Prescription medication use and baseline health status of women with live-birth deliveries in a national data network

Abstract

Background: 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.

Objective: 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.

Study design: 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.

Results: 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.

Conclusion: 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.

Keywords: claims data; mother-infant–linked data; perinatal medication use; postmarketing surveillance.