Pregnancy and Mother–Infant Linked Studies

Studies of medication and vaccine use during pregnancy present unique scientific and operational challenges.

Many exposures and outcomes are rare, and accurate linkage between maternal and infant records is essential to fully understand safety and effectiveness.

Our team has extensive experience designing and executing pregnancy studies using real-world data, including mother-infant linkage across large, diverse populations. By combining robust epidemiologic methods with scalable, multi-site infrastructure, we generate evidence that is relevant for regulatory and clinical decision-making.

Why Our Approach Matters

Achieving sufficient power while maintaining the ability for chart-confirmation is a central challