Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.SEQUOIA (ClinicalTrials.gov identifier: NCT03336333) is a phase III, randomized, open-label trial that compared the oral Bruton tyrosine kinase inhibitor zanubrutinib to bendamustine plus rituximab (BR) in treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The initial prespecified analysis (median follow-up, 26.2 months) and subsequent analysis (43.7 months) found superior progression-free survival (PFS; the primary end point) in patients who received zanubrutinib compared with BR. At a median follow-up of 61.2 months, median PFS was not reached in zanubrutinib-treated patients; median PFS was 44.1 months in BR-treated patients (hazard ratio [HR], 0.29; one-sided P = .0001). Prolonged PFS was seen with zanubrutinib versus BR in patients with mutated immunoglobulin heavy-chain variable region (IGHV) genes (HR, 0.40; one-sided P = .0003) and unmutated IGHV genes (HR, 0.21 [95% CI, 0.14 to 0.33]; one-sided P < .0001). Median overall survival (OS) was not reached in either treatment arm; estimated 60-month OS rates were 85.8% and 85.0% in zanubrutinib- and BR-treated patients, respectively. No new safety signals were detected. Adverse events were as expected with zanubrutinib; rate of atrial fibrillation was 7.1%. At a median follow-up of 61.2 months, the results supported the initial SEQUOIA findings and suggested that zanubrutinib was a favorable treatment option for untreated patients with CLL/SLL.

• MeSH
• Bendamustine Hydrochloride * administration & dosage   therapeutic use   MeSH
• Leukemia, Lymphocytic, Chronic, B-Cell * drug therapy   mortality   MeSH
• Progression-Free Survival MeSH
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Follow-Up Studies MeSH
• Piperidines therapeutic use   administration & dosage   adverse effects   MeSH
• Antineoplastic Combined Chemotherapy Protocols * therapeutic use   adverse effects   MeSH
• Pyrazoles * therapeutic use   administration & dosage   adverse effects   MeSH
• Pyrimidines * therapeutic use   administration & dosage   adverse effects   MeSH
• Rituximab * administration & dosage   therapeutic use   adverse effects   MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial, Phase III MeSH
• Multicenter Study MeSH
• Randomized Controlled Trial MeSH
• Comparative Study MeSH

Since 2017, targeted therapies combined with conventional intensive chemotherapy have started to improve outcomes of patients with acute myeloid leukemia (AML). However, even before these innovations, outcomes with intensive chemotherapy had improved, which has not yet been extensively studied. Thus, we used a large pan-European multicenter dataset of the HARMONY Alliance to evaluate treatment-time dependent outcomes over two decades. In 5,359 AML patients, we compared the impact of intensive induction therapy on outcome over four consecutive 5-year calendar periods from 1997 to 2016. During that time, the 5-year survival of AML patients improved significantly, also across different genetic risk groups. In particular, the 60-day mortality rate dropped from 13.0% to 4.7% over time. The independent effect of calendar periods on outcome was confirmed in multivariate models. Improvements were documented both for patients <60 and ≥60 years old, and in those treated with and without consolidating allogeneic hematopoietic stem cell transplantation (alloHCT). While survival of AML elderly patients remains poor, patients ≥60 years old overall have a 20% survival benefit at 5 years if they receive an alloHCT. While further outcome improvement in intensively treated AML patients will likely be driven by targeted treatment approaches, this pan-European HARMONY dataset can serve as a multicenter comparator for future studies.

