STUDY QUESTION Does administration of recombinant human granulocyte colony stimulating factor (rhG-CSF) in the first trimester improve pregnancy outcomes, among women with a history of unexplained recurrent pregnancy loss? SUMMARY ANSWER rhG-CSF administered in the first trimester of pregnancy did not improve outcomes among women with a history of unexplained recurrent pregnancy loss. WHAT IS KNOWN ALREADY The only previous randomized controlled study of granulocyte colony stimulating factor in recurrent miscarriage in 68 women with unexplained primary recurrent miscarriage found a statistically significant reduction in miscarriage and improvement in live birth rates. A further four observational studies where G-CSF was used in a recurrent miscarriage population were identified in the literature, two of which confirmed statistically significant increase in clinical pregnancy and live birth rates. STUDY DESIGN, SIZE, DURATION A randomized, double-blind, placebo controlled clinical trial involving 150 women with a history of unexplained recurrent pregnancy loss was conducted at 21 sites with established recurrent miscarriage clinics in the United Kingdom between 23 June 2014 and 05 June 2016. The study was coordinated by University of Birmingham, UK. PARTICIPANTS/MATERIALS, SETTING, METHODS One hundred and fifty women with a history of unexplained recurrent pregnancy loss: 76 were randomized to rhG-CSF and 74 to placebo. Daily subcutaneous injections of recombinant human granulocyte – colony stimulating factor 130 μg or identical appearing placebo from as early as three to five weeks of gestation for a maximum of 9 weeks. The trial used central randomization with allocation concealment. The primary outcome was clinical pregnancy at 20 weeks of gestation, as demonstrated by an ultrasound scan. Secondary outcomes included miscarriages, livebirth, adverse events, stillbirth, neonatal birth weight, changes in clinical laboratory variables following study drug exposure, major congenital anomalies, preterm births and incidence of anti-drug antibody formation. Analysis was by intention to treat. MAIN RESULTS AND THE ROLE OF CHANCE A total of 340 participants were screened for eligibility of which 150 women were randomized. 76 women (median age, 32[IQR, 29–34] years; mean BMI, 26.3[SD, 4.2]) and 74 women (median age, 31[IQR, 26–33] years; mean BMI, 25.8[SD, 4.2]) were randomized to placebo. All women were followed-up to primary outcome, and beyond to live birth. The clinical pregnancy rate at 20 weeks, as well as the live birth rate, was 59.2% (45/76) in the rhG-CSF group, and 64.9% (48/74) in the placebo group, giving a relative risk of 0.9 (95% CI: 0.7–1.2; P = 0.48). There was no evidence of a significant difference between the groups for any of the secondary outcomes. Adverse events (AEs) occurred in 52 (68.4%) par...
The standardized mortality rate of rhabdomyolysis (RM) in Active Duty U.S. Army Soldiers is considerably higher than in the civilian population. RM occurs when large amounts of intracellular contents from damaged skeletal muscle escape into circulation, leading to serious sequelae (e.g., acute renal failure, hyperkalemia, compartment syndrome). Extended physical exertion, especially in hot environments, and trauma can precipitate RM. The aim of this study was to identify RM risk factors among U.S. Active Duty Army (ADA) Soldiers. Methods: This nested case-control study used data from the Total Army Injury and Health Outcomes Database (years 2004Database (years -2006 to examine RM among ADA male Soldiers. Demographic and occupational variables were identified as potential risk factors. Each RM case was age and date-matched to 4 controls. Adjusted odds ratios (OR) were computed using conditional logistic regression analyses. (2) self-reported Black race, OR 2.56 (95% CI 2.2-3.0); and (3) length of service (0-90 days), OR 2.05 (95% CI 1.6-2.7). Conclusion: There is a substantially greater likelihood for male U.S. Army Soldiers to develop RM who: (1) have had a prior heat injury, (2) self-report in the Black racial category, and (3) who are within the initial 90 days of service. Greater awareness of the risk factors associated with RM may improve force health protection and readiness through targeted mitigation strategies.
