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Background High-throughput sequencing measurements of the vaginal microbiome have yielded intriguing potential relationships between the vaginal microbiome and preterm birth (PTB; live birth prior to 37 weeks of gestation). However, results across studies have been inconsistent. Results Here, we perform an integrated analysis of previously published datasets from 12 cohorts of pregnant women whose vaginal microbiomes were measured by 16S rRNA gene sequencing. Of 2039 women included in our analysis, 586 went on to deliver prematurely. Substantial variation between these datasets existed in their definition of preterm birth, characteristics of the study populations, and sequencing methodology. Nevertheless, a small group of taxa comprised a vast majority of the measured microbiome in all cohorts. We trained machine learning (ML) models to predict PTB from the composition of the vaginal microbiome, finding low to modest predictive accuracy (0.28–0.79). Predictive accuracy was typically lower when ML models trained in one dataset predicted PTB in another dataset. Earlier preterm birth (< 32 weeks, < 34 weeks) was more predictable from the vaginal microbiome than late preterm birth (34–37 weeks), both within and across datasets. Integrated differential abundance analysis revealed a highly significant negative association between L. crispatus and PTB that was consistent across almost all studies. The presence of the majority (18 out of 25) of genera was associated with a higher risk of PTB, with L. iners , Prevotella , and Gardnerella showing particularly consistent and significant associations. Some example discrepancies between studies could be attributed to specific methodological differences but not most study-to-study variations in the relationship between the vaginal microbiome and preterm birth. Conclusions We believe future studies of the vaginal microbiome and PTB will benefit from a focus on earlier preterm births and improved reporting of specific patient metadata shown to influence the vaginal microbiome and/or birth outcomes.

Although combustible cigarette smoking rates have declined in recent years, alternative tobacco product use, particularly electronic cigarette use (“vaping”), has increased among young adults. Recent studies indicate that vaping during pregnancy is on the rise, possibly due to the perception that it is a safer alternative to combustible cigarette smoking. However, e-cigarette aerosols may contain several newer, potentially toxic compounds, including some known developmental toxicants that may adversely impact both the mother and the fetus. However, there is paucity of studies that have examined the effects of vaping during pregnancy. While the adverse perinatal outcomes of cigarette smoking during pregnancy are well established, the specific risks associated with inhaling vaping aerosols during pregnancy requires more research. In this article, we discuss the existing evidence and knowledge gaps on the risks of vaping during pregnancy. Studies that investigate vaping-associated systemic exposure and its effects (i.e., biomarker analyses) and maternal and neonatal clinical health outcomes are needed to reach more robust conclusions. We particularly emphasize the need to go beyond comparative studies with cigarettes, and advocate for research that objectively evaluates the safety of e-cigarettes and other alternative tobacco products.

Background While a link between maternal anxiety diagnoses and adverse maternal and infant outcomes has been reported, there is a paucity of data regarding infant outcomes through the first year of life in those born to individuals with anxiety only and anxiety comorbid with other mental health conditions. Method The sample included 5,836,541 singleton liveborn infants in California from 2007–2020. Anxiety with and without depression or a non-depression mental health condition during pregnancy were identified from ICD codes from hospital discharge records. Adverse infant outcomes evaluated included emergency department (ED) visit, readmission, or death in the first year of life. Log-linear regression was used to calculate the crude (cRR) and adjusted (aRR) relative risk and 95% confidence interval (CI) of each outcome by mental health condition grouping. To fully consider the potential influence of co-variants, we examined four different adjusted risk calculations. Patterns of comorbidity and infant outcomes were also examined within payer for birth (as an indicator of income) and racial/ethnic groupings. Results Infants of birthing people diagnosed with anxiety alone or anxiety and depression had reduced ED visits (cRRs 0.93 and 0.85, respectively) and readmissions (cRRs 0.85 and 0.83) but an increased risk of death (cRRs 1.40 and 1.75) compared to those without any mental health condition. Infants of people with diagnoses of anxiety and other non-depression conditions during pregnancy faced higher risks across all metrics (ED visits and readmissions cRRs 1.14–1.20, death cRRs 2.07–3.81). Observed were often tempered in fully adjusted models. Conclusions Maternal anxiety diagnosis during pregnancy was associated with an elevated risk of infant death and was exacerbated by the presence of another mental health condition. These relationships were not explained by the presence of other related risks. These findings underscore the need for interventions for birthing people with anxiety, and particularly for those with comorbid mental health conditions.