• MeSH
• Leukemia, Myeloid, Acute * mortality   therapy   diagnosis   epidemiology   MeSH
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Prognosis MeSH
• Antineoplastic Combined Chemotherapy Protocols * therapeutic use   MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Hematopoietic Stem Cell Transplantation MeSH
• Treatment Outcome MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Geographicals
• Europe MeSH

Although sodium-glucose cotransporter 2 inhibitors reduce the risk of cardiovascular death or worsening heart failure (HF) in patients with chronic HF, there are limited data on initiation in hospitalized patients with HF. DAPA ACT HF-TIMI 68 (Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure - Thrombolysis in Myocardial Infarction 68) is an international, randomized, double-blind trial evaluating the initiation of dapagliflozin (10 mg daily) vs placebo in 2,401 patients hospitalized for acute HF. Patients were enrolled irrespective of left ventricular ejection fraction, type 2 diabetes status, or chronicity of HF (de novo and worsening chronic HF). Randomized participants receive blinded treatment for 2 months. The primary efficacy endpoint is time to first occurrence of cardiovascular death or worsening HF (worsening HF during the index admission, rehospitalization for worsening HF, or urgent HF visit). Key safety endpoints include symptomatic hypotension and worsening kidney function. This is the first cardiovascular outcomes trial designed specifically to evaluate the efficacy and safety of in-hospital initiation of dapagliflozin in patients hospitalized for the management of acute HF. (Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure - Thrombolysis in Myocardial Infarction 68 [DAPA ACT HF-TIMI 68]; NCT04363697; EudraCT # 2022-001262-35).

• MeSH
• Acute Disease MeSH
• Benzhydryl Compounds * therapeutic use   administration & dosage   MeSH
• Diabetes Mellitus, Type 2 complications   drug therapy   MeSH
• Double-Blind Method MeSH
• Sodium-Glucose Transporter 2 Inhibitors * therapeutic use   MeSH
• Glucosides * therapeutic use   administration & dosage   MeSH
• Hospitalization MeSH
• Middle Aged MeSH
• Humans MeSH
• Multicenter Studies as Topic MeSH
• Randomized Controlled Trials as Topic MeSH
• Aged MeSH
• Heart Failure * drug therapy   physiopathology   MeSH
• Stroke Volume MeSH
• Treatment Outcome MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial Protocol MeSH

Úvod: Dlouhodobé užívání metforminu může vést vedle zažívacích potíží, ke vzniku laktátové acidózy, zhoršení renálních funkcí i k deficitu vitaminu B12 (VB12). Cílem naší práce bylo poukázat na rizikovost dlouhodobého užití metforminu zejména ve vyšších dávkách na konkrétním souboru námi léčených diabetiků 2. typu. Pacienti a metodika: V roce 2024 bylo celkem v diabetologické ambulanci Diastop, s. r. o., (NZZ – nestátní zdravotnické zařízení) dlouhodobě léčeno 2 136 diabetiků 2. typu (T2DM), a to 1 111 mužů a 1 025 žen. Jejich věk byl 72,7 ± 12,5 roků. Z nich 70 % bylo ≥ 65 roků a 12,6 % ≥ 80 roků. Z nich bylo v roce 2024 pouze diabetickou dietou léčeno 12 % (věku 74,5 ± 10,6 roků). Preparáty PAD, inkretinovými mimetiky nebo inzulinem v roce 2024 bylo léčeno celkem 1 880 diabetiků 2. typu (88 %) průměrného věku 72,3 ± 10,7 roků. Šlo o retrospektivní studii. Výsledky: Sledovanými parametry byly věk, trvání diabetu, hodnocení polyneuropatie, základní biochemické a hematologické vyšetření (krevní obraz), VB12, folát a homocystein (u nemocných s metforminem). Metforminem bylo dlouhodobě léčeno (ve studii nejméně posledních 6 měsíců) 522 osob – 250 žen a 272 mužů věku 68,8 ± 10,4 roků. Z nich 24 % bylo ≥ 65 roků a 5 % ≥ 80 roků. Výrazný pokles hladiny VB12 pod 148 pmol/l jsme nalezli 81krát (15,5 %); hraniční výsledek v pásmu 148–221 pmol/l u 157 jedinců (30,1 %). Závěr: Naše sdělení ve shodě s literaturou na souboru našich pacientů poukazuje na riziko rozvoje deficitu VB12 ve vztahu k denní dávce metforminu. Podobně i věk by měl vždy být brán v úvahu jako další potencionálně rizikový faktor s respektováním všech kontraindikací a možných lékových interakcí. U diabetiků s deficitem VB12 jsme nenalezli závažné klinické projevy (anémie atp.).

