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Fetal Heart Tracing

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201. Assessment of the concordance among 2-tier, 3-tier, and 5-tier fetal heart rate classification systems. (Abstract)

Assessment of the concordance among 2-tier, 3-tier, and 5-tier fetal heart rate classification systems. In 2008, a National Institute of Child Health and Human Development/Society for Maternal-Fetal Medicine-sponsored workshop on electronic fetal monitoring recommended a new fetal heart tracing interpretation system. Comparison of this 3-tier system with other systems is lacking. Our purpose was to determine the relationships between fetal heart rate categories for the 3 existing systems.Three (...) Maternal-Fetal Medicine specialists reviewed 120 fetal heart rates. All tracings were from term, singleton pregnancies with known umbilical artery pH. The fetal heart rates were classified by a 2-tier, 3-tier, and 5-tier system.Each Maternal-Fetal Medicine examiner reviewed 120 fetal heart rate segments. When compared with the 2-tier system, 0%, 54%, and 100% tracings in categories 1, 2, and 3 were "nonreassuring." There was strong concordance between category 1 and "green" as well as category 3

2011 American Journal of Obstetrics and Gynecology

202. Interobserver and intraobserver reliability of the NICHD 3-Tier Fetal Heart Rate Interpretation System. (Abstract)

Interobserver and intraobserver reliability of the NICHD 3-Tier Fetal Heart Rate Interpretation System. Our purpose was to test the reliability of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 3-Tier Fetal Heart Rate (FHR) classification system.Individual 15- to 20-minute FHR segments (n = 154) were independently reviewed without clinical data by 3 maternal-fetal medicine examiners and classified by NICHD category (I, II, III).Interobserver (...) reliability was moderate (kappa 0.45) and varied by NICHD category (category I moderate [kappa 0.48], category II moderate [kappa 0.44], and category III poor [kappa 0.0]). The intraobserver agreement ranged from substantial to perfect (kappa 0.74-1.0).Interobserver agreement of 3-Tier FHR classification System was moderate for NICHD categories I and II. Agreement for category III tracings was poor mainly due to lack of agreement regarding absent vs minimal variability.Copyright © 2011 Mosby, Inc. All

2011 American Journal of Obstetrics and Gynecology

203. Intrapartum care for healthy women and babies

, she will need to be transferred to obstetric-led care. [2017] [2017] 1.4.9 Offer continuous cardiotocography if any of the risk factors listed in recommendation 1.4.3 are identified on initial assessment, and explain to the woman why this is being offered. (See also section 1.10 on fetal monitoring.) [2017] [2017] 1.4.10 Offer cardiotocography if intermittent auscultation indicates possible fetal heart rate abnormalities, and explain to the woman why this is being offered. If the trace is normal (...) tr ansferred (% of total transferred from each ansferred from each setting) setting) F From home rom home (n=3,529) (n=3,529) F From a freestanding rom a freestanding midwifery unit (n=2,457) midwifery unit (n=2,457) F From an alongside rom an alongside midwifery unit midwifery unit (n=4,401) (n=4,401) Delay during first or second stage of labour 1,144 (32.4%) 912 (37.1%) 1,548 (35.2%) Abnormal fetal heart rate 246 (7.0%) 259 (10.5%) 477 (10.8%) Request for regional analgesia 180 (5.1%) 163 (6.6

2014 National Institute for Health and Clinical Excellence - Clinical Guidelines

204. Standards for obstetrical ultrasound assessments

/ absence of yolk sac or embryo ? ? Fetal number: ? ? if multiple – chorionicity and amnionicity ? ? Location of gestational sac ? ? Cardiac activity: ? ? Presence / absence ? ? Fetal Heart Rate (FHR) ? ? Crown rump length (CRL) ? ? Maternal pelvic anatomy (adnexa, ovaries, cervix) ? ? Head circumference (HC) ? ? Biparietal diameter (BPD) ? ? Choroid plexus filled ventricles ? ? Stomach ? ? Symmetrical lung fields ? ? Presence of 4 limbs, each with 3 segments ? ? Abdominal wall cord insertion ? ? NT (...) measurement in mm to 1 decimal point ? ? FMF# of person performing the NT measurement ? ? Standard comments established by the BC Prenatal Genetic Screening Program (PGSP)? Appendix 5 4.0 Minimum Required Content, cont’d8 Perinatal Services BC 4.3 2nd Trimester Ultrasound Report (14wks 1d – 26wks 6d) Must include the items listed in “ALL OB Ultrasound Reports” in addition to the following: ? ? Cardiac activity: ? ? Presence / absence ? ? Fetal Heart Rate (FHR) ? ? Cardiac axis ? ? Fetal number

