(SLC-020) Characterization of Mothers in the Sentinel Distributed Database Mother-Infant Linkage Table

Background: The US Food and Drug Administration's Sentinel Distributed Database (SDD) includes claims data from different healthcare organizations, some linking mother-infant data (MIL tables), allowing the study of prenatal, mother, and infant characteristics and drug use before, during, and after pregnancy.

Objectives: To characterize the demographics, health characteristics, and drug utilization of mothers with singleton live births (linked and unlinked to an infant record in the MIL table) and non-live birth outcomes in the SDD.

Methods: We characterized data from six Sentinel Data Partners that populate the MIL table (five national/regional health plans and Medicaid) from 2000 to 2024. A claims-based algorithm identified pregnancies with live or non-live birth outcomes (spontaneous abortions, induced abortions, ectopic pregnancies, trophoblastic disease, and stillbirths). Live birth deliveries may be linked or unlinked to an infant record. Eligible females (ages 10-54) had continuous enrollment from 90 days before pregnancy to delivery. Maternal age at delivery and comorbidities were assessed 90 days before to 90 days after pregnancy start. Drug use, including suspected teratogens, was assessed 90 days before pregnancy to delivery.

Results: Of the total live birth deliveries, 78% were linked (5,349,432) and 22% unlinked (1,514,740). Non-live birth outcomes totaled 3,264,447, with 55.6% spontaneous abortions, 30.5% induced abortions, 9.7% ectopic pregnancies, 2.4% trophoblastic disease, and 1.8% stillbirths.

The mean maternal age across live birth deliveries was 29 years (standard deviation 5.2). Of live birth deliveries, 28% were cesarean and 10% preterm; the most common comorbidities were anxiety (7.3%) and depression (6.5%).

In linked live birth deliveries, the most used drug classes 90 days before pregnancy were anti-infectives (24%) and endocrine therapies (13%), with fluctuating use across trimesters. Use of analgesics/anti-inflammatories and central nervous system agents decreased over trimesters. Anti-infectives were the most common drugs in mothers aged 10-29 across linked live birth deliveries, biologics in those aged 30-39, and endocrine therapies in those aged 45-54. Suspected teratogens were rarely used, with fluconazole (an antifungal) being the most common (2.2- 2.8% across trimesters).

Conclusions: We characterized over 6.7 million live births and 3.2 million non-live birth outcomes among SDD enrollees and assessed the real-world uptake of several drug classes and suspected teratogens across pregnancy trimesters. This data, particularly for 5.3 million deliveries linked to an infant record, offers valuable opportunities to study medication exposure and its impact on maternal, prenatal, and infant health outcomes.