Introduction: Long-term use of metformin can lead to digestive problems, lactic acidosis, and deterioration of renal function, as well as vitamin B12 deficiency. The aim of our work was to point out the risk of long-term use of metformin, especially in higher doses, in a specific group of patients with type 2 diabetes treated by us. Patients and methodology: In 2024, a total of 2,136 patients with type 2 diabetes (T2DM) were treated in the diabetes outpatient clinic Diastop, l. t. d. (non-state healthcare facility) a long time - 1,111 men and 1,025 women. Of these, 70 % were ≥ 65 years old and 12.6 % were ≥ 80 years old. Their age was 72.7 ± 12.5 years. Of these, 12 % (age 74.5 ± 10.6 years) were treated with a diabetic diet alone in 2024. A total of 1,880 patients with T2DM (88 %) with an average age of 72.3 ± 10.7 years were treated with OAD preparations, incretin mimetics or insulin in 2024. It was a retrospective study. Results: The monitored parameters were age, duration of diabetes, assessment of polyneuropathy, basic biochemical and hematological examination (blood count), VB12, folate and homocysteine (in patients with metformin). Metformin was treated long-term (in the study for at least the last 6 months) by 522 people - 250 women and 272 men aged 68.8 ± 10.4 years. Of these, 24 % were ≥ 65 years old and 5 % were ≥ 80 years old. A significant decrease in VB12 levels below 148 pmol/l was found in 81 cases (15.5 %); a borderline result in the range of 148-221 pmol/l in 157 individuals (30.1 %). Conclusion: Our report, in agreement with the literature, on our patient population points to the risk of developing VB12 deficiency in relation to the daily dose of metformin. Similarly, age should always be taken into account as another potential risk factor, respecting all contraindications and possible drug interactions. We did not find any serious clinical manifestations (anemia, etc.) in T2DM patients with VB12 deficiency.

• MeSH
• Diabetes Mellitus, Type 2 drug therapy   MeSH
• Middle Aged MeSH
• Humans MeSH
• Metformin * administration & dosage   adverse effects   MeSH
• Vitamin B 12 Deficiency * chemically induced   MeSH
• Retrospective Studies MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Clinical Study MeSH

Periférne artériové obliterujúce ochorenie (PAOO) sa vyskytuje u diabetikov minimálne 3-krát častejšie ako v nediabetickej populácii a často vedie k invalidizujúcim komplikáciám, ako je amputácia dolnej končatiny. Doteraz bolo vykonaných relatívne málo štúdií zacielených na túto vysoko rizikovú skupinu pacientov. V štúdii STRIDE bolo zaradených 972 diabetikov 2. typu s PAOO štádia Fontaine IIa. Bol testovaný efekt prídavnej liečby semaglutidom v porovnaní s placebom. Primárnym výsledkom bola maximálna prejdená vzdialenosť na bežiacom páse. Pacienti užívajúci semaglutid mali túto vzdialenosť o 13 % väčšiu ako jedinci, ktorí dostávali placebo. Efekt semaglutidu bol veľmi podobný doteraz najviac odporúčanému cilostazolu v tejto indikácii. Na rozdiel od cilostazolu semaglutid v predchádzajúcich štúdiách mal dokázané pozitívne efekty na zníženie kardiovaskulárnej morbidity a mortality, a teda sa javí ako liek prvej voľby na liečbu pacientov s PAOO v klaudikačnom štádiu.

Peripheral artery disease (PAD) occurs at least three times more frequently in patients with diabetes than in the non-diabetic population and often leads to disabling complications such as lower limb amputation. To date, relatively few studies have targeted this high-risk group of patients. The STRIDE study included 972 patients with type 2 diabetes in Fontaine IIa stage of PAD. The effect of add-on treatment with semaglutide was tested in comparison to placebo. The primary outcome was the maximum walking distance on a treadmill. Patients using semaglutide had a 13 % greater walking distance than those receiving placebo. The effect of semaglutide was very similar to cilostazol, which is currently the most recommended treatment for this indication. Unlike cilostazol, semaglutide has demonstrated positive effects in previous studies on reducing cardiovascular morbidity and mortality, and therefore appears to be the most suitable first-line drug for treating patients with claudicant-stage PAOD.

