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.

Percepción de los ginecólogos sobre la situación actual de los dispositivos intrauterinos durante el consejo contraceptivo en España para distintos perfiles de usuaria / Perception of gynecologists on the current situation of intrauterine devices during contraceptive advice in Spain for different user profiles

Objetivo: comunicar las percepciones de ginecólogos españoles sobre el uso del dispositivo intrauterino en distintos perfiles de usuaria. Materiales y métodos: estudio transversal descriptivo. 94 ginecólogos de diferentes regiones de España cumplimentaron un cuestionario sobre la situación del dispositivo intrauterino durante el consejo contraceptivo. Las valoraciones fueron consensuadas en una reunión nacional. Resultados: un 73% de los ginecólogos se manifestaron de acuerdo en recomendar los dispositivos intrauterinos en mujeres nulíparas. Sin embargo, solo un 52% declaró prescribirlo en ese perfil con frecuencia. Asimismo, un 93% de los participantes mostró acuerdo para afirmar la existencia de ideas preconcebidas sobre el dispositivo intrauterino y un 79% para afirmar que una mayor accesibilidad aumentaría su recomendación. Conclusiones: se sugiere incluir los distintos tipos de dispositivos intrauterinos durante el consejo contraceptivo según el perfil de cada usuaria, independientemente de edad o paridad, y preferiblemente los hormonales en mujeres candidatas (AU)

Objective: To communicate the perceptions of Spanish gynecologists about the use of intrauterine devices in different user profiles. Materials and methods: Cross-sectional descriptive study. 94 gynecologists answered a questionnaire related to the current situation of intrauterine devices in contraceptive counseling. Answers and considerations were validated in a national meeting. Results: 73% of gynecologists showed their agreement to recommend intrauterine devices to nulliparous women. However, only 52% declared to often prescribe these methods to these users. In addition, 93% of participants agreed to describe the existence of preconceived notions about intrauterine devices, and 79% agreed to declare that better accessibility would increase intrauterine devices prescription rates. Conclusions: Considering all intrauterine devices types during contraceptive counseling was advised, giving preference to hormone-based methods in the appropriate women. Acknowledging the different user profiles was also recommended, regardless of age and parity (AU)