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Objectives To perform a nationwide study of quadrichorionic quadriamniotic (QCQA) quadruplet pregnancies and to compare the pregnancy outcome in those undergoing fetal reduction with non-reduced quadruplets and dichorionic diamniotic (DCDA) twin pregnancies from the same time period. Methods This was a retrospective Danish national register-based study performed using data from the national Danish Fetal Medicine Database, which included all QCQA quadruplets and all non-reduced DCDA twin pregnancies with an estimated due date between 2008 and 2018. The primary outcome measure was a composite of adverse pregnancy outcomes, including pregnancy loss or intrauterine death of one or more fetuses. Secondary outcomes included gestational age at delivery, the number of liveborn children, preterm delivery before 28, 32 and 37 gestational weeks and birth weight. Data on pregnancy complications and baseline characteristics were also recorded. Outcomes were compared between reduced and non-reduced quadruplet pregnancies, and between DCDA pregnancies and quadruplet pregnancies reduced to twins. A systematic literature search was performed to describe and compare previous results with our findings. Results Included in the study were 33 QCQA quadruplet pregnancies, including three (9.1%) non-reduced pregnancies, 28 (84.8%) that were reduced to twin pregnancy and fewer than three (6.1%) that were reduced to singleton pregnancy, as well as 9563 DCDA twin pregnancies. Overall, the rate of adverse pregnancy outcome was highest in non-reduced quadruplets (66.7%); it was 50% in quadruplets reduced to singletons and 10.7% in quadruplets reduced to twins. The proportion of liveborn infants overall was 91.1% of the total number expected to be liveborn in quadruplet pregnancies reduced to twins. This was statistically significantly different from 97.6% in non-reduced dichorionic twins (P = 0.004), and considerably higher than 58.3% in non-reduced quadruplets. Th, Objectives: To perform a nationwide study of quadrichorionic quadriamniotic (QCQA) quadruplet pregnancies and to compare the pregnancy outcome in those undergoing fetal reduction with non-reduced quadruplets and dichorionic diamniotic (DCDA) twin pregnancies from the same time period. Methods: This was a retrospective Danish national register-based study performed using data from the national Danish Fetal Medicine Database, which included all QCQA quadruplets and all non-reduced DCDA twin pregnancies with an estimated due date between 2008 and 2018. The primary outcome measure was a composite of adverse pregnancy outcomes, including pregnancy loss or intrauterine death of one or more fetuses. Secondary outcomes included gestational age at delivery, the number of liveborn children, preterm delivery before 28, 32 and 37 gestational weeks and birth weight. Data on pregnancy complications and baseline characteristics were also recorded. Outcomes were compared between reduced and non-reduced quadruplet pregnancies, and between DCDA pregnancies and quadruplet pregnancies reduced to twins. A systematic literature search was performed to describe and compare previous results with our findings. Results: Included in the study were 33 QCQA quadruplet pregnancies, including three (9.1%) non-reduced pregnancies, 28 (84.8%) that were reduced to twin pregnancy and fewer than three (6.1%) that were reduced to singleton pregnancy, as well as 9563 DCDA twin pregnancies. Overall, the rate of adverse pregnancy outcome was highest in non-reduced quadruplets (66.7%); it was 50% in quadruplets reduced to singletons and 10.7% in quadruplets reduced to twins. The proportion of liveborn infants overall was 91.1% of the total number expected to be liveborn in quadruplet pregnancies reduced to twins. This was statistically significantly different from 97.6% in non-reduced dichorionic twins (P = 0.004), and considerably higher than 58.3% in non-reduced quadruplets. The rates of preterm deliv