• Keywords
• semaglutid,
• MeSH
• Glucagon-Like Peptide-1 Receptor Agonists * pharmacology   therapeutic use   MeSH
• Diabetes Mellitus, Type 2 * drug therapy   complications   MeSH
• Humans MeSH
• Peripheral Arterial Disease * drug therapy   MeSH
• Randomized Controlled Trials as Topic MeSH
• Check Tag
• Humans MeSH
• Publication type
• Research Support, Non-U.S. Gov't MeSH
• Review MeSH

Meta-analyses of observational and clinical studies conducted in recent years have raised serious doubts about the validity of the low-fat dietary recommendations introduced in the late 1970s/early 1980s, due to the absence of any convincing link between saturated fat and the risk of cardiovascular diseases. At the same time, long-term food supply statistics from the FAOSTAT database show that these recommendations were at the root of fundamental dietary changes in Western countries, which resulted in a lower consumption of eggs and red meat, a higher consumption of cereals and poultry, a decline in average protein quality and, overall, in a higher glycemic load of the diet. Because current views on human nutrition are based primarily on highly unreliable questionnaire data from observational studies, the purpose of this commentary is to provide an alternative ecological (country-level) perspective and to trace the consequences of these nutritional changes using the FAOSTAT database in combination with available anthropological and health statistics. This comparison shows a close connection between the decline in protein quality and the sudden reversal of the positive height trend in some Western countries, after ∼150 years of continuous growth, which points to suboptimal levels of child nutrition. The sharp increase in the prevalence of obesity and type 2 diabetes is strongly correlated with the increasing consumption of high-glycemic carbohydrates and sweeteners, and is also interconnected with the decrease in body height, because a high-quality, growth-stimulating diet during adolescence is inversely related to obesity. Given the long-term association between height and phenotypic IQ, the lower quality of nutrients in children's diet may also seriously affect intellectual potential and future civilizational development. In light of these findings, current nutritional strategies should be seriously reconsidered and recommended protein intakes for children must be urgently reevaluated.

• MeSH
• Diabetes Mellitus, Type 2 epidemiology   MeSH
• Diet * trends   MeSH
• Child MeSH
• Humans MeSH
• Adolescent MeSH
• Obesity * epidemiology   MeSH
• Body Height * MeSH
• Food Supply * statistics & numerical data   MeSH
• Check Tag
• Child MeSH
• Humans MeSH
• Adolescent MeSH
• Publication type
• Journal Article MeSH

BACKGROUND: Type 2 diabetes and prediabetes represent significant global health challenges, with physical activity (PA) being essential for disease management and prevention. Despite the well-documented benefits, many individuals with (pre)diabetes remain insufficiently active. General practitioners (GP) provide an accessible platform for delivering interventions; however, integrating PA interventions into routine care is hindered by resource constraints. OBJECTIVES: The ENERGISED trial aims to address these barriers through an innovative GP-initiated mHealth intervention combining wearable technology and just-in-time adaptive interventions. METHODS: The ENERGISED trial is a pragmatic, 12-month, multicentre, randomised controlled trial, assessing a GP-initiated mHealth intervention to increase PA and reduce sedentary behaviour in patients with type 2 diabetes and prediabetes. The primary outcome is daily step count, assessed via wrist-worn accelerometry. The primary analysis follows the intention-to-treat principle, using mixed models for repeated measures. Missing data will be handled under the missing-at-random assumption, with sensitivity analyses exploring robustness through reference-based multiple imputation. The trial incorporates the estimand framework to provide transparent and structured treatment effect estimation. DISCUSSION: This statistical analysis plan outlines a robust approach to addressing participant non-adherence, protocol violations, and missing data. By adopting the estimand framework and pre-specified sensitivity analyses, the plan ensures methodological rigour while enhancing the interpretability and applicability of results. CONCLUSIONS: The ENERGISED trial leverages innovative mHealth strategies within primary care to promote PA in individuals with (pre)diabetes. The pre-specified statistical framework provides a comprehensive guide for analysing trial data and contributes to advancing best practices in behavioural intervention trials for public health. TRIAL REGISTRATION: ClinicalTrials.gov NCT05351359 . Registered on April 28, 2022.

