Pregnant women with diabetes and their clinician's experience of participating in a pilot randomised controlled trial of corticosteroid administration in late pregnancy: A qualitative study.

BACKGROUND: Little research exists to support the administration of corticosteroids to pregnant women with diabetes. Pregnant women are often excluded from clinical trials due to concerns of harm to the foetus. AIM: This study aimed to understand the experiences of women and clinicians of participating in the Prevention of neonatal Respiratory distress with antenatal corticosteroids before Elective Caesarean section in women with Diabetes pilot randomised controlled trial to determine the acceptability of the study protocol. METHODS: Women and clinicians participating in the pilot trial were invited to complete a telephone interview regarding their experiences of participating. Qualitative data were collected and subsequently analysed using thematic analysis. RESULTS: A total of 13 women and nine clinicians were recruited between June 2020 and May 2022 for a telephone interview. Participating in the study was deemed acceptable by women and clinicians. Women chose to participate in the study due to the perceived low risk of harm associated with the intervention and for altruistic reasons. The high level of clinical support and information provided for the duration of the pilot trial was valued by women and clinicians. All clinicians highlighted the importance of conducting the trial to inform evidence-based practice. CONCLUSIONS: Pregnant women are more likely to participate in clinical trials when perceived risks are low and they are well-informed during decision-making. Clinicians will support clinical trials when they perceive a benefit to practice and feel assured that women receive extensive monitoring and support. Incorporating these factors into study protocols is more likely to be successful in recruiting pregnant women and maintaining the engagement of clinical staff for the duration of clinical trials. PATIENT OR PUBLIC CONTRIBUTIONS: Patients were invited to be participants in this study. A consumer has been included in the planning and oversite of the large multicentre trial.

PRECeDe Pilot: Prevention of neonatal respiratory distress with antenatal corticosteroids before elective caesarean section in women with diabetes - a feasibility randomised trial.

OBJECTIVE: The PRECeDe Pilot Trial was designed to determine the feasibility of undertaking a multicentre, randomised controlled trial (RCT) to assess the efficacy of antenatal corticosteroids administration within 7 days before elective caesarean section (CS) in women with pre-gestational diabetes (PGDM) or gestational diabetes (GDM). DESIGN: Triple blind, parallel group, placebo-controlled, pilot RCT. SETTING: Single-centre tertiary maternity hospital in Melbourne, Australia. POPULATION: Pregnant women with PGDM (type 1 or type 2 diabetes) or GDM booked for a planned CS scheduled between 35+0 and 38+6 weeks of gestation. METHODS: Eligible participants were randomised to receive two injections of either betamethasone 11.4 mg or normal saline placebo, 24 hours apart within 7 days before CS scheduled between 35+0 and 38+6 weeks of gestation. MAIN OUTCOME MEASURE: The proportion of eligible women who consented and were randomised. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12619001475134. RESULTS: Of 537 women eligible, 182 were approached and 47 (26%) were recruited. Of these, 22 were allocated to the betamethasone group and 25 were allocated to the placebo group. There were no serious adverse events related to participation. CONCLUSION: It is feasible to undertake a triple-blind, placebo-controlled RCT investigating the efficacy of antenatal corticosteroids in preventing respiratory morbidity in infants of women with PGDM or GDM who are undergoing an elective CS between 35+0 and 38+6 weeks.

Comparison of Musculoskeletal Injury and Behavioral Health Diagnoses Among U.S. Army Active Duty Servicewomen in Ground Combat and Non-Ground Combat Military Occupational Specialties.

INTRODUCTION: The U.S. Army's Soldier 2020 program, which started in January 2016, was designed to achieve full integration of women in all military occupational specialties. This study was undertaken to determine differences in risk of musculoskeletal injury and behavioral health (BH) disorders among U.S. Army Active Duty Servicewomen (ADSW) in ground combat military occupational specialties (MOS) versus those in non-ground combat MOS since the start of the program until January 2019. MATERIALS AND METHODS: Using healthcare claims data from the Military Health System's Data Repository we conducted a cross-sectional study on ADSW from January 1, 2016 to January 1, 2019 and categorized them as either ground combat specialists (GCSs) or non-ground combat specialists (NGCSs). We identified all female soldiers in our cohort with a musculoskeletal injury (MSKI) and/or BH diagnosis during the study period. A multivariable logistic regression, adjusted by pregnancy or delivery status, was used to assess risk factors associated with GCS and included soldier age, race, body mass index (BMI), tobacco use, alcohol/substance use, and MSKI and BH status as predictor variables. RESULTS: A total of 92,443 U.S. Army ADSW were identified, of whom 3,234 (3.5%) were GCS (infantry, field artillery, cavalry/armor, and air defense) and 89,209 (96.5%) were in non-ground combat billets. A large difference was observed when comparing the age of the population by occupation; GCS women were predominantly between the ages of 18-23 years (71.9%), compared to NGCS women aged 18-23 (41.0%). Top MSKI and BH diagnoses for both occupations were joint pain (44.9% GCS, 50.2% NGCS) and adjustment disorders (26.2% GCS, 28.0% NGCS). GCS women had lower odds for musculoskeletal injury (0.86 AOR, 0.79-0.93 CI, P = 0.0002), obesity per BMI classification (0.82 AOR, 0.70-0.97 CI, P = 0.0214), and BH disorders (0.87 AOR, 0.80-0.95 CI, P = 0.0019); and higher odds for tobacco use (1.44 AOR, 1.27-1.63 CI, P < 0.0001), substance use (1.36 AOR, 1.04-1.79 CI, P = 0.0257), and alcohol use (1.18 AOR, 1.02-1.38 CI, P = 0.0308) when compared to NGCS women. CONCLUSIONS: With the increasing focus on soldier medical readiness in today's U.S. Army, the health of all soldiers is of paramount concern to command groups, unit leaders, and individual soldiers. The integration of women into ground combat military occupational specialties is a relatively new program; further longitudinal research of these groups should follow, focusing on their progression and improvement in soldier readiness, overall health, and the well-being of all servicewomen.