AIM: To evaluate a conservative estimate of the prevalence of chromosome conditions in all fetuses and children with a major congenital heart defect (CHD) in Denmark between 2008 and 2018.METHODS: This was a national register-based study including all singleton pregnancies with a pre- or postnatally diagnosed major CHD usually requiring surgery within the first year of life and a due date between July 2008 and December 2018 in Denmark. Data were retrieved from the Danish Fetal Medicine Database (DFMD) and the Danish Cytogenetic Central Register (DCCR) in the fall of 2020. The DCCR contains information on all prenatal and postnatal genetic analyses including karyotyping, chromosomal microarray, polymerase chain reaction, multiplex ligation-dependent probe amplification, and fluorescence in situ hybridization. All cases were reviewed by a clinical geneticist, and genetic changes were classified as pathogenic, likely pathogenic, uncertain significance, likely benign, and benign. Pathogenic and likely pathogenic were considered to be abnormal. Cases with a CHD without any registered chromosome analysis reported were considered genetically normal. Isolated CHD was defined as a case with a major CHD without any other structural malformations detected pre- or postnatally. Results were given as total numbers and frequencies. Comparison between isolated and non-isolated cases was performed using logistic regression analysis and presented as odds ratios (ORs) including 95% confidence intervals (CI).RESULTS: We retrieved 8,482 cases with any cardiovascular diagnosis from the DFMD and excluded twins (n=112) and minor CHD (n=6,921), resulting in 1,449 cases with major CHD. Of the included cases, 917 (63.3%) had a chromosome analysis performed with an abnormal test result in 186 cases, resulting in a prevalence of chromosomal conditions of 12.8% (95% confidence interval 11.2;14.7) in cases with major CHD. The highest prevalences were found in cases with pulmonary

OBJECTIVE: To investigate the prevalence and national prenatal detection rate (DR) of major CHD (mCHD) in twin pregnancies without twin-to-twin transfusion syndrome (TTTS)-associated CHD in a population following a universal, standardized prenatal screening program.METHODS: All Danish twin pregnancies are offered standardized screening and surveillance programs besides the 1st and 2nd -trimester screening for aneuploidies and malformation, respectively: Monochorionic twins every two weeks from gestational week 15, and dichorionic twins every four weeks from week 18. The study was performed retrospectively with prospectively collected data. The data were retrieved from the Danish Fetal Medicine Database and included all twin pregnancies from 2009-2018, where at least one fetus had a mCHD diagnosis pre- and/or postnatally. A mCHD was defined as a CHD requiring surgery within the first year of life, excluding ventricular septal defects. All pregnancies were pre- and postnatally validated in the local patient files at the four tertiary centers covering the entire country.RESULTS: A total of 60 cases from 59 pregnancies were included. The prevalence of mCHD in twins was 4.6 per 1,000 twin pregnancies (95% confidence interval (CI) 3.5-6.0) (1.9 per 1,000 liveborn children (95% CI 1.3-2.5)). The prevalence for DC and MC were 3.6 (95% CI 2.6-5.0) and 9.2 (95% CI 5.8-13.7) per 1,000 pregnancies, respectively. The national DR of mCHD in twin pregnancies for the entire period was 68.3%. The highest detections were in cases with univentricular hearts (100%) and the lowest with a total anomaly of the pulmonary venous return, Ebstein's anomaly, aortic valve stenosis, and coarctation of the aorta (0-25%). Mothers of children with undetected mCHD had a significantly higher BMI compared to mothers of children with a detected mCHD (median 27 and 23, respectively, p=0.03).CONCLUSIONS: The prevalence of mCHD in twins was 4.6 per 1,000 pregnancies, and more frequ

Item does not contain fulltext, Older people are often affected by impaired organ and bodily functions resulting in multimorbidity and polypharmacy, turning them into the main user group of many medicines. Very often, medicines have not specifically been developed for older people, causing practical medication problems for them like limited availability of easy to swallow formulations, easy to open packaging and dosing instructions for enteral administration. In 2020, the European Medicines Agency (EMA) published a reflection paper 'Pharmaceutical development of medicines for use in the older population', which discusses how the emerging needs of an ageing European population can be addressed by medicines regulation. The paper intends to help industry to better consider the needs of older people during pharmaceutical/clinical medicines development by summarising data on the most relevant topics, providing early suggestions on how to move forward and prompting expert discussions and studies into knowledge gaps. Topics include patient acceptability, (dis)advantages of an administration route, formulation, dosage form, packaging, dosing device and user instruction. While the paper is directed at older people and the pharmaceutical industry, the reflections are also relevant to younger patients with similar disease-related needs and of value to other stakeholders parties, e.g., healthcare professionals, academics, patients and caregivers, as the paper makes clear what can be expected from industry and where collaborative work is needed. This commentary provides an overview of the different steps in the development of the reflection paper, discusses points considered most controversial and/or subject to (multidisciplinary) expert discussions and indicates their value for real world clinical practice.