• MeSH
• Accelerometry MeSH
• Exercise * MeSH
• Diabetes Mellitus, Type 2 * therapy   psychology   diagnosis   MeSH
• Fitness Trackers MeSH
• Humans MeSH
• Multicenter Studies as Topic MeSH
• Wearable Electronic Devices MeSH
• Pragmatic Clinical Trials as Topic MeSH
• General Practice * methods   MeSH
• Prediabetic State * therapy   psychology   diagnosis   MeSH
• Sedentary Behavior * MeSH
• Telemedicine * statistics & numerical data   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial Protocol MeSH

BACKGROUND: Minimally invasive surgery may be further advanced with the novel biofragmentable magnetic anastomosis compression system. Two magnets may be swallowed, or placed by flexible endoscopy, in a side-to-side magnetic jejuno-ileostomy (MagJI) bipartition for weight and type 2 diabetes (T2D) reduction. MagJI markedly reduces the major complications of enterotomy, stapling/suturing, and retained foreign materials. METHODS: This was a prospective first-in-human investigation of feasibility, safety, and preliminary efficacy in adults with body mass index (BMI, kg/m2) ≥ 30.0- ≤ 40.0. After serial introduction via swallowing or endoscopy, linear magnets were laparoscopically guided to the distal ileum and proximal jejunum where they were aligned. Magnets fused over 7-21 days forming jejuno-ileostomy. PRIMARY ENDPOINTS: feasibility and severe adverse event (SAEs) incidence (Clavien-Dindo grade); secondary endpoints: weight, T2D reduction. RESULTS: Between 3-1 - 2024 and 6-30 - 2024, nine patients (mean BMI 37.3 ± 1.1) with T2D (all on T2D medications; mean HbA1C 7.1 ± 0.2%, glucose 144.8 ± 14.3 mg/dL) underwent MagJI. Mean procedure time: both magnets swallowed, 86.7 ± 6.3 min; one magnet swallowed with second delivered endoscopically, 113.3 ± 17.0 min. Ninety-day feasibility confirmed in 100.0%: 0.0% bleeding, leakage, infection, mortality. Most AEs grade I-II; no SAEs. At 6-month radiologic confirmation, all anastomoses were patent. Excess weight loss 17.5 ± 2.8 kg; mean BMI reduction 2.2 ± 0.3, HbA1C 6.1 ± 0.1% (p < 0.01), glucose 115.5 ± 6.5 mg/dL (p = 0.19); 83.0% dropped below 6.5% HbA1C and had markedly reduced anti-T2D medications. CONCLUSIONS: The swallowable, biofragmentable magnetic anastomosis system appeared to be feasible and safe in achieving incisionless, sutureless jejuno-ileostomy. The first-in-human MagJI procedure may offer minimally complicated anastomosis creation and moderate MBS weight loss and T2D reduction.

• MeSH
• Anastomosis, Surgical methods   MeSH
• Diabetes Mellitus, Type 2 * surgery   MeSH
• Adult MeSH
• Weight Loss MeSH
• Ileum * surgery   MeSH
• Body Mass Index MeSH
• Jejunostomy * methods   instrumentation   MeSH
• Jejunum * surgery   MeSH
• Laparoscopy methods   MeSH
• Middle Aged MeSH
• Humans MeSH
• Magnetics MeSH
• Magnets * MeSH
• Prospective Studies MeSH
• Feasibility Studies MeSH
• Treatment Outcome MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