Like other congregate living settings, military basic training has been subject to outbreaks of COVID-19. We sought to identify improved strategies for preventing outbreaks in this setting using an agent-based model of a hypothetical cohort of trainees on a U.S. Army post. Our analysis revealed unique aspects of basic training that require customized approaches to outbreak prevention, which draws attention to the possibility that customized approaches may be necessary in other settings, too. In particular, we showed that introductions by trainers and support staff may be a major vulnerability, given that those individuals remain at risk of community exposure throughout the training period. We also found that increased testing of trainees upon arrival could actually increase the risk of outbreaks, given the potential for false-positive test results to lead to susceptible individuals becoming infected in group isolation and seeding outbreaks in training units upon release. Until an effective transmission-blocking vaccine is adopted at high coverage by individuals involved with basic training, need will persist for non-pharmaceutical interventions to prevent outbreaks in military basic training. Ongoing uncertainties about virus variants and breakthrough infections necessitate continued vigilance in this setting, even as vaccination coverage increases.Significance StatementCOVID-19 has presented enormous disruptions to society. Militaries are not immune to these disruptions, with outbreaks in those settings posing threats to national security. We present a simulation model of COVID-19 outbreaks in a U.S. Army basic training setting to inform improved approaches to prevention there. Counterintuitively, we found that outbreak risk is driven more by virus introductions from trainers than the large number of trainees, and that outbreak risk is highly sensitive to false-positive results during entry testing. These findings suggest practical ways to improve prevention of COVID-19 outbreaks in basic training and, as a result, maintain the flow of new soldiers into the military. This work highlights the need for bespoke modeling to inform prevention in diverse institutional settings.
Background Laboratory screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a key mitigation measure to avoid the spread of infection among recruits starting basic combat training in a congregate setting. Since viral nucleic acid can be detected persistently after recovery, we evaluated other laboratory markers to distinguish recruits who could proceed with training from those who were infected. Methods Recruits isolated for coronavirus disease 2019 (COVID-19) were serially tested for SARS-CoV-2 subgenomic ribonucleic acid (sgRNA), and viral load (VL) by reverse transcriptase polymerase chain reaction (RT-PCR), and for anti- SARS-CoV-2. Cluster and quadratic discriminant analyses of results were performed. Results Among 229 recruits isolated for COVID-19, those with a RT-PCR cycle threshold >30.49 (sensitivity 95%, specificity 96%) or having sgRNA log10 RNA copies/mL <3.09 (sensitivity and specificity 96%) at entry into isolation were likely SARS-CoV-2 uninfected. Viral load > 4.58 log10 RNA copies/mL or anti- SARS-CoV-2 signal-to-cutoff ratio < 1.38 (VL: sensitivity and specificity 93%; anti- SARS-CoV-2: sensitivity 83%, specificity 79%) had comparatively lower sensitivity and specificity when used alone for discrimination of infected from uninfected. Conclusions Orthogonal laboratory assays used in combination with RT-PCR may have utility in determining SARS-CoV-2 infection status for decisions regarding isolation.
Background Significant variability exists in the application of infection control policy throughout the United States (U.S.) Army initial entry training environment. To generate actionable information for the prevention of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)/coronavirus disease 2019 (COVID-19) transmission among new recruits, active enhanced surveillance was conducted for evidence of and exposure to SARS-CoV-2/COVID-19. Methods We serially tested recruits with a reverse transcriptase polymerase chain reaction (RT-PCR) COVID-19 and/or total antibody to SARS-CoV-2 tests at day 0, 14, and week 10 upon arrival for basic combat training at a location in the southern U.S. Results Among 1,403 recruits who were enrolled over a 6 week period from August 25 through October 11, 2020, 84 recruits tested positive by RT-PCR with more than half (55%, 46/84) testing positive at arrival and almost two-thirds (63%, 53/84) also testing seropositive at arrival. Similarly, among an overall 146 recruits who tested seropositive for SARS-CoV-2 during the period of observation, a majority (86%) of tested seropositive at arrival; no hospitalizations were observed among seropositive recruits and antibody response increased at week 10. Conclusions These findings suggest serological testing may complement current test-based measures and provide another tool to incorporate in COVID-19 mitigation measures among trainees in the U.S. Army.
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