The Effect of Preconception-Initiated Low-Dose Aspirin on Human Chorionic Gonadotropin-Detected Pregnancy, Pregnancy Loss, and Live Birth : Per Protocol Analysis of a Randomized Trial.
The Effect of Preconception-Initiated Low-Dose Aspirin on Human Chorionic Gonadotropin-Detected Pregnancy, Pregnancy Loss, and Live Birth : Per Protocol Analysis of a Randomized Trial.
复制标题
DOI：
10.7326/m20-0469
复制
发表时间：
2021-05
影响因子：
39.2
通讯作者：
Schisterman EF
中科院分区：
文献类型：
--
作者：
Naimi AI;Perkins NJ;Sjaarda LA;Mumford SL;Platt RW;Silver RM;Schisterman EF
先前的一项大型随机试验表明，怀孕前开始服用低剂量阿司匹林(LDA)并不会对妊娠结局产生积极影响。然而，这项试验受到不依从性的影响，这不是意向治疗方法所能解释的。我们评估了先入为主的LDA对妊娠丢失和活产的每种方案的影响。我们使用阿司匹林对妊娠和生殖试验的影响来构建一个前瞻性队列，用于后期分析。美国四所大学的医疗中心有1227名年龄在18岁到40岁之间的女性，她们有1到2次怀孕失败的尝试。通过定期测量药瓶重量来评估小剂量阿司匹林或安慰剂的依从性。主要结果是hCG从妊娠测试和医疗记录中检测到怀孕、妊娠丢失和活产。与安慰剂相比，每百名受试者中，坚持每周5/7天的LDA可使hCG妊娠增加8例(95%CI 4.64，10.96)，活产增加15例(95%CI 7.65，21.15)，妊娠丢失减少6例(95%CI−12.00，−0.20)。此外，与服用安慰剂相比，受孕后开始服用LDA导致了估计效果的降低。此外，每周至少需要4/7天才能取得效果。根据方案，结果表明，怀孕前服用LDA，每周至少4天，可能会改善经历过一到两次妊娠损失的妇女的生殖结局。增加对每日LDA的坚持似乎是提高有效性的关键。ClinicalTrials.gov#NCT00467363
A previous large randomized trial indicated preconception-initiated assignment to low-dose aspirin (LDA) did not positively affect pregnancy outcomes. However, this trial was subject to nonadherence which is not accounted for with the intent-to-treat approach. We estimated per-protocol effects of preconception-initiated LDA on pregnancy loss and livebirth. We used the Effects of Aspirin on Gestation and Reproduction Trial to construct a prospective cohort for a post-hoc analysis. Four university medical centers in the U.S. 1,227 women between 18-40 years of age with 1-2 prior pregnancy losses attempting pregnancy. Adherence to low-dose aspirin or placebo, assessed by pill bottle weight measurements at regular intervals over follow-up. Primary outcomes were hCG detected pregnancies, pregnancy losses, and live births from pregnancy tests and medical records. Relative to placebo, adhering to LDA for 5/7 days per week led to 8 more hCG pregnancies (95% CI 4.64, 10.96), 15 more live births (95% CI 7.65, 21.15), and 6 fewer pregnancy losses (95% CI −12.00, −0.20), for every 100 women in the trial. Additionally, relative to taking placebo, postconception initiation of LDA led to a reduction in the estimated effects. Furthermore, a minimum of 4/7 days per week was needed to obtain effects. Per protocol results suggest taking LDA prior to conception at least 4 days per week may improve reproductive outcomes for women who have experienced one or two prior pregnancy losses. Increasing adherence to daily LDA appears key to improving effectiveness. ClinicalTrials.gov #NCT00467363