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    Maternal, fetal, and neonatal serious adverse events associated with low-dose aspirin during the first trimester of pregnancy: A secondary analysis of the Aspirin Supplmentation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN) trial
    (Elsevier BV, 2025)
    Rodriguez-Sibaja, Maria J.
    ;
    Gálvez Rubalcava, Natalia
    ;
    Hagerman-Sucar, Gonzalo
    ;
    Alcocer González-Camarena, Paulina
    ;
    Gómez Woodworth, Juan Ramón
    Background: Low-dose aspirin (LDA) has been shown to reduce the risk of preterm preeclampsia, particularly when initiated early in pregnancy. However, the safety of starting LDA before 11 0/7 weeks of gestation remains unclear. Objective: To assess whether initiating LDA before 11 0/7 weeks of gestation is associated with increased maternal, fetal, or neonatal serious adverse events compared to later initiation. Study Design: This secondary analysis of the ASPIRIN (Aspirin Supplmentation for Pregnancy Indicated Risk Reduction In Nulliparas) trial included 11,879 nulliparous women with singleton pregnancies randomized to receive LDA (81 mg/d) or placebo between 6 0/7–13 6/7 weeks of gestation. Severe adverse events (ie, maternal death, antepartum hemorrhage, postpartum hemorrhage, anemia, preeclampsia or eclampsia, preterm labor, hypertension admission, fever or infection, fetal loss, neonatal death up to 28 days, miscarriage, abortion, or medical termination of pregnancy, and congenital anomalies) were analyzed based on gestational age at LDA initiation (<11 0/7 vs ≥11 0/7 weeks). Furthermore, congenital anomalies were assessed for therapy initiated during the embryonic (ie, <9 0/7 weeks) or fetal period. Interaction tests were performed via logistic regression models on the ASPIRIN trial safety population (ie, participants who received at least one dose of LDA or placebo) and on the subset of participants who had an adherence to the exposure of ≥90%. Results: Among the 11,879 eligible participants for this secondary analysis, 62% (n=7324) initiated the allocated exposure before 11 0/7 weeks vs 38% (n=4555) that initiated LDA or placebo at a later gestational age. Furthermore, in this population, 84.4% (n=10,030) had an adherence to the intervention of 90% or more. Moreover, the proportion of adherence of ≥90% to LDA or placebo was similar between strata (84.6% [n=6195] for <11 0/7 vs 84.2% [n=3835] ≥11 0/7 weeks, P=.570). No significant differences were observed in the maternal, fetal, or neonatal adverse events described above based on the timing of LDA initiation (P>.05 for all interactions). Likewise, congenital anomalies did not significantly differ between embryonic and fetal exposure periods (interaction P-value = .095). Results remained consistent in participants who had an adherence to the exposure of ≥90%. Conclusions: LDA (81 mg/d) initiated before 11 0/7 weeks of gestation may not increase the risk of maternal, fetal, or neonatal serious adverse events or congenital anomalies. These findings provide reassuring evidence of the safety of LDA exposure during early pregnancy. ©The authors ©American Journal of Obstetrics & Gynecology MFM © Elsevier BV.
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    Prediction of preeclampsia before 11th week of gestation: a secondary analysis of the ASPIRIN trial
    (Elsevier BV, 2025)
    Capdeville, Gabriela
    ;
    Godinez-Medina, Andrea
    ;
    Copado-Mendoza, Diana Y.
    ;
    Acevedo-Gallegos, Sandra
    ;
    Rodriguez-Bosch, Mario R.
    Background: Early screening for preeclampsia is crucial for preventing adverse maternal and fetal events. Current first-trimester algorithms for predicting preeclampsia are designed to evaluate individual risk between 11.0 and 13.6 weeks of gestation based on various maternal characteristics while integrating biophysical and biochemical features. However, there is limited information regarding risk assessment during earlier stages of pregnancy (i.e., <11.0 weeks gestation). Objective: To develop a prediction model for preeclampsia/eclampsia before 11.0 weeks of gestation as a proof-of-concept in a secondary analysis of the ASPIRIN trial. Study design: This study is a secondary analysis of the ASPIRIN trial, a multinational, randomized, double-blind, placebo-controlled trial. The ASPIRIN trial database, obtained from NICHD DASH, included 11,976 nulliparous pregnant women aged 18–40 with gestational ages of 6.0–13.6 weeks at randomization. Participants were assigned to receive either aspirin (81 mg/day) or placebo until 36.0 weeks or delivery. This secondary analysis included pregnancies delivered at ≥20.0 weeks, excluding those in the aspirin group or with gestational ages ≥11.0 weeks at enrollment. The composite outcome was preeclampsia/eclampsia, as reported in the ASPIRIN trial. Predictor variables available in the dataset included maternal age, education (4 levels), body mass index (BMI kg/m2), gravidity, baseline hemoglobin, baseline systolic blood pressure, and baseline diastolic blood pressure. Logistic regression, with logarithmic transformation for continuous variables, was used to develop the model. The area under the ROC curve with a 95% confidence interval (CI) estimated via bootstrap resampling (1,000 iterations) and the P-value of the Hosmer-Lemeshow statistical test are reported as discrimination and calibration measures. This study used the entire available sample using a complete case approach. Results: A total of 3421 participants met the inclusion criteria, with a cumulative incidence of preeclampsia/eclampsia of 2.9% (99/3,421). Maternal age (21.96 ± 4.13 vs 20.86 ± 3.21, P<.001) and BMI (22.49 ± 4.77 vs 20.79 ± 3.55, P<.001) were significantly higher in the preeclampsia/eclampsia group. Gravidity was lower (P=.023), and hemoglobin levels were slightly elevated (11.88 ± 1.52 g/dL vs 11.50 ± 1.61 g/dL, P=.019) in the preeclampsia/eclampsia group. Educational level (P=.070), systolic blood pressure (P=.720), and diastolic blood pressure (P=.390) showed no significant differences between groups. The logistic regression model yielded an AUC of 0.69 (95% CI 0.63–0.74), and the Hosmer-Lemeshow test P-value was 0.094, indicating acceptable discrimination and calibration. Conclusions: This proof-of-concept logistic regression model using first-trimester maternal characteristics demonstrated acceptable predictive performance for preeclampsia/eclampsia before 11.0 weeks of gestation. During this critical period, several interventions could be proposed to reduce preeclampsia risk, including medication adjustments, lifestyle changes, and appropriate referral if needed. Further studies are required to validate these findings and assess their clinical utility in different settings. © The authors © Elsevier.