2016 CPG Infobase

205. Joint NASPGHAN and ESPGHAN guidelines on Gastro-oesophageal Reflux Disease in Children

Renal Lead poisoning Obstructive uropathy Other toxins Renal insuf?ciency Cardiac Heart failure Vascular ring Autonomic dysfunction ESPGHAN ¼ European Society for Pediatric Gastroenterology, Hepatology, and Nutrition; GERD ¼ gastroesophageal re?ux disease; NASPGHAN ¼ North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. Adapted from the ESPGHAN/NASPGHAN 2009 GERD guidelines. JPGN Volume 66, Number 3, March 2018 Pediatric Gastroesophageal Reflux Clinical Practice (...) for esophageal disorders included new classi?cations for adults with typical GERD symptoms including chest pain and heart burn. In patients with persistent typical symptoms despite acid suppression, pH-MII can clarify the diagnosis of NERD (pathologic re?ux regardless of symptom correlation), hyper- sensitive esophagus (positive symptom correlation with either acid or nonacid re?ux events but no pathologic re?ux), and functional heartburn (negative symptom correlation and no pathologic re?ux; see ‘‘Summary

2018 British Society of Paediatric Gastroenterology Hepatology and Nutrition

206. Zika virus and safety of substances of human origin: a guide for preparedness activities in Europe ? first update

transmission through cells, tissues and organs remains unknown. Zika virus can also be transmitted vertically from an infected mother to the foetus during pregnancy and is responsible for foetal loss, microcephaly, and other congenital neurological syndromes [9]. The incubation period ranges from 3.5 days in a human volunteer [10] to 6 to 10 days in returning travellers and blood donors [3,11,12]. Although previous reports state that 80% of Zika virus infection cases are asymptomatic [13], it seems (...) -virus associated Guillain–Barré syndrome (GBS) have not been reported. Moreover, the likelihood of maternal and foetal exposure to blood products and presumably to other SoHO is very small. Data on Zika virus infection in donors of cells, tissues and organs and transmission of the virus to the transplant recipients are lacking. Nevertheless, the clear association between Zika virus infection and congenital malformations and GBS justifies the implementation of preventive measures to reduce the risk

2017 European Centre for Disease Prevention and Control - Technical Guidance

207. Improving the health of the public by 2040

and medical interventions. However, despite overall improvements in health, major inequalities in health outcomes, reflecting social and economic inequalities, persist.1. Introduction 12 • Vaccination. • Motor vehicle safety. • Safer workplaces. • Control of infectious diseases. • Decline in deaths from coronary heart disease and stroke. • Safer and healthier foods. • Healthier mothers and babies. • Family planning. • Fluoridation of drinking water. • Recognition of tobacco use as a health hazard. Box 1 (...) and in the last 50 years has increased by a further 10 years for a man and 8 for a woman. 3,4 Improvements in living conditions and large reductions in infant and child mortality were major contributors to this increase in the first half of the 20th century. Over the last 50 years, improvement has been greatest at older ages. The number of people dying from coronary heart disease, for example, in Great Britain more than halved between 1961 and 2009. 5 While improved treatments have had an important role

2017 Academy of Medical Sciences

208. Trumenba - meningococcal group b vaccine (recombinant, adsorbed)

in the final packaging process may contain trace levels of animal tallow derivatives. As tallow is processed under rigorous conditions, it is considered compliant with the TSE note for guidance. The information provided does not give rise to any concerns on adventitious agents. The absence of adventitious agents has been sufficiently demonstrated. 2.2.4. Discussion on chemical, pharmaceutical and biological aspects The quality documentation submitted in support of Trumenba was considered of good quality

2017 European Medicines Agency - EPARs

209. Dinutuximab beta Apeiron - neuroblastoma

processing ECG Electrocardiogram ECHO Echocardiogram EEG Electroencephalogram EFS event-free survival ELISA Enzyme-linked immunosorbent assay EM(E)A European Medicines Agency EOT End of treatment EPC End of Production Cells Assessment Report - Dinutuximab beta Apeiron EMA/263814/2017 Page 5/129 ESI-TOF-MS Electrospray ionisation time-of-flight mass spectrometry FAS Full analysis set FCS Fetal calf serum Fc?R FC gamma receptor FDA Food and Drug Administration G0 Glycan without core fucose and no galactose (...) 150 kDa corresponding to the expected size of an intact IgG1, but smaller faint bands were also visible at about 100 kDa, 70kDa and 26kDa on the gels. The identity of these bands has been clarified as product-related variants of ch14.18/CHO, with only traces of HCP. Bands at 50kDa appear to contain heavy chain and two light chains, with the band at 25 kDa appearing to be mainly free light chain with low levels of HCP. Since these are all at levels well below the main band (by densitometry

2017 European Medicines Agency - EPARs

210. Zika virus and safety of substances of human origin ? A guide for preparedness activities in Europe

]. Congenital microcephaly, central nervous system malformations and other foetal malformations potentially associated with Zika virus infection during pregnancy have been reported in several countries or territories [11]. It is probable that the risk of transplacental infection and developing congenital central nervous system malformations depends on the gestational age at the time of infection and other factors. Results from ongoing and further case–control and cohort studies are still required

2016 European Centre for Disease Prevention and Control - Technical Guidance

211. Let?s talk about protection: enhancing childhood vaccination uptake public health guidance

it as easy and simple as possible. Although people don’t generally enjoy being vaccinated, removing some of the inconvenience and difficulties in getting protected will go a long way towards increasing uptake. Reframe the discussion so that the main focus is on being protected, rather than on vaccine safety Framing strategies i are at the heart of behavioural communication. The language – verbal and visual – in which an issue is expressed, and the terms in which it is presented, can determine how (...) brochures and posters. Some provide information evenings for parents or organise sessions to inform future parents when they visit midwives and obstetricians. Maintain your skills to ensure safe vaccine administration People do not perceive vaccines in the same way that they view other pharmaceutical products. Unlike medications which tend to be categorised and scrutinised in a wide variety of disease- or organ-specific categories (e.g. heart, kidney, skin, etc.), all vaccines tend to be placed

2016 European Centre for Disease Prevention and Control - Public Health Guidance

212. National minimum retesting intervals in pathology: A final report detailing consensus recommendations for minimum retesting intervals for use in pathology

Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H et al. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J 2011; 32:2999–3054. Thygesen K, Mair J, Katus H, Plebani M, Venge P, Collinson P et al. Recommendations for the use of cardiac troponin measurement in acute cardiac care. Eur Heart J 2010;31:2197– 2204. Croal BL, Hillis GS, Gibson PH, Fazal MT, El-Shafei H, Gibson G et al. The relationship between (...) Cardiac Ref Clinical situation Recommendation Source B-C1 Using troponin (general) Acute coronary syndrome (ACS) Cardiac surgery Renal failure MRI largely dependent on the assay being used and the clinical scenario. MRIs should be implemented according to the local protocol used High sensitivity troponin assays will usually require several samples – with a second sample within 3 hours of presentation, the sensitivity for Myocardial infarction approaches 100% For standard troponin assays - If the first

2016 Royal College of Pathologists

213. Ongentys (opicapone) - Parkinson?s disease

in the periphery by aromatic L-amino acid decarboxylase, also called dopa decarboxylase, to dopamine, which can cause side effects such as emesis, orthostatic hypotension, and cardiac arrhythmia. To minimise the formation of dopamine in the periphery, L-DOPA is usually administered in combination with a peripheral DDCI (benserazide or carbidopa). However, when administered together with such inhibitors, only a relatively small amount of an oral dose of L-DOPA reaches the brain because COMT becomes the major (...) have failed to identify issues for QT and cardiac repolarisation. Concerning the lack of discussion for respiratory, gastrointestinal, renal and central nervous system parameters, the applicant reviewed the toxicokinetics from the 13 week rat study (Study No: D38007) to determine exposure to metabolite, BIA 9-1103, where a dose of 1000 mg/kg of Opicapone gave a Cmax of 10.60 µg/mL and an AUC0-t of 90.90 µg•h/mL for BIA 9-1103 on Day 1. This compares to clinical exposure levels of Cmax 0.74 µg/mL