Cíl: Těhotenství se nepovažuje za stav zvyšující náchylnost organismu k infekci SARS-CoV-2 (severe-acute-respiratory-syndrome-related coronavirus 2), avšak v případě nákazy v graviditě se zvyšuje riziko závažnějšího průběhu nemoci covid-19. Ve většině případů ovšem bývá průběh infekce v graviditě mírný nebo bezpříznakový. Hlavním cílem studie u těhotných žen s covidem-19 (coronavirové onemocnění) bylo dokázat, že způsob porodu se nemění a závažné komplikace jak porodnické, tak neonatologické se kvůli tomuto onemocnění nevyskytují častěji. Metody: Do retrospektivní, observační, multicentrické studie byly zařazeny pacientky s pozitivním testem na covid-19, které byly přijaty a následně porodily v období od 15. března 2020 do 15. března 2021. Data z porodnických oddělení pěti center v České republice během pandemie covidu-19 byla analyzována ve vztahu k metodě a době porodu, symptomům covidu-19 a potenciálním komplikacím s ohledem na demografii a komorbidity těhotných žen. Infekce koronavirem byla u pacientek potvrzena pomocí PCR (polymerázové řetězové reakce). Statistická analýza byla hodnocena pomocí programu Excel. Výsledky: Během sledovaného období bylo ve studijních centrech detekováno 236 těhotných žen s covidem-19. Většina pacientek byla asymptomatická (59,7 %). U symptomatických pacientek byly nejčastějšími příznaky kašel (52,6 %), nachlazení (43,2 %) a horečka (37,9 %) a covidová pneumonie byla diagnostikována u 8 pacientek. Porod byl proveden vaginálně u 52,5 % pacientek, těhotenství bylo ukončeno císařským řezem v 44,5 %, per VEX (vakuumextrakce) v 2,1 % a per forcipem v 0,8 % případů. Průměrný týden gravidity v době porodu byl 38 a předčasný porod byl proveden u 19,1 % pacientek. Výsledky tyto studie u těhotných žen s covidem-19 prokázaly, že způsob porodu se nezměnil a výskyt větších komplikací jak porodnických, tak neonatologických nebyl ve většině případů zaznamenán. Dva prezentované závažné průběhy covidu-19 u těhotných žen však vedly k předčasnému ukončení těhotenství. Jediným přidruženým rizikovým faktorem byla obezita pacientky. Závěry: Ačkoli je covid-19 onemocnění, které je u těhotných žen většinou asymptomatické nebo má pouze mírné příznaky podobné chřipce, je spojeno se zvýšenou nemocností a úmrtností ve srovnání s těhotnými ženami bez covidu-19. Výzvou do budoucna je možnost segregace pacientek do nízko a vysoce rizikových skupin na základě prokázaných rizikových faktorů a důsledné očkování těhotných žen nebo žen plánujících početí. V kritických případech je nutné správné načasování předčasného ukončení těhotenství a včasná indikace počátku zrání plic plodu.

