Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants.

BACKGROUND: Whether vaccination during pregnancy could reduce the burden of respiratory syncytial virus (RSV)-associated lower respiratory tract illness in newborns and infants is uncertain. METHODS: In this phase 3, double-blind trial conducted in 18 countries, we randomly assigned, in a 1:1 ratio, pregnant women at 24 through 36 weeks' gestation to receive a single intramuscular injection of 120 µg of a bivalent RSV prefusion F protein-based (RSVpreF) vaccine or placebo. The two primary efficacy end points were medically attended severe RSV-associated lower respiratory tract illness and medically attended RSV-associated lower respiratory tract illness in infants within 90, 120, 150, and 180 days after birth. A lower boundary of the confidence interval for vaccine efficacy (99.5% confidence interval [CI] at 90 days; 97.58% CI at later intervals) greater than 20% was considered to meet the success criterion for vaccine efficacy with respect to the primary end points. RESULTS: At this prespecified interim analysis, the success criterion for vaccine efficacy was met with respect to one primary end point. Overall, 3682 maternal participants received vaccine and 3676 received placebo; 3570 and 3558 infants, respectively, were evaluated. Medically attended severe lower respiratory tract illness occurred within 90 days after birth in 6 infants of women in the vaccine group and 33 infants of women in the placebo group (vaccine efficacy, 81.8%; 99.5% CI, 40.6 to 96.3); 19 cases and 62 cases, respectively, occurred within 180 days after birth (vaccine efficacy, 69.4%; 97.58% CI, 44.3 to 84.1). Medically attended RSV-associated lower respiratory tract illness occurred within 90 days after birth in 24 infants of women in the vaccine group and 56 infants of women in the placebo group (vaccine efficacy, 57.1%; 99.5% CI, 14.7 to 79.8); these results did not meet the statistical success criterion. No safety signals were detected in maternal participants or in infants and toddlers up to 24 months of age. The incidences of adverse events reported within 1 month after injection or within 1 month after birth were similar in the vaccine group (13.8% of women and 37.1% of infants) and the placebo group (13.1% and 34.5%, respectively). CONCLUSIONS: RSVpreF vaccine administered during pregnancy was effective against medically attended severe RSV-associated lower respiratory tract illness in infants, and no safety concerns were identified. (Funded by Pfizer; MATISSE ClinicalTrials.gov number, NCT04424316.).

Reducing Perineal Lacerations Through Team-Based Simulation.

INTRODUCTION: Vaginal deliveries that result in perineal trauma involve significant morbidity to women. Multiple strategies have been identified to reduce the risk of severe perineal lacerations. The objective of this study was to evaluate the effectiveness of an interprofessional simulation-based teams-training program aimed at reducing severe perineal lacerations during childbirth. METHODS: A quasi-experimental pre-post single-group design was used to examine the performance of labor and delivery personnel at a large multihospital system after participating in a mixed-modality simulation program for reducing perineal lacerations. Multiple educational strategies aimed at management of second stage of labor (including laboring down, warm compresses, coaching, positioning, perineal support, controlled delivery of fetal head, and mediolateral episiotomy techniques) were taught using patients, task trainers, and a standardized curriculum during interprofessional educational sessions. Primary study outcomes were as follows: (a) pre-post differences in knowledge; (b) pre-post differences in team performance assessments; and (c) pre-post differences in safety culture. Secondary outcomes were severe perineal laceration rates. RESULTS: During an 18-month period, 675 personnel in 4 hospitals participated in the program. Significant improvement was noted in pre-post scores of knowledge (59.86%, 93.87%, P < 0.0001), performance (36.54%, 93.45%, P < 0.0001), and safety culture (3.24, 1.45, 1 = high, 5 = low, P < 0.0001). Severe perineal laceration rates decreased by 33.38% since initiation. Rates fluctuated with the addition of new personnel and renewed educational programs. CONCLUSIONS: A multimodal interprofessional simulation program of strategies to prevent severe perineal lacerations significantly improved knowledge, skills, and attitudes in labor and delivery personnel within a healthcare system. Severe perineal laceration rates were reduced.

Pregnancy-associated breast cancer.

Breast cancer is the second most common malignancy affecting pregnancy. Pregnancy-associated breast cancer (PABC) is defined as breast cancer diagnosed during pregnancy or in the first postpartum year. Because PABC is a relatively rare event surrounded by multiple variables, few studies address the best management and treatment options. We present a case of PABC to illustrate and highlight some of the recommendations for treatment, obstetric care, delivery management, and cancer surveillance.