2016 European Medicines Agency - EPARs

215. Strimvelis (autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence) - evere combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID)

nervous system CPP Critical process parameters CQA Critical Quality Attributes CSR Clinical study report CUP Compassionate use program CVC Central venous catheter dATP Deoxyadenosine triphosphate dAXP Deoxyadenosine nucleotides deaminase EBMT European Group for Blood and Marrow Transplantation EPC End of Productions cells ERT Enzyme replacement therapy ESID European Society for Immunodeficiencies EU European Union FBS Foetal bovine serum FMEA Failure Mode Effect Analysis Fondazione Centro San Raffaele (...) marker gene (?NGFR) to assist with detection, quantification, and purification of transduced cells. Optimal conditions for ex vivo gene transfer and maintenance of haematopoietic progenitor cells included cytokine stem cell factors [thrombopoietin, FMS-like tyrosinekinase 3 ligand as well as interleukin (IL)-3] and supplementation of medium with 4% foetal calf serum. Cultured CD34+ cells maintained the ability to differentiate into myeloid and erythroid cells (in clonogenic assays

2016 European Medicines Agency - EPARs

216. Wakix - pitolisant. Narcolepsy

, QTcF, and QTcV intervals which occurred together with rapid and marked increases in blood pressure and heart rate. The effect of pitolisant on respiratory parameters was investigated in pentobarbital-anaesthetized rats treated i.v. at 0.5, 1, 2, 4, and 6 mg/kg. No adverse effect on measured parameters was noted at up to 4 mg/kg. At 6 mg/kg, a clear increase of the tidal volume was noted. The Irwin test showed signs of central excitation from the low dose level (3 mg/kg, p.o.), with additional (...) findings of muscular hypotony and sedation, and changes in state of mood at 30 mg/kg and above. Trace of tremors was observed at 60 mg/kg and minimal appearance of opisthotonus and few tonic and clonic convulsions at 100 mg/kg. Furthermore, pitolisant was shown to display a pro- convulsant activity at doses higher than 30 mg/kg, p.o. in the pentylenetetrazole-induced convulsion mouse model. Overall, pitolisant induced a dose-dependent increase in central excitation leading to the appearance

2016 European Medicines Agency - EPARs

217. Ixazomib (Ninlaro) - multiple myeloma

studies No secondary pharmacodynamics studies have been conducted (see discussion on non-clinical aspects). Safety pharmacology programme In vitro, ixazomib (0.00508 to 100 µM) weakly inhibited the cloned cardiac potassium (K + ) hERG channel in HEK-293 cells with a Ki of 24.9 µM and an IC50 of 59.6 µM. The ixazomib concentration (Ki of 24.9 µM) associated with in vitro hERG activity is >190-fold the human Cmax of approximately 0.13 µM at the clinical phase 3 dose of 4 mg administered QW for 3 weeks (...) on a 28-day cycle (the multiple is significantly greater when accounting for human plasma protein binding). A telemetry in vivo study was performed in beagle dogs to evaluate the effects of ixazomib on the CVS. ECG, nervous system, and respiratory evaluations were also conducted as part of GLP-compliant repeated-dose toxicology studies in rats and dogs. No treatment-related effects on blood pressure, heart rate, or ECG parameters (including PR interval, QRS duration, QT interval, and corrected QT

2016 European Medicines Agency - EPARs

220. Aspirin for prophylactic use in the primary prevention of cardiovascular disease and cancer: a systematic review and overview of reviews

[RR 0.94, 95% con?dence interval (CI) 0.88 to 1.00] and 10% reduction in major cardiovascular events (MCEs) (RR 0.90, 95% CI 0.85 to 0.96) to a reduction in total coronary heart disease (CHD) of 15% (RR 0.85, 95% CI 0.69 to 1.06). Reported pooled odds ratios (ORs) for total cancer mortality ranged between 0.76 (95% CI 0.66 to 0.88) and 0.93 (95% CI 0.84 to 1.03). Inclusion of the Women's Health Study changed the estimated OR to 0.82 (95% CI 0.69 to 0.97). Aspirin reduced reported colorectal cancer (...) of Initial Vascular Events ASA acetylsalicylic acid ASCEND A Study of Cardiovascular Events in Diabetes ASPREE Aspirin in Reducing Events in the Elderly ATT Antithrombotic Trialists BDT British Doctors Trial BP blood pressure CARING Chronotherapy with Low-dose Aspirin for Primary Prevention CHD coronary heart disease CI con?dence interval COD cause of death COX cyclo-oxygenase COX-1 cyclo-oxygenase 1 COX-2 cyclo-oxygenase 2 CRC colorectal cancer CRD Centre for Reviews and Dissemination CV cardiovascular

2013 NIHR HTA programme

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