Objective: Pregnancy is not considered a condition that increases the body‘s susceptibility to SARS-CoV-2 (severe-acute-respiratory-syndrome-related coronavirus-2) infection, but in the case of infection in pregnancy, there is an increased risk of a more severe course of COVID-19 (coronavirus disease-19). However, the course of infection in pregnancy is mild or asymptomatic in most cases. The main objective of the study in pregnant women with COVID-19 was to prove that the delivery method is not changed, and serious complications do not occur more frequently due to this disease. Methods: In a retrospective, observational, multicentric study, the pregnant women positively tested to COVID-19 were admitted and subsequently gave birth in the period from 15 March 2020 to 15 March 2021. Data from the delivery departments of five centers in the Czech Republic during COVID-19 pandemic were analyzed in relation to the delivery method and time, COVID-19 symptoms and potential complications with respect to demographics and comorbidities of pregnant women. COVID-19 positivity was confirmed with PCR (polymerase-chain reaction). The Excel program was used during statistical analysis. Results: During the observed study period, 236 pregnant women with COVID-19 were detected at study centers. Most of the patients were asymptomatic (59.7%). In symptomatic patients, most common symptoms were cough (52.6 %), cold (43.2%) and fever (37.9%), and COVID-19 pneumonia was diagnosed in 8 patients. The delivery was performed vaginally in 52.5% patients, the pregnancy was terminated by C-section (cesarean section) in 44.5%, per VEX (vacuum extractor) in 2.1% and per forcipem in 0.8% cases. The average week of pregnancy at the time of delivery was 38 (29–41) and preterm delivery was performed in 19.1% patients. The study results in pregnant women with COVID-19 demonstrated that the method of delivery was not changed and major delivery and neonatological complications did not develop in most cases. However, two presented serious courses of COVID-19 in pregnant women led to premature terminations of pregnancies. The only associated risk factor was the patient‘s obesity. Conclusions: Although COVID-19 is a disease that is mostly asymptomatic in pregnant women or with only mild flu-like symptoms, it is associated with increased morbidity and mortality compared to pregnant women without COVID-19. The challenge for the future is the possibility of segregating patients into lowand high-risk groups based on proven risk factors, and consistent vaccination of pregnant women or women planning conception. In critical cases, the correct timing of premature termination of pregnancy and early indication of the beginning of fetal lung maturation is necessary.

• MeSH
• COVID-19 * complications   mortality   MeSH
• Diagnostic Imaging methods   MeSH
• Obstetric Labor Complications * microbiology   MeSH
• Pregnancy Complications * microbiology   MeSH
• Humans MeSH
• Retrospective Studies MeSH
• Risk Factors MeSH
• Check Tag
• Humans MeSH
• Geographicals
• Czech Republic MeSH

OBJECTIVE: Early hypoglycaemia at the time of neonatal intensive care unit (NICU) admission is common in very/extreme preterm infants. This study aimed to determine whether buccal dextrose gel in the delivery room (DR) would improve rates of early hypoglycaemia in this population. DESIGN: Randomised, blinded, placebo-controlled trial. SETTING: Four level-3 and one level-2 neonatal units. PATIENTS: Inborn infants≤32+0 weeks gestational age (GA). INTERVENTIONS: Infants were randomised to 40% dextrose or placebo gel in the DR (≤29+0 GA: 0.5 mL gel, ≥29+1 GA: 1 mL gel). MAIN OUTCOME MEASURE: Hypoglycaemia (<1.8 mmol/L) measured at the time of first intravenous access at NICU admission. RESULTS: Between November 2020 and August 2022, the recruitment rate was slow (impacted by the requirement for antenatal consent). This fact, coupled with finite research resources, led to a decision to end recruitment early. Data analysis of 169 newborns (33% of target sample size) showed no significant difference in the frequency of the primary outcome between dextrose 24/84 (29%) and placebo 25/85 (29%) groups (OR 0.95; 95% CI 0.49 to 1.86; p=0.88). A post-hoc analysis indicated that the trial had a low (47% conditional power) chance of detecting a statistically significant benefit from the intervention (had the target sample been achieved). CONCLUSIONS: This study showed no evidence of benefit of 40% dextrose gel on rates of hypoglycaemia at NICU admission. Management of these vulnerable newborns should continue to focus on vascular access and commencement of dextrose-containing intravenous fluids as early as possible. TRIAL REGISTRATION NUMBER: NCT04353713.

• MeSH
• Administration, Buccal MeSH
• Gels MeSH
• Gestational Age MeSH
• Glucose * administration & dosage   MeSH
• Hypoglycemia * drug therapy   prevention & control   MeSH
• Intensive Care Units, Neonatal MeSH
• Blood Glucose analysis   MeSH
• Humans MeSH
• Infant, Premature, Diseases * drug therapy   MeSH
• Infant, Premature MeSH
• Infant, Newborn MeSH
• Delivery Rooms MeSH
• Sweetening Agents administration & dosage   MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Infant, Newborn MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Randomized Controlled Trial MeSH