Objective. Preterm birth (PTB) remains a major cause of neonatal morbidity and mortality. The association between PTB and infection is clear. The purpose of this report is to present a focused review of information on the use of antibiotics to prevent PTB. Methods. We performed a search of the PubMed database restricted to clinical trials or meta-analyses published in English from 1990 through May 2011 using keywords “antibiotics or antimicrobials” and “preterm.” Results. The search yielded 67 abstracts for review. We selected 31 clinical trials (n=26) or meta-analysis (n=5) for further full-text review. Discussion of each eligible clinical trial, its specific inclusion criteria, antibiotic regimen used, and study results are presented. Overall, trials evaluating antibiotic treatment to prevent preterm birth have yielded mixed results regarding any benefit. Conclusion. Routine antibiotic prophylaxis is not recommended for prevention of preterm birth.

Prophylactic oral azithromycin vs. placebo reduced maternal, but not neonatal, mortality/sepsis in the A-PLUS Randomized Trial. While prophylactic intrapartum azithromycin reduces maternal mortality/sepsis, it may promote antimicrobial resistance (AMR) in commensal bacteria,. Randomly selected women and their infants participating in A-PLUS were enrolled in a longitudinal cross-sectional sub-study to assess the presence of azithromycin resistance in selected bacteria in nasal cultures. Staphylococcus aureus and Streptococcus pneumoniae were cultured on selective agar, then azithromycin-containing agar to select for azithromycin resistant bacteria, identified biochemically. Azithromycin susceptibility was assessed by E-test. Nasal cultures were collected from women and infants between August 11, 2021 and September 18, 2023 during labor/day 1, day 7, 6 weeks, and 3, 6 and 12 months after delivery. The study enrolled 911 women and 915 liveborn infants at 8 sites in 7 countries. Azithromycin resistance in S aureus was higher and azithromycin susceptibility was lower in women receiving azithromycin compared with those receiving placebo on day 7 (P < 0.001), 6 weeks (P < 0.001) and 3 months (P = 0.009) after delivery. Azithromycin resistance in S aureus was also higher and azithromycin susceptibility was lower 6 weeks after delivery (P < 0.001) in infants born to women receiving azithromycin, Azithromycin resistance in S. pneumoniae was too sparse to interpret. There was an increase in prevalence of azithromycin resistance (or reduction in azithromycin susceptibility) in commensal nasal S. aureus between day 7, 6 weeks and 3 months in women exposed to azithromycin vs. placebo and only at 6 weeks in infants exposed to azithromycin vs. placebo. These differences between the azithromycin and placebo groups were no longer detected at 6 and 12 months post-partum in the women and after 6 weeks through 12 months in the infants.

Prophylactic oral azithromycin vs. placebo reduced maternal, but not neonatal, mortality/sepsis in the A-PLUS Randomized Trial. While prophylactic intrapartum azithromycin reduces maternal mortality/sepsis, it may promote antimicrobial resistance (AMR) in commensal bacteria,. Randomly selected women and their infants participating in A-PLUS were enrolled in a longitudinal cross-sectional sub-study to assess the presence of azithromycin resistance in selected bacteria in nasal cultures. Staphylococcus aureus and Streptococcus pneumoniae were cultured on selective agar, then azithromycin-containing agar to select for azithromycin resistant bacteria, identified biochemically. Azithromycin susceptibility was assessed by E-test. Nasal cultures were collected from women and infants between August 11, 2021 and September 18, 2023 during labor/day 1, day 7, 6 weeks, and 3, 6 and 12 months after delivery. The study enrolled 911 women and 915 liveborn infants at 8 sites in 7 countries. Azithromycin resistance in S aureus was higher and azithromycin susceptibility was lower in women receiving azithromycin compared with those receiving placebo on day 7 (P < 0.001), 6 weeks (P < 0.001) and 3 months (P = 0.009) after delivery. Azithromycin resistance in S aureus was also higher and azithromycin susceptibility was lower 6 weeks after delivery (P < 0.001) in infants born to women receiving azithromycin, Azithromycin resistance in S. pneumoniae was too sparse to interpret. There was an increase in prevalence of azithromycin resistance (or reduction in azithromycin susceptibility) in commensal nasal S. aureus between day 7, 6 weeks and 3 months in women exposed to azithromycin vs. placebo and only at 6 weeks in infants exposed to azithromycin vs. placebo. These differences between the azithromycin and placebo groups were no longer detected at 6 and 12 months post-partum in the women and after 6 weeks through 12 months in the infants.

