 year after delivery was estimated. Logistic regression analyses were conducted to evaluate risk factors for CKD at 6 months and 1 year postpartum. RESULTS: Within 24 h of delivery, 9 weeks, and 6 months postpartum, women with HDPs were more likely to have a decreased eGFR compared to normotensive women (12, 5.7, 4.3% versus 0, 2 and 2.4%, respectively). The prevalence of CKD in HDPs at 6 months and 1 year postpartum was 6.1 and 7.6%, respectively, as opposed to zero prevalence in the normotensive women for the corresponding periods. Proportions of decreased eGFR varied with HDP sub-types and intervening postpartum time since delivery, with pre-eclampsia/eclampsia showing higher prevalence than chronic and gestational hypertension. Only maternal age was independently shown to be a risk factor for decreased eGFR at 6 months postpartum (aOR = 1.18/year; 95%CI 1.04-1.34). CONCLUSION: Prior HDP was associated with risk of future CKD, with prior HDPs being more likely to experience evidence of CKD over periods of postpartum follow-up. Routine screening of women following HDP-complicated pregnancies should be part of a postpartum monitoring program to identify women at higher risk. Future research should report on both the eGFR and total urinary albumin excretion to enable detection of women at risk of future deterioration of renal function.