The evidence gap in pregnancy safety

Traditional approaches to pregnancy safety research have fallen short. Fewer than 1% of clinical trials enroll pregnant women, and device safety is rarely evaluated in this population pre-approval. Meanwhile, existing data sources — registries, claims, and EHRs — are fragmented, slow, and incomplete.

Truveta Data offers access to the largest and most complete EHR dataset for pregnancy and pediatric research, with more than 1.4 million deterministically linked mother-child pairs. Researchers gain access to detailed, longitudinal data — including diagnoses, labs, procedures, vitals, clinical notes, imaging, and linked closed claims.

This briefing explores:

The evidence gap in drug and device safety for pregnant populations — and its downstream impact on child health

Why traditional data sources fall short for maternal-child research

How Truveta enables research from pre-pregnancy through early childhood with real-time, regulatory-grade data

Examples of research powered by complete, linked mother-child data — from medication safety to infant outcomes

The business impact across safety, HEOR, regulatory, and health equity domains

Download Real-world evidence for pregnancy and pediatrics Whitepaper