Background: We monitored exposure to fine particulates (PM2.5), ozone, nitrogen dioxide (NO2), and ambient temperature for pregnant women with and without asthma. Methods: Women (n = 40) from the Breathe—Well-Being, Environment, Lifestyle, and Lung Function Study (2015–2018) were enrolled during pregnancy and monitored for 2–4 days. Daily pollutants were measured using personal air monitors, indoor air monitors, and nearest Environmental Protection Agency’s stationary monitors based on GPS tracking and home address. Results: Personal-monitor measurements of PM2.5, ozone, and NO2 did not vary by asthma status but exposure profiles significantly differed by assessment methods. EPA stationary monitor-based methods appeared to underestimate PM2.5 and temperature exposure and overestimate ozone and NO2 exposure. Higher indoor-monitored PM2.5 exposures were associated with smoking and the use of gas appliances. The proportion of waking-time during which personal monitors were worn was ~56%. Lower compliance was associated with exercise, smoking, being around a smoker, and the use of a prescription drug. Conclusions: Exposure did not vary by asthma status but was influenced by daily activities and assessment methods. Personal monitors may better capture exposures but non-compliance merits attention. Meanwhile, larger monitoring studies are warranted to further understand exposure profiles and the health effects of air pollution during pregnancy.

Systemic lupus erythematosus (SLE) is an autoimmune disease commonly encountered during pregnancy. The use of hydroxychloroquine (HCQ) for SLE treatment in pregnancy has been supported by a few small studies performed in populations dissimilar from populations in the United States. Our objective was to compare maternal and neonatal outcomes in pregnant patients with SLE treated with and without HCQ at a tertiary care center in the United States. We conducted a retrospective cohort study of patients with SLE and singleton gestations who delivered at the University of Alabama at Birmingham from 2006 to 2013. Patients treated with HCQ during pregnancy were compared with patients who did not receive HCQ. Key outcomes included maternal morbidities (hypertensive disorders, intrauterine growth restriction, preterm delivery, venous thromboembolism), disease-related morbidity, maternal death, and a composite of neonatal morbidity. Outcomes were compared using chi-square, Fisher exact, Wilcoxon rank sum, and tests. Odds of adverse outcomes were modeled with logistic regression. Seventy-seven patients with SLE were included for analysis; 47 (61%) were treated with HCQ and 30 (39%) were not. We found no differences in the rates of maternal morbidities or death between groups. Patients taking HCQ had increased rates of disease-related hospitalizations (43% vs 7%, <0.01) and inpatient rheumatology consultations (38% vs 10%, <0.01), increases that persisted after multivariable adjustments (adjusted odds ratio [aOR] 8.09, 95% confidence interval [CI] 1.60-40.9; aOR 4.50, 95% CI 1.08-18.6, respectively). Neonatal morbidity did not differ between groups. We found no differences in major maternal or neonatal outcomes in pregnant patients with SLE managed with HCQ.

