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INTRODUCTION: This study aims to evaluate the safety of discontinuing aspirin treatment at 24-28 weeks in women at high risk after first-trimester combined screening for preeclampsia (PE) and normal placental growth factor (PlGF) levels at 24-28 weeks of gestation. MATERIAL AND METHODS: This is a post hoc analysis of the StopPRE trial, conducted at nine Spanish maternity hospitals from September 2019 to September 2021. In the StopPRE trial, all high-risk single pregnancies identified during first-trimester screening for PE were treated with 150 mg of daily aspirin. Out of 1604 eligible women with a soluble fms-like tyrosine kinase-1 to PlGF ratio (sFlt-1/PlGF) ≤38 at 24-28 weeks, 968 were randomly assigned in a 1:1 ratio to either continue aspirin until 36 weeks (control group) or discontinue it (intervention group). In this secondary analysis, only women with PlGF ≥100 pg/mL at 24-28 weeks were included. As in the StopPRE trial, the non-inferiority margin was set at a 1.9% difference in preterm PE incidence between the groups. RESULTS: Among the 13 983 screened pregnant women, 1984 (14.2%) were deemed high-risk for preterm PE, of which 397 (20.0%) were ineligible, 636 declined participation, and 32 were excluded. Ultimately, 919 women with PlGF >100 pg/mL were randomized and included in this analysis. Preterm PE occurred in 0.9% of the intervention group (4 out of 465) and 1.5% of the control group (7 out of 454), indicating non-inferiority of aspirin discontinuation. There were no significant differences between the groups in adverse pregnancy outcomes before 37 weeks, at <34 weeks, or ≥37 weeks. Minor antepartum hemorrhage incidence was significantly lower in the intervention group (absolute difference, -5.96; 95% CI, -10.10 to -1.82). CONCLUSIONS: Discontinuation of aspirin treatment at 24-28 weeks in women with PlGF levels ≥100 pg/mL was non-inferior to continuing until 36 weeks for preventing preterm PE. However, these findings should be interpreted with caution, as they originate from a subanalysis of the StopPRE trial.
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To compare effectiveness and safety of the Cook's balloon with vaginal dinoprostone to induce labor in patients with previous cesarean section. Observational, and retrospective study that included pregnant women at ≥ 37 weeks' gestation, with unfavorable cervix, singleton pregnancy, intact membranes, and a previous cesarean section, who had undergone labor induction in the period 2014-2019. 170 patients (86 balloon-84 dinoprostone) were analyzed. The proportion of women achieving vaginal delivery within 24 h was higher in the dinoprostone than in double-balloon group (RR, 3.24; 95% CI, 1.36-7.72). No significant differences were detected in the first 48 h in vaginal deliveries (P = .749) or in cesarean section rates (P = .634). Nor were there differences in maternal or fetal safety profiles. A body mass index > 35 increased the risk of cesarean section by 1.53 times (P = .017) and a Bishop's test score < 3 by 1.91 times (P = .009). A vaginal delivery following a cesarean section decreased the probability of another cesarean section by 0.46 times (P = .039). Labor induction with vaginal dinoprostone achieves better vaginal delivery rates in the first 24 h vs Cook's balloon. While the difference in uterine rupture rate did not reach significance, this was higher in women receiving prostaglandin.
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OBJECTIVE: To assess whether aspirin treatment can be discontinued in pregnancies with normal uterine artery pulsatility index (≤90th percentile) at 24-28 weeks. DESIGN: Post-hoc analysis of a clinical trial. SETTING: Nine maternity hospitals in Spain. POPULATION OR SAMPLE: Pregnant individuals at high risk of pre-eclampsia at 11-13 weeks and normal uterine artery Doppler at 24-28 weeks. METHODS: All participants received treatment with daily aspirin at a dose of 150 mg. Participants were randomly assigned, in a 1:1 ratio, either to continue aspirin treatment until 36 weeks (control group) or to discontinue aspirin treatment (intervention group), between September 2019 and September 2021. In this secondary analysis, women with a UtAPI >90th percentile at 24-28 weeks were excluded. The non-inferiority margin was set at a difference of 1.9% for the incidence of preterm pre-eclampsia. MAIN OUTCOME MEASURES: Incidence of preterm pre-eclampsia. RESULTS: Of the 1611 eligible women, 139 were excluded for UtAPI >90th percentile or if UtAPI was not available. Finally, 804 were included in this post-hoc analysis. Preterm pre-eclampsia occurred in three of 409 (0.7%) women in the aspirin discontinuation group and five of 395 (1.3%) women in the continuation group (-0.53; 95% CI -1.91 to 0.85), indicating non-inferiority of aspirin discontinuation. CONCLUSIONS: Discontinuing aspirin treatment at 24-28 weeks in women with a UtAPI ≤90th percentile was non-inferior to continuing aspirin treatment until 36 weeks for preventing preterm pre-eclampsia.
