Immunogenicity, transplacental transfer of pertussis antibodies and safety following pertussis immunization during pregnancy: Evidence from a randomized, placebo-controlled trial.

BACKGROUND: Pertussis immunization during pregnancy is recommended in many countries. Data from large randomized controlled trials are needed to assess the immunogenicity, reactogenicity and safety of this approach. METHODS: This phase IV, observer-blind, randomized, placebo-controlled, multicenter trial assessed immunogenicity, transplacental transfer of maternal pertussis antibodies, reactogenicity and safety of a reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap) during pregnancy. Women received Tdap or placebo at 27-36 weeks' gestation with crossover ≤ 72-hour-postpartum immunization. Immune responses were assessed before the pregnancy dose and 1 month after, and from the umbilical cord at delivery. Superiority (primary objective) was reached if the lower limits of the 95% confidence intervals (CIs) of the pertussis geometric mean concentration (GMC) ratios (Tdap/control) in cord blood were ≥ 1.5. Solicited and unsolicited adverse events (AEs) and pregnancy-/neonate-related AEs of interest were recorded. RESULTS: 687 pregnant women were vaccinated (Tdap: N = 341 control: N = 346). Superiority of the pertussis immune response (maternally transferred pertussis antibodies in cord blood) was demonstrated by the GMC ratios (Tdap/control): 16.1 (95% CI: 13.5-19.2) for anti-filamentous hemagglutinin, 20.7 (15.9-26.9) for anti-pertactin and 8.5 (7.0-10.2) for anti-pertussis toxoid. Rates of pregnancy-/neonate-related AEs of interest, solicited general and unsolicited AEs were similar between groups. None of the serious AEs reported throughout the study were considered related to maternal Tdap vaccination. CONCLUSIONS: Tdap vaccination during pregnancy resulted in high levels of pertussis antibodies in cord blood, was well tolerated and had an acceptable safety profile. This supports the recommendation of Tdap vaccination during pregnancy to prevent early-infant pertussis disease. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02377349.

Hidrotórax fetal primario: experiencia propia y revisión de la literatura / Primary fetal hydrothorax: personal experience and a review of the literature

El hidrotórax fetal es una condición rara con una incidencia reportada de uno en cada 10.000-15.000 embarazos, y consiste en una acumulación severa de líquido en el espacio pleural. El propósito de este artículo es revisar tanto los aspectos básicos como el estado actual de esta condición, incidiendo principalmente en el diagnóstico, opciones de manejo, alternativas de tratamiento invasivo prenatal, y ofrecer la revisión de nuestra experiencia. En la ecografía prenatal el derrame pleural se aprecia como un área anecoica uni- o bilateral en el tórax que rodea los pulmones fetales. La evolución varía desde su resolución espontánea hasta su aumento progresivo y el posterior desarrollo de hidrops fetal y polihidramnios con un alto riesgo de parto pretérmino y muerte intrauterina o neonatal debido a que el efecto masa que produce puede causar hipoplasia pulmonar. El enfoque óptimo del manejo prenatal está todavía en debate ya que el curso natural de la enfermedad puede variar, pero es una condición seria con tasas de morbimortalidad elevadas y la terapia prenatal puede estar indicada en casos seleccionados(AU)

Fetal hydrothorax is a rare condition with a reported incidence of one in 10,000-15,000 pregnancies, and it is a severe accumulation of fluid in the pleural space. Pleural effusion is seen in prenatal ultrasound as a unilateral or bilateral non-echogenic area in the chest around the fetal lungs. The outcome varies from spontaneous resolution to its gradual increase and the subsequent development of fetal hydrops and polyhydramnios with a high risk of preterm delivery, stillbirth or neonatal death due to pulmonary hypoplasia. The optimal prenatal management is still unclear, since the natural course of the disease can vary, but it is a serious condition with a high morbidity and mortality and prenatal therapy may be indicated in selected cases. The purpose of this paper is to review both the basic aspects of the condition and the current status, focusing primarily on the diagnosis, management options, prenatal therapy alternatives, and provide a review of our experience(AU)