IntroductionInduction of labour (IOL) is a commonly performed obstetric intervention, particularly when delivery is deemed more beneficial than continuing the pregnancy due to maternal or fetal indications. When the cervix is unfavourable for delivery, cervical ripening is performed prior to IOL. A wide variety of mechanical, pharmacological and combination methods are used, but the optimal approach balancing efficacy, safety and patient experience remains uncertain. Conventional aggregate data (AD) meta-analyses lack individual-level data, limiting exploration of patient-level factors for personalised medicine and do not address concerns about the trustworthiness of data presented in peer-reviewed randomised controlled trials (RCTs). This protocol describes an individual participant data (IPD) network meta-analysis (NMA) designed to evaluate and rank cervical ripening methods for IOL using only high quality, trustworthy data.Methods and analysisWe will identify eligible parallel-group RCTs enrolling pregnant women with a singleton, cephalic fetus at ≥34 weeks’ gestation requiring cervical ripening, through comprehensive searches of Ovid MEDLINE, Embase, Emcare, Scopus, Cochrane Pregnancy and Childbirth Register, WHO International Clinical Trials Registry Platform, clinicaltrials.gov and reference lists of prior reviews. The interventions we consider will be selected via Delphi consensus with international clinical experts. Eligible trial investigators will be invited to contribute de-identified IPD; AD will be used if IPD is unavailable. Trials will be assessed for trustworthiness using the Trustworthiness in RAndomised Clinical Trials checklist and the IPD Integrity Tool, with only eligible studies included in the primary analysis. All statistical analyses will follow a pre-specified statistical analysis plan (SAP) finalised before any analyses are conducted. A two-stage, contrast-based, frequentist IPD-NMA will compare cervical ripening methods for three co-primary outcomes: vaginal birth, composite adverse perinatal outcomes and composite adverse maternal outcomes. Subgroup analyses will assess effect modifiers (eg, parity, age and previous caesarean), with treatment rankings presented using the surface under the cumulative ranking curve and rank-heat plots. Sensitivity analyses will examine the impact of bias, missing data and population criteria.Ethics and disseminationThis study has been approved by the Monash University Human Research Ethics Committee (No. 48189). IPD will be de-identified and securely transferred for storage on a Monash University-hosted shared network drive. Findings will be disseminated via peer-reviewed publications, conference abstracts and the Cervical Ripening for Induction of Labour Collaborative Evidence Network Meta-Analysis (CIRCLE-NMA) website (https://circlenma.com). Patient and public involvement will guide the communication and interpretation of results.PROSPERO registration numberCRD420251077464.

Background The Azithromycin Prevention in Labor Use Study (A-PLUS), a large, multi-national randomized trial, was performed to evaluate the improvement of maternal and newborn outcomes following a single dose of azithromycin (AZ) given during labor. However, the immediate and long-term impact of this single dose on the microbiome and the development or prevalence of antimicrobial resistance are unknown. We designed a sub-study to assess AZ resistance of bacterial isolates from clinical infections and of three target bacteria ( Staphylococcus aureus , Streptococcus pneumoniae , and Escherichia coli ) from the serial surveillance of the nasopharynx and rectum. Additionally, the serially surveilled samples will be evaluated for changes to the microbiome and the resistome of the nasopharynx and rectum. Methods and Analysis As part of the large, randomized APLUS trial, maternal and neonatal clinical infections were monitored for up to 42 days postpartum, and samples collected for culture using site-specific routine methods. For this sub-study, cultured bacterial isolates will be assessed for AZ resistance using an antibiotic susceptibility method. Additionally, a random subset of maternal-neonatal dyads from the main trial will be selected for serial surveillance with aseptic swab collections of the nasopharynx and the rectum at baseline, and subsequently at 1-week, 6-weeks, 3-months, 6-months, and 12-months postpartum. The serial samples will undergo selective culturing of sentinel bacterial species and screened for AZ resistance. An additional set of serial samples will be stored for future microbiome and resistome analyses. Ethics and Dissemination The study protocol was reviewed, and ethics approval obtained from all the relevant ethical review boards at each research site. All participants will provide informed written consent prior to their enrollment. Results of the trial will be disseminated through peer-reviewed publications, presentations at relevant conferences, and at dissemination meetings with the ministries of health and local stakeholders at each research site. Trial Registration NCT03871491.