Suarez Elizabeth A, Haug Nicole, Hansbury Aaron, Stojanovic Danijela, Corey Catherine
Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA (Dr Suarez, Ms Haug, and Mr Hansbury).
Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA (Dr Suarez, Ms Haug, and Mr Hansbury).
Am J Obstet Gynecol MFM. 2022 Jan;4(1):100512. doi: 10.1016/j.ajogmf.2021.100512. Epub 2021 Oct 14.
The US Food and Drug Administration increasingly uses administrative databases to conduct surveillance of medications used during pregnancy. To assess adverse fetal effects, administrative records must be linked between the mother and infant. The Sentinel Initiative's Mother-Infant Linkage Table provides a large cohort of linked deliveries from national, regional, and public insurance claims in the United States for the US Food and Drug Administration to conduct surveillance.
This study aimed to describe baseline health conditions and prescription medication use during pregnancy in cohorts of women with a live-birth delivery linked and not linked to an infant.
Live-birth deliveries in women aged 10 to 54 years with at least 391 days of medical and drug coverage before delivery were identified in the Sentinel Mother-Infant Linkage Table from 2000 to 2019. Two cohorts were created for analysis: deliveries linked to infant records (linked deliveries, n=2,320,805) and deliveries unable to be linked to an infant (not-linked deliveries, n=504,785). Baseline health conditions, pregnancy history, healthcare utilization, and pregnancy conditions were defined using International Classification of Diseases, Ninth Revision, and International Classification of Diseases, Tenth Revision, diagnosis and procedure codes. Medication exposure was identified in a 90-day prepregnancy period and in each trimester.
Few notable differences were observed between the linked and not-linked deliveries except for maternal age and preterm birth; the not-linked cohort was 3.4 years younger on average and more likely to have a preterm delivery. At baseline among the linked deliveries, the most common conditions were depression and anxiety (5.2% each), acquired hypothyroidism (5.0%), pain conditions (3.9%), and asthma (2.8%). Among linked deliveries, 6.9% had evidence of gestational diabetes mellitus, 3.9% had gestational hypertension, and 4.5% had preeclampsia or eclampsia. The most commonly used medications during pregnancy in the linked deliveries were antibacterials (41.6%) and antiemetics (21.5%); similar medication use patterns were observed in the not-linked cohort. Age trends were observed for some medication groups; anti-infectives, pain medications, and antiemetics were more common in younger mothers, whereas endocrine medications were more common in older mothers.
Similarities between the linked and not-linked cohorts suggested that the ability to link mother and infant records is not influenced by maternal health status. In the linked cohort, the prevalence of specific pregnancy complications and medication use were similar to previously reported national estimates. Some baseline comorbidities, such as obesity and smoking, may be underestimated in the Sentinel Mother-Infant Linkage.
美国食品药品监督管理局越来越多地使用行政数据库对孕期用药进行监测。为评估胎儿不良影响，必须将母亲和婴儿的行政记录相链接。哨兵计划的母婴链接表提供了一大群来自美国国家、地区和公共保险索赔的链接分娩数据，供美国食品药品监督管理局进行监测。
本研究旨在描述有活产分娩且与婴儿记录相链接和未相链接的女性队列在孕期的基线健康状况和处方药使用情况。
在哨兵母婴链接表中识别出2000年至2019年期间年龄在10至54岁、分娩前至少有391天医疗和药物覆盖的活产分娩女性。创建两个队列进行分析：与婴儿记录相链接的分娩（链接分娩，n = 2,320,805）和无法与婴儿相链接的分娩（未链接分娩，n = 504,785）。使用国际疾病分类第九版和国际疾病分类第十版的诊断和程序编码定义基线健康状况、妊娠史、医疗保健利用情况和妊娠状况。在孕前90天和每个孕期识别药物暴露情况。
除产妇年龄和早产外，在链接分娩和未链接分娩之间未观察到明显差异；未链接队列平均年轻3.4岁，早产的可能性更大。在链接分娩的基线时，最常见的疾病是抑郁症和焦虑症（各占5.2%）、获得性甲状腺功能减退症（5.0%）、疼痛性疾病（3.9%）和哮喘（2.8%）。在链接分娩中，6.9%有妊娠期糖尿病的证据，3.9%有妊娠期高血压，4.5%有先兆子痫或子痫。链接分娩中孕期最常用的药物是抗菌药物（41.6%）和止吐药（21.5%）；在未链接队列中观察到类似的用药模式。在一些药物组中观察到年龄趋势；抗感染药物、止痛药和止吐药在年轻母亲中更常见，而内分泌药物在年长母亲中更常见。
链接队列和未链接队列之间的相似性表明，母婴记录的链接能力不受母亲健康状况的影响。在链接队列中，特定妊娠并发症的患病率和药物使用情况与先前报告的全国估计值相似。哨兵母婴链接中可能低估了一些基线合并症，如肥胖和吸烟。