Objective: To investigate prenatal changes in cardiac biometric and flow parameters in fetuses with bicuspid aortic valve (BAV) diagnosed neonatally compared with controls with normal cardiac anatomy. Methods: This analysis was conducted as part of the Copenhagen Baby Heart Study, a multicenter cohort study of 25 556 neonates that underwent second-trimester anomaly scan at 18 + 0 to 22 + 6 weeks' gestation and neonatal echocardiography within 4 weeks after birth, in Copenhagen University Hospital Herlev, Hvidovre Hospital and Rigshospitalet in greater Copenhagen, between April 2016 and October 2018. From February 2017 (Rigshospitalet) and September 2017 (Herlev and Hvidovre hospitals), the protocol for second-trimester screening of the heart was extended to include evaluation of the four-chamber view, with assessment of flow across the atrioventricular valves, sagittal view of the aortic arch and midumbilical artery and ductus venosus pulsatility indices. All images were evaluated by two investigators, and cardiac biometric and flow parameters were measured and compared between cases with BAV and controls. All cases with neonatal BAV were assessed by a specialist. Maternal characteristics and first- and second-trimester biomarkers were also compared between the two groups. Results: Fifty-five infants with BAV and 8316 controls with normal cardiac anatomy were identified during the study period and assessed using the extended prenatal cardiac imaging protocol. There were three times as many mothers who smoked before pregnancy in the group with BAV as in the control group (9.1% vs 2.7%; P = 0.003). All other baseline characteristics were similar between the two groups. Fetuses with BAV, compared with controls, had a significantly larger diameter of the aorta at the level of the aortic valve (3.1 mm vs 3.0 mm (mean difference, 0.12 mm (95% CI, 0.03–0.21 mm))) and the pulmonary artery at the level of the pulmonary valve (4.1 mm vs 3.9 mm (mean difference, 0.15 mm (95

In a recent publication in this journal, Drukker et al.1 reviewed the role of Artificial Intelligence (AI) in ultrasound imaging in Obstetrics and Gynecology. The authors describe the application of AI algorithms for automated detection and classification of standard planes, among other applications. One particular challenge is that large amounts of ultrasound images are required to train these AI algorithms. The way the resulting algorithms are trained carries a risk of introducing bias. Secondly, a potential problem arises in the application of algorithms outside the context of the population of data on which the algorithms were trained and validated. There is currently insufficient evidence that AI algorithms generalize from the population they are trained on to other populations. It is problematic for the general adoption of research results if AI algorithms fail to generalise across different settings. We here describe how an AI algorithm developed in a British setting and using data from a British population in 2016 performs with images obtained in a Danish population across two fetal medicine centers between 2009 and 2017.

OBJECTIVE: To evaluate the risk of inducing RhD immunisation in pregnancies of RhD-negative mothers with an RhD-positive fetus undergoing chorionic villus samplings (CVS) or amniocenteses (AC).DESIGN, SETTING AND POPULATION: Registry-based study in a Danish cohort which has not been given rhesus prophylaxis.METHODS: Data were retrieved from the Department of Clinical Immunology at Rigshospitalet. All RhD-negative women carrying an RhD-positive fetus with screen test results from weeks 8-12 and weeks 25-29 were linked to data from the Danish Fetal Medicine Database. Data were divided into cases where no invasive prenatal diagnostic procedure was performed, cases that had AC performed, and cases that had CVS performed.MAIN OUTCOME MEASURES: A comparison of the proportion of women who developed RhD immunisation between the two screen tests.RESULTS: The cohort consisted of 10 085 women: 9353 had no invasive procedures performed, 189 had AC and 543 had CVS performed. No women were immunised spontaneously or due to the procedure between the first and second screen test in the group with no procedure performed, or in the AC group. One woman was immunised in the CVS group. When comparing the proportion of women who was immunised in the CVS group with the no invasive test group a non-significant difference was found (P = 0.055).CONCLUSION: The RhD immunisation rate before gestational weeks 25-29 in RhD-negative women carrying an RhD-positive fetus is very low, even in women undergoing prenatal invasive testing without rhesus prophylaxis.TWEETABLE ABSTRACT: The RhD immunisation rate during pregnancy is very low even in women undergoing prenatal invasive testing.

