4 research outputs found

    Vacuum-assisted birth in maternal lateral posture versus lithotomy. A simulation study

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    Objective: Maternal lateral postures provide advantages during childbirth. This study aims to investigate the feasibility of assisting vacuum births in maternal lateral postures in a simulation model. Study design: In a simulation model, four obstetricians and four medical students were randomly allocated to perform vacuum-assisted births first in maternal lateral posture or lithotomy. A modification of Aldo Vacca’s 5- step technique was developed to assist vacuum-assisted births in lateral posture. The lateral distance, vertical distance, and distance from the cup center to the flexion point were measured for every placement of the cup. Results and conclusions: A total of 128 vacuum-assisted births were performed. The mean distance to the flexion point was 1.15 ± 0.71 cm for the lithotomy posture and 1.31 ± 0.82 cm for the lateral posture (P = 0.127). There were no statistically significant differences in vacuum extractor cup placement accuracy based on maternal posture. Performing vacuum-assisted births in maternal lateral posture is feasible in a simulation model. The technique is easy to learn, and the differences in cup placement between the lateral and lithotomy postures are smal

    Riesgo de transmisión de citomegalovirus congénito en el área norte de Madrid

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    Introduction: Cytomegalovirus (CMV) is the most common cause of congenital infection in developed countries. CMV-IgG avidity may be useful for pregnancy management. Method: Retrospective study of pregnant women with CMV-IgM+ and IgG+ in the first trimester at the La Paz Hospital (Madrid) between 2018 and 2022. Results: 98 pregnant women were included. CMV-IgG avidity was low in 63 cases (64%). Amniocentesis was performed in 62 cases, and 12 (19.3%) had positive CMV-PCR. Five newborns presented symptoms at birth (41.7%). Among pregnant women with high avidity (n=35), amniocentesis was performed in 19 (54%), all of which were negative. All newborns had negative urine CMV PCR. The risk of vertical transmission was significantly lower compared to pregnant women with low IgG avidity (p<0.0001). Conclusions: In the northern area of Madrid, the majority of CMV infections are primary infections. The risk of congenital CMV is very low when IgG avidity is high in the first trimester.Introducción: El citomegalovirus (CMV) es la causa más común de infección congénita en los países desarrollados. La avidez de CMV-IgG puede ser útil para el manejo de la gestación.  Método: Estudio retrospectivo de gestantes con CMV-IgM+ e IgG+ en el primer trimestre del embarazo controladas en el Hospital La Paz (Madrid) entre 2018 y 2022.  Resultados: Se incluyeron 98 gestantes. La avidez de CMV-IgG fue baja en 63 casos (64%). Se realizó amniocentesis en 62 casos y 12 (19,3%) tuvieron CMV-PCR positiva e infección fetal. Cinco recién nacidos presentaron síntomas al nacer (7,9%). Entre las gestantes con alta avidez (n=35), se realizó amniocentesis en 19 (54%), siendo todas negativas y teniendo todos PCR de CMV en orina negativa al nacimiento. El riesgo de transmisión vertical fue significativamente menor en comparación con las gestantes con baja avidez de IgG (p<0,0001). Conclusiones: En el área Norte de Madrid, la mayoría de las infecciones por CMV son primoinfecciones. El riesgo de CMV congénito es muy bajo cuando la avidez de IgG es alta (reactivación o enfermedad latente) en el primer trimestre

    Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus Vaccine (RSVPreF3) in Mothers and Their Infants : A Phase 2 Randomized Trial

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    Lay Summary What Is the Context? Infants, especially those less than 6 months of age, are at increased risk of lung infection caused by respiratory syncytial virus (RSV). However, this risk could be reduced with maternal vaccination against RSV during pregnancy. A previous clinical trial found that a vaccine candidate (named RSVPreF3) was well tolerated when given to non-pregnant women. What is New? In pregnant women, RSVPreF3 was also well tolerated. Occurrence of unsolicited adverse events was similar between vaccine and placebo recipients. None of the serious adverse events or events of interest for pregnant women or newborns were considered related to the study intervention. One month after vaccination, mothers who received RSVPreF3 had 11-15 times higher levels of antibodies against RSV than before vaccination. These antibody levels remained similar until 43 days after delivery. In the infants born to mothers vaccinated during pregnancy with RSVPreF3, antibody levels were highest at birth, when levels were higher than in their mothers, and declined through day 181 postbirth. What Is the Impact? RSVPreF3 had an acceptable safety risk profile in pregnant women and their babies. This vaccine induced potent immune responses against RSV, with maternal antibodies transferred to infants of the vaccinated mothers.Background In a phase 1/2 study, a maternal respiratory syncytial virus vaccine candidate (RSVPreF3) demonstrated an acceptable safety profile and efficiently increased RSV-specific humoral immune responses in non-pregnant women. Methods In this phase 2 observer-blind, placebo-controlled, randomized clinical trial (NCT04126213), the safety of RSVPreF3 (60 or 120 mu g), administered during late second or third trimester, was evaluated in 213 18- to 40-year-old healthy pregnant women through 6 months postdelivery and their offspring through infancy; immunogenicity was evaluated through day 43 postdelivery and day 181 postbirth, respectively. Results RSVPreF3 was well tolerated. No pregnancy-related or neonatal adverse events of special interest were considered vaccine/placebo related. In the 60 and 120 mu g RSVPreF3 groups: (1) neutralizing antibody (nAb) titers in mothers increased 12.7- and 14.9-fold against RSV-A and 10.6- and 13.2-fold against RSV-B, respectively, 1 month postvaccination and remained 8.9-10.0-fold over prevaccination at day 43 postdelivery; (2) nAb titers were consistently higher compared to placebo recipients; (3) placental transfer ratios for anti-RSVPreF3 antibodies at birth were 1.62 and 1.90, respectively, and (4) nAb levels in infants were highest at birth and declined through day 181 postbirth. Conclusions RSVPreF3 maternal vaccination had an acceptable safety risk profile and induced robust RSV-specific immune responses with successful antibody transfer to their newborns.In this phase 2 observer-blind, placebo-controlled, randomized clinical trial, RSVPreF3 maternal vaccination during late second or third trimester had an acceptable safety risk profile and induced robust RSV-specific immune responses with successful antibody transfer to their newborns.Peer reviewe
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