Maternal thrombin generation and D-dimer levels in obesity and pregnancy: results from the maternal thrombin generation in obesity and pregnancy (MaTOPs) study.

Venous thromboembolic disease (VTE) risk increases five-fold antenatally and 14-fold during the puerperium. Obesity significantly increases this risk. The D-dimer assay and more novel Calibrated Automated Thrombogram (CAT) assay laboratory tests display potential for use in VTE risk stratification in pregnancy, although to date, research in the performance characteristics of these tests in obese and nonobese pregnant populations is limited. The aim of this study was to compare D-dimer and thrombin generation levels in obese and nonobese pregnant women. Pregnant women were recruited and categorised, as obese (BMI ≥30) or nonobese (BMI 18.5-25). Blood was collected at 26-28 weeks' gestation, 36-40 weeks' gestation and 6-12 weeks postpartum and D-dimer concentrations and endogenous thrombin potential (ETP) were determined. Student's t-test was used to analyse differences in mean D-dimer and ETP. At 36-40 weeks, obese pregnant women had higher D-dimer concentrations (P = 0.001) but lower ETP levels compared with nonobese women (P = 0.044). D-dimer was higher in nonobese than in obese women at 6-12 weeks postpartum (P = 0.026). There was no difference in mean D-dimer (P  = 0.825) and mean ETP (P  = 0.424) between obese and nonobese women at 26-28 weeks. No difference was observed in mean ETP at 6-12 weeks postpartum (P  = 0.472). ETP was lower in both obese and nonobese women postpartum than during pregnancy. D-dimer was lower in obese women but not in nonobese women postpartum. D-dimer concentrations and ETP were not significantly different during multiple time points in pregnancy and postpartum between obese and nonobese pregnant women suggesting limited utility in VTE risk assessment in obese pregnant women.

Antenatal vaccine uptake: A cross-sectional study investigating factors influencing women's choices in pregnancy.

BACKGROUND: Seasonal influenza and pertussis cause significant morbidity and mortality among expectant mothers and infants. Vaccination during the antenatal period is an important public health intervention, minimising rates of maternal, neonatal and infant infection. AIMS: The primary aim of this project was to establish the rates of antenatal vaccine uptake. Secondly, the study aimed to determine socio-demographic factors significant to vaccine uptake. Thirdly, the project aimed to produce a thematic analysis of the factors affecting vaccination uptake during pregnancy. MATERIALS AND METHODS: A cross-sectional observational study was conducted among women attending a large maternity hospital, in the western suburbs of Melbourne, for perinatal care. Data were collected via self-completed questionnaires after delivery. Data from the questionnaires were entered into an electronic database, and STATA was used to undertake correlation analysis. RESULTS: Over a 12-month period 1678 women completed questionnaires and 1305 were eligible for further analysis. The uptake of influenza vaccine was 48.3%, pertussis vaccine uptake was higher, at 82.9%. Uptake of influenza and pertussis vaccines strongly correlated with recommendations from healthcare providers (odds ratios 29.7 and 63.8 respectively). Maternal country of birth, age and parity were significant predictors of vaccine uptake. In thematic analysis, healthcare provider recommendation and the perceived risk of the disease were factors resulting in vaccination. CONCLUSION: This study determined the rate of antenatal vaccine uptake and significant socio-demographic determinants affecting uptake at a large maternity hospital in metropolitan Melbourne. Ensuring healthcare providers recommend vaccination is likely to improve coverage.

Department of Defense end-of-season influenza vaccine effectiveness estimates for the 2017-2018 season.

The Department of Defense (DoD) generates influenza vaccine effectiveness (VE) estimates each season. The Armed Forces Health Surveillance Branch Air Force (AFHSB-AF) satellite, Naval Health Research Center Operational Infectious Disease Directorate at the Naval Health Research Center (NHRCOID), and the Armed Forces Health Surveillance Branch (AFHSB) all conduct influenza surveillance and perform test-negative case-control analyses to estimate seasonal influenza VE for DoD populations. The mid-season estimates contribute to the aggregate data utilized by the Food and Drug Administration's Vaccine and Related Biological Products Advisory Committee to select the composition of the influenza vaccine for the next influenza season. The full season data provide DoD with direct estimates for force health protection decisions. The 2017-2018 DoD influenza season was predominated by influenza A(H3N2) with varying levels of adjusted overall VE estimates. AFHSB-AF satellite's VE for dependents was moderate at 49% (95% confidence interval [CI]: 42%-55%) for all strains. NHRC-OID's VE among dependents was moderate-high at 63% (95% CI: 50%-73%) for all strains. AFHSB service member VE was low at 18% (95% CI: 4%-30%). These estimates highlight the need for continued influenza surveillance and VE estimate calculations each season among the different DoD populations as circulating strains and VE may change annually.