Background Employing apps in assessment of symptoms during cancer treatment facilitates detection of adverse events and may improve patient outcomes. Our interactive app Interaktor supports patients’ symptom management by regular symptom reporting, alerts for rapid access to staff in case of severe symptoms and continual access to relevant self-care advice. The aim of this study was to describe usage and explore perceptions of using Interaktor during cancer treatment. Methods The study includes the participants from the intervention arms of two separate randomized controlled trials (RCT) on patients with breast cancer (n = 74) during neoadjuvant chemotherapy and locally advanced prostate cancer (n = 75) during radiotherapy. It comprises usage metrics analysed by descriptive statistics and interviews analyzed by conventional content analysis. Results Adherence to daily reporting during treatment was in median above 80 %. Most patients viewed the information pages with self-care advice numerous times. The app was perceived user-friendly, faciliating interaction with health care professionals and supporting self care. Symptom reporting was a quick and comfortable way to access help. Using the app generated feelings of being monitored, involved and cared for. Further it supported attentiveness to and reflection of own well- being but could also serve as a reminder of illness. Some patients described that vigor, comorbidity, and cognitive side effects from the treatment influenced the motivation for and ability to symptom report. The information pages with self care advice were useful and appreciated and gave an idea of what was to be expected during treatment. Patients requested added and more comprehensive information on psychological symptoms and dietary advice. Conclusions The Interaktor app is a userfriendly and convenient alternative for patients contact and involvement with health care that aided symptom management, self-care and further enhanced patients particip

Background: Several chemical UV filters/absorbers ('UV filters' hereafter) have endocrine-disrupting properties in vitro and in vivo. Exposure to these chemicals, especially during prenatal development, is of concern. Objectives: To examine maternal exposure to UV filters, associations with maternal thyroid hormone, with growth factor concentrations as well as to birth outcomes. Methods: Prospective study of 183 pregnant women with 2nd trimester serum and urine samples available. Maternal concentrations of the chemical UV filters benzophenone-1 (BP-1) and benzophenone-3 (BP-3) in urine and 4-hydroxy-benzophenone (4-HBP) in serum were measured by liquid chromatography–tandem mass spectrometry (LC–MS/MS). The relationships between 2nd trimester maternal concentrations of the three chemical UV filters and maternal serum concentrations of thyroid hormones and growth factors, as well as birth outcomes (weight, height, and head and abdominal circumferences) were examined. Results: Positive associations between maternal serum concentrations of 4-HBP and triiodothyronine (T3), thyroxine (T4), insulin-like growth factor I (IGF-I) and its binding protein IGFBP3 were observed in mothers carrying male fetuses. Male infants of mothers in the middle 4-HBP exposure group had statistically significantly lower weight and shorter head and abdominal circumferences at birth compared to the low exposure group. Conclusions: Widespread exposure of pregnant women to chemical UV filters and the possible impact on maternal thyroid hormones and growth factors, and on fetal growth, calls for further studies on possible long-term consequences of the exposure to UV filters on fetal development and children’s health.

BACKGROUND: Previous studies have demonstrated widespread exposure of humans to certain benzophenones commonly used as UV filters or UV absorbers; some of which have been demonstrated to have endocrine disrupting abilities.OBJECTIVES: To examine whether benzophenones present in pregnant women pass through the placental barrier to amniotic fluid and further to the fetal blood circulation.METHODS: A prospective study of 200 pregnant women with simultaneously collected paired samples of amniotic fluid and maternal serum and urine. In addition, unique samples of human fetal blood (n=4) obtained during cordocentesis: and cord blood (n=23) obtained at delivery, both with paired maternal samples of serum and urine collected simultaneously, were used. All biological samples were analyzed by TurboFlow-liquid chromatography - tandem mass spectrometry for seven different benzophenones.RESULTS: Benzophenone-1 (BP-1), benzophenone-3 (BP-3), 4-methyl-benzophenone (4-MBP), and 4-hydroxy-benzophenone (4-HBP) were all detectable in amniotic fluid and cord blood samples and except 4-HBP also in fetal blood; albeit at a low frequency. BP-1 and BP-3 were measured at ~10-times lower concentrations in fetal and cord blood compared to maternal serum and 1000-times lower concentration compared to maternal urine levels. Therefore BP-1 and BP-3 were only detectable in the fetal circulation in cases of high maternal exposure indicating some protection by the placental barrier. 4-MBP seems to pass into fetal and cord blood more freely with a median 1:3 ratio between cord blood and maternal serum levels. Only for BP-3, which the women seemed to be most exposed to, did the measured concentrations in maternal urine and serum correlate to concentrations measured in amniotic fluid. Thus, for BP-3, but not for the other tested benzophenones, maternal urinary levels seem to be a valid proxy for fetal exposure.CONCLUSIONS: Detectable levels of several of the investigated