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Aspirina , Pré-Eclâmpsia , Feminino , Humanos , Recém-Nascido , Gravidez , Aspirina/uso terapêutico , Pré-Eclâmpsia/prevenção & controle , Pré-Eclâmpsia/tratamento farmacológico , Ultrassonografia Doppler , Artéria Uterina/diagnóstico por imagem , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como AssuntoRESUMO
Importance: Aspirin reduces the incidence of preterm preeclampsia by 62% in pregnant individuals at high risk of preeclampsia. However, aspirin might be associated with an increased risk of peripartum bleeding, which could be mitigated by discontinuing aspirin before term (37 weeks of gestation) and by an accurate selection of individuals at higher risk of preeclampsia in the first trimester of pregnancy. Objective: To determine whether aspirin discontinuation in pregnant individuals with normal soluble fms-like tyrosine kinase-1 to placental growth factor (sFlt-1:PlGF) ratio between 24 and 28 weeks of gestation was noninferior to aspirin continuation to prevent preterm preeclampsia. Design, Setting, and Participants: Multicenter, open-label, randomized, phase 3, noninferiority trial conducted in 9 maternity hospitals across Spain. Pregnant individuals (n = 968) at high risk of preeclampsia during the first-trimester screening and an sFlt-1:PlGF ratio of 38 or less at 24 to 28 weeks of gestation were recruited between August 20, 2019, and September 15, 2021; of those, 936 were analyzed (intervention: n = 473; control: n = 463). Follow-up was until delivery for all participants. Interventions: Enrolled patients were randomly assigned in a 1:1 ratio to aspirin discontinuation (intervention group) or aspirin continuation until 36 weeks of gestation (control group). Main Outcomes and Measures: Noninferiority was met if the higher 95% CI for the difference in preterm preeclampsia incidences between groups was less than 1.9%. Results: Among the 936 participants, the mean (SD) age was 32.4 (5.8) years; 3.4% were Black and 93% were White. The incidence of preterm preeclampsia was 1.48% (7/473) in the intervention group and 1.73% (8/463) in the control group (absolute difference, -0.25% [95% CI, -1.86% to 1.36%]), indicating noninferiority. Conclusions and Relevance: Aspirin discontinuation at 24 to 28 weeks of gestation was noninferior to aspirin continuation for preventing preterm preeclampsia in pregnant individuals at high risk of preeclampsia and a normal sFlt-1:PlGF ratio. Trial Registration: ClinicalTrials.gov Identifier: NCT03741179 and ClinicalTrialsRegister.eu Identifier: 2018-000811-26.
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Aspirina , Pré-Eclâmpsia , Nascimento Prematuro , Suspensão de Tratamento , Adulto , Feminino , Humanos , Recém-Nascido , Gravidez , Aspirina/efeitos adversos , Aspirina/uso terapêutico , Biomarcadores/sangue , Hemorragia/sangue , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Período Periparto , Fator de Crescimento Placentário/sangue , Pré-Eclâmpsia/sangue , Pré-Eclâmpsia/prevenção & controle , Complicações na Gravidez/sangue , Complicações na Gravidez/induzido quimicamente , Complicações na Gravidez/prevenção & controle , Primeiro Trimestre da Gravidez , Nascimento Prematuro/sangue , Nascimento Prematuro/prevenção & controle , Receptor 1 de Fatores de Crescimento do Endotélio Vascular/sangueRESUMO
INTRODUCCIÓN Y OBJETIVOS: La mayoría de las sociedades científicas recomiendan el parto vaginal del segundo gemelo siempre que el primer gemelo esté en presentación cefálica. En estos casos existe controversia cuánto tiempo transcurrido entre el parto de ambos es determinante en el resultado adverso del segundo gemelo. El objetivo de este estudio es examinar cómo influye dicho intervalo en el resultado perinatal precoz en nuestro Centro y el coste de las estancias neonatales y maternas. MÉTODOS: Estudio de cohortes retrospectivo entre mayo de 2014 y diciembre de 2018. Se comparó el resultado neonatal adverso estableciendo puntos de corte de intervalo entre el nacimiento de 10 y 30 minutos. Así mismo, se examinó la relación de otras variables del parto con el desenlace neonatal y se calcularon los costes de las estancias neonatales y maternas. RESULTADOS: Se incluyeron 128 partos gemelares vaginales asistidos en el Hospital Universitario Nuestra Señora de la Candelaria. Se evidenció triple tasa de resultado neonatal adverso en el grupo de más de 10 minutos (p=0,026 y OR 2,4) y tres veces peor en el de más de 30 minutos (p=0,013 y OR 6,4). Se obtuvo una correlación lineal negativa significativa entre el intervalo intergemelar y el pH umbilical. La prematuridad y el bajo peso al nacer fueron predictores de un mal desenlace neonatal. CONCLUSIONES: No parece recomendable que el intervalo intergemelar se prolongue más allá de los 30 minutos. Es seguro recomendar el parto vía vaginal en gestaciones gemelares siempre que el primero esté en presentación cefálica.
INTRODUCTION AND OBJECTIVES: Most scientific societies recommend vaginal delivery of the second twin when the first twin is in cephalic presentation. In these cases, there is controversy over how much inter-twin interval is decisive in the adverse outcome of the second twin. The aim of this study is to examine whether inter-twin delivery interval affects immediate perinatal outcome and the cost of neonatal and maternal stays. METHODS: Retrospective cohort study including 128 twin vaginal births attended in the Hospital Universitario Nuestra Señora de la Candelaria between May 2014 and December 2018. We compared the presence of composite adverse neonatal outcome by establishing interval cut-off points between birth of 10 and 30 minutes. Likewise, the relationship of other delivery associated variables with neonatal outcome was examined. Health care costs were calculated. RESULTS: There was a higher rate of composite adverse neonatal outcome in the 10 minute-group (p = 0.026, OR 2.4) and three times higher in the 30 minute-group (p = 0.013, OR 6.4). A significant negative linear correlation was obtained between birth interval and umbilical artery pH. Prematurity and low birth weight were predictors of a poor neonatal outcome. CONCLUSION: Our data suggests that inter-twin delivery interval shouldn't be prolonged beyond 30 minutes. Vaginal delivery is a safe option in twin gestations providing the first twin is in a cephalic presentation, regardless of the second twin presentation.