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美国母婴队列研究:基线结局及药物配给情况的描述与患病率

The AMerican PREGNANcy Mother-Child CohorT: description and prevalence of baseline outcomes and medication dispensing.

作者信息

Leal Lisiane F, Sheehy Odile, Gorgui Jessica, Bérard Anick

机构信息

Research Center, CHU Sainte-Justine, Montreal, QC, Canada.

Faculty of Pharmacy, University of Montreal, Montreal, QC, Canada.

出版信息

Front Pharmacol. 2025 Aug 5;16:1608403. doi: 10.3389/fphar.2025.1608403. eCollection 2025.

Abstract

PURPOSE

This study aims to present the AMerican PREGNANcy Mother-Child CohorT (AM-PREGNANT) and its maternal and linked-child characteristics.

METHODS

AM-PREGNANT was built using the Merative™ MarketScan® Commercial Database. We updated and implemented a hierarchical algorithm using ICD-9-CM and ICD-10-CM codes to identify pregnancies in individuals aged 15-45 years (2003-2021). A unique family identifier linked mothers to their children. Enrollment required continuous coverage for 90 days before, during, and 42 days after pregnancy for the mothers and 1 year after birth for the linked children. Pregnancy outcomes were categorized as deliveries, spontaneous abortions, and induced abortions. We characterized AM-PREGNANT (2004-2020) by sociodemographic factors, pregnancy history, comorbidities, and medication dispensing by pregnancy outcome. Medication dispensing, identified through filled prescriptions using drug claims, was analyzed for the 90 days before pregnancy until the last menstrual period (LMP), throughout pregnancy, and from delivery through the postpartum period. Linked children were assessed for low birth weight (LBW), preterm birth, congenital malformations, and other characteristics. Maternal and gestational age distributions were compared with United States (US) national estimates.

RESULTS

We identified 7,991,200 pregnancies from 6,079,647 persons (2003-2021). Applying continuous enrollment criteria and restricting the study period to 2004-2020 resulted in 4,767,208 pregnancies. Of these, 76.9% resulted in deliveries, 17.3% were spontaneous abortions, and 5.9% were induced abortions. The established linked mother-child cohort comprises 2,578,990 pregnancies. The mean maternal age in the linked mother-child cohort was 30.4 years (SD, 5.4). The mean gestational age at delivery was 38.6 weeks. Infections were the most prevalent maternal comorbidity (11.8%). Among deliveries, the prevalence of medication dispensing in mothers before, during, and after pregnancy were 63.2%, 88.7%, and 82.9%, respectively. Among linked children, 52.1% were male, 12.0% were preterm, and 4.5% had low birth weight. The prevalence of major congenital malformations was 13.1%. The characteristics of children with continuous enrollment were similar to those without, except for medication dispensing during the first year of life (62.9% vs. 45.6%). Both maternal and gestational age distributions of AM-PREGNANT were comparable to the US national estimates.

CONCLUSION

AM-PREGNANT is a valuable cohort for studying medication safety in mothers and children. Strict enrollment criteria ensured reliable data, minimizing the risk of misclassification. This cohort is a key resource for multi-country perinatal pharmacoepidemiological studies.

摘要

目的

本研究旨在介绍美国母婴队列研究(AM-PREGNANT)及其孕产妇和关联儿童的特征。

方法

AM-PREGNANT是利用默克多源数据库(Merative™ MarketScan® Commercial Database)构建的。我们更新并实施了一种分层算法,使用国际疾病分类第九版临床修订本(ICD-9-CM)和国际疾病分类第十版临床修订本(ICD-10-CM)编码来识别15至45岁(2003 - 2021年)个体中的妊娠情况。一个独特的家庭标识符将母亲与其子女关联起来。入组要求母亲在怀孕前、怀孕期间和怀孕后42天以及关联儿童出生后1年持续参保90天。妊娠结局分为分娩、自然流产和人工流产。我们根据社会人口统计学因素、妊娠史、合并症以及按妊娠结局划分的药物配给情况对AM-PREGNANT(2004 - 2020年)进行了特征描述。通过使用药品报销记录的已配药处方识别药物配给情况,分析了怀孕前90天直至末次月经(LMP)、整个孕期以及从分娩到产后阶段的情况。对关联儿童进行低出生体重(LBW)、早产、先天性畸形及其他特征的评估。将孕产妇和孕周分布与美国国家估计数据进行比较。

结果

我们从6,079,647人中识别出7,991,200例妊娠(2003 - 2021年)。应用持续参保标准并将研究期限制在2004 - 2020年,得到4,767,208例妊娠。其中,76.9%为分娩,17.3%为自然流产,5.9%为人工流产。已建立的关联母婴队列包括2,578,990例妊娠。关联母婴队列中母亲的平均年龄为30.4岁(标准差,5.4)。分娩时的平均孕周为38.6周。感染是最常见的孕产妇合并症(11.8%)。在分娩中,母亲在怀孕前、怀孕期间和怀孕后的药物配给率分别为63.2%、88.7%和82.9%。在关联儿童中,52.1%为男性,12.0%为早产,4.5%为低出生体重。主要先天性畸形的发生率为13.1%。持续参保儿童的特征与未持续参保儿童相似,但在出生后第一年的药物配给情况有所不同(62.9%对45.6%)。AM-PREGNANT的孕产妇和孕周分布均与美国国家估计数据相当。

结论

AM-PREGNANT是研究母婴药物安全性的宝贵队列。严格的入组标准确保了可靠的数据,将错误分类的风险降至最低。该队列是多国围产期药物流行病学研究的关键资源。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be5f/12361823/ad7ec9bb7651/fphar-16-1608403-g001.jpg

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