Positive predictive values for detection of trisomies 21, 18 and 13 and termination of pregnancy rates after referral for advanced maternal age, first trimester combined test or ultrasound abnormalities in a national screening programme (2007-2009)

Objective: The objective of this article is to analyse the positive predictive value (PPV) of trisomies 21, 18 and 13 after referral for advanced maternal age (AMA), first trimester combined test or ultrasound findings to suggest improvements for clinical practice. Methods: Data (48457 combined tests, 134000 fetal anomaly scans and 24379 invasive prenatal tests) were combined to calculate PPV and termination of pregnancy rates. Results: For referral for AMA, the PPV for T21 was 1.0% and 1.8% for amniocentesis and chorionic villus biopsy, respectively; for the combined test at a maternal age ≥36years, these percentages were 4.9% and 12.5%, respectively and for maternal age 90% unless detected after referral for ultrasound findings (71.5-85.9%). About 50% of pregnant women with a high combined test risk chose not to have invasive testing. Conclusions: Advanced MA is still a large contributor to invasive testing but should be abandoned (low PPV, high fetal loss rate) and be replaced by reimbursable combined test screening for all women. Patient information on second trimester ultrasound screening should indicate that abnormal ultrasound findings are associated with high trisomy rate

Home-Based Monitoring and Telemonitoring of Complicated Pregnancies: Nationwide Cross-Sectional Survey of Current Practice in the Netherlands

Background: Daily monitoring of fetal and maternal conditions in complicated pregnancies leads to recurrent outpatient visits or (prolonged) hospitalization. Alternatives for hospital admissions include home-based monitoring with home visits by professionals or telemonitoring with self-measurements performed by pregnant women and uploaded for in-clinic assessment. For both alternatives, cardiotocography and blood pressure measurement can be performed at home. It is unknown to what extent, for which reasons, and for which pregnancy complications these strategies are used. Objective: This study aims to assess the current practice and attitudes concerning home-based monitoring (with daily home visits by professionals) and telemonitoring (using devices and the internet for daily self-recorded measurements) in high-risk pregnancies requiring maternal and fetal monitoring in the Netherlands. Methods: This nationwide cross-sectional study involved sending a web-based survey to the obstetrics departments of all 73 hospitals in the Netherlands to be answered by 1 representative dedicated to pregnancy monitoring per hospital. The primary outcome was the provision of home-based monitoring or telemonitoring using cardiotocography between 1995 and 2018. The survey further addressed perspectives regarding the use of home-based monitoring and telemonitoring, including (contra)indications, advantages, and disadvantages for pregnant women and clinicians. Results: The response rate for the provision of either home-based monitoring or telemonitoring was 100%. In 2018, 38% (28/73) of centers in the Netherl

Implementation of a standard outcome set in perinatal care: a qualitative analysis of barriers and facilitators from all stakeholder perspectives

Background: To improve their quality, healthcare systems are increasingly focused on value delivered to patients. For perinatal care, the International Consortium for Health Outcomes Measurement (ICHOM) proposed a patient-centred outcome set with both clinical and patient-reported measures for pregnancy and childbirth (PCB set). This study aimed to identify factors that affect the implementation of the PCB set at the pre-implementation stage, using the consolidated framework for implementation research (CFIR). Methods: In this qualitative study, we conducted semi-structured interviews amongst a purposive sample of key stakeholders within an obste

A feasibility study of implementing a patient-centered outcome set for pregnancy and childbirth

Background and Aims: Patient-reported outcome and experience measures (PROM and PREM) can facilitate shared decision making and hold potential to improve healthcare quality. However, their adoption in perinatal care is still limited. The International Consortium for Health Outcomes Measurement (ICHOM) developed a Pregnancy and Childbirth (PCB) outcome set, including PROM and PREM questionnaires. We studied the feasibility to use these PROMs/PREMs in Dutch perinatal care, addressing both women's and professionals' perspective. Methods: Patients and professionals in primary and hospital care participated. Women under care at one of five timepoints for PROM/PREM collection of the PCB set (2 during pregnancy, 3 postpartum) were e-mailed a questionnaire and discussed their answers with their obstetric professional the next regular visit. Compliance was recorded. After discussing the PROMs/PREMs, usability and experience were assessed with separate surveys amongst women and professionals. Results: Of 26 women approached, 21 completed and discussed their PROM/PREM questionnaire. Mean questionnaire completion rate was 97%. Average reported time completing the questionnaires was 10 minutes; most women (90%) stated this was acceptable. Women preferred completing questionnaires digitally and discuss their answers with an obstetric professional rather than othe

Prognostic models versus single risk factor approach in first-trimester selective screening for gestational diabetes mellitus: a prospective population-based multicentre cohort study

Objectives: To evaluate whether (1) first-trimester prognostic models for gestational diabetes mellitus (GDM) outperform the currently used single risk factor approach, and (2) a first-trimester random venous glucose measurement improves model performance. Design: Prospective population-based multicentre cohort. Setting: Thirty-one independent midwifery practices and six hospitals in the Netherlands. Population: Women recruited before 14 weeks of gestation without pre-existing diabetes. Methods: The single risk factor approach (presence of at least one risk factor: BMI ≥30 kg/m2, previous macrosomia, history of GDM, positive first-degree family history of diabetes, non-western ethnicity) was compared with the four best performing models in our previously published external validation study (Gabbay-Benziv 2014, Nanda 2011, Teede 2011, van Leeuwen 2010) with and without the addition of glucose. Main outcome measures: Discrimination was assessed by c-statistics, calibration by calibration plots, added value of glucose by the likelihood ratio chi-square test, net benefit by decision curve analysis and reclassification by reclassification plots. Results: Of the 3723 women included, a total of 181 (4.9%) developed GDM. The c-statistics of the prognostic models were higher, ranging from 0.74 to 0.78 without glucose and from 0.78 to 0.80 with glucose, compared with

SAFE@HOME: Digital health platform facilitating a new care path for women at increased risk of preeclampsia – A case-control study

Objective: In women at risk of developing preeclampsia, we evaluated the use of a digital health platform for telemonitoring blood pressure and symptoms combined with a minimal antenatal visit schedule. Study design: A case-control study for women with chronic hypertension, history of preeclampsia, or maternal cardiac or kidney disease. A care path was designed with reduced visits enhanced with a digital platform (SAFE@HOME) for daily blood pressure and symptom monitoring starting from 16 weeks of gestation. Homemeasurements were monitored in-hospital by obstetric professionals, taking actions upon alarming results. This prospective SAFE@HOME group was compared to a retrospective control group managed without self-monitoring. Main outcome measures: Primary: healthcare consumption (number of antenatal visits, ultrasounds, admissions and diagnostics), user experiences of the platform. Secondary: mate

Current practice of first-trimester ultrasound screening for structural fetal anomalies in developed countries

Objectives: First-trimester ultrasound screening is increasingly performed to detect fetal anomalies early in pregnancy, aiming to enhance reproductive autonomy for future parents. This study aims to display the current practice of first-trimester ultrasound screening in developed countries. Method: An online survey among 47 prenatal screening experts in developed countries. Results: First-trimester structural anomaly screening is available in 30 of the 33 countries and is mostly offered to all women with generally high uptakes. National protocols are available in 23/30 (76.7%) countries, but the extent of anatomy assessment varies. Monitoring of scan quality occurs in 43.3% of the countries. 23/43 (53.5%) of the respondents considered the quality of first-trimester ultrasound screening unequal in different regions of their country. Conclusions: First-trimester screening for structural fetal anomalies is widely offered in developed countries, but large differences are reported in availability and use of screening protocols, the extent of anatomy assessment, training and experience of sonographers and quality monitoring systems. Consequently, this results in an unequal offer to parents in developed countries, sometimes even within the same country. Furthermore, as offer and execution differ widely, this has to be taken into account when results of screening policies are scientifically published or compared.</p

Nationwide implementation of a decision aid on vaginal birth after cesarean:a before and after cohort study

Woman with a history of a previous cesarean section (CS) can choose between an elective repeat CS (ERCS) and a trial of labor (TOL), which can end in a vaginal birth after cesarean (VBAC) or an unplanned CS. Guidelines describe women's rights to make an informed decision between an ERCS or a TOL. However, the rates of TOL and vaginal birth after CS varies greatly between and within countries. The objective of this study is to asses nation-wide implementation of counselling with a decision aid (DA) including a prediction model, on intended delivery compared to care as usual. We hypothesize that this may result in a reduction in practice variation without an increase in cesarean rates or complications. In a multicenter controlled before and after cohort study we evaluate the effect of nation-wide implementation of a DA. Practice variation was defined as the standard deviation (SD) of TOL percentages. A total of 27 hospitals and 1,364 women were included. A significant decrease was found in practice variation (SD TOL rates: 0.17 control group vs. 0.10 intervention group following decision aid implementation, p=0.011). There was no significant difference in the ERCS rate or overall CS rates. A 21% reduction in the combined maternal and perinatal adverse outcomes was seen. Nationwide implementation of the DA showed a significant reduction in practice variation without an increase in the rate of cesarean section or complications, suggesting an improvement in equality of care

Effectiveness of a cervical pessary for women who did not deliver 48 h after threatened preterm labor (Assessment of perinatal outcome after specific treatment in early labor: Apostel VI trial)

Background: Preterm birth is a major cause of neonatal mortality and morbidity. As preventive strategies are largely ineffective, threatened preterm labor is a frequent problem that affects approximately 10 % of pregnancies. In recent years, risk assessment in these women has incorporated cervical length measurement and fetal fibronectin testing, and this has improved the capacity to identify women at increased risk for delivery within 14 days. Despite these improvements, risk for preterm birth continues to be increased in women who did not deliver after an episode of threatened preterm labor, as indicated by a preterm birth rate between 30 to 60 % in this group of women. Currently no effective treatment is available. Studies on maintenance tocolysis and progesterone have shown ambiguous results. The pessary has not been evaluated in women with threatened preterm labor, however studies in asymptomatic women with a short cervix show reduced rates of preterm birth rates as well as perinatal complications. The APOSTEL VI trial aims to assess the effectiveness of a cervical pessary in women who did not deliver within 48 h after an episode of threatened preterm labor. Methods/Design: This is a nationwide multicenter open-label randomized clinical trial. Women with a singleton or twin gestation with intact membranes, who were admitted for threatened preterm labor, at a gestational age between 24 and 34 weeks, a cervical length between 15 and 30 mm and a positive fibronectin test or a cervical length below 15 mm, who did not deliver after 48 h will be eligible for inclusion. Women will be allocated to a pessary or no intervention (usual care). Primary outcome is preterm delivery <37 weeks. Secondary outcomes are amongst others a composite of perinatal morbidity and mortality. Sample size is based on an expected 50 % reduction of preterm birth before 37 weeks (two-sided test, a 0.05 and beta 0.2). Two hundred women with a singleton pregnancy need to be randomized. Analysis will be done by intention to treat. Discussion: The APOSTEL VI trial will provide evidence whether a pessary is effective in preventing preterm birth in women who did not deliver 48 h after admission for threatened pretermlabor and who remain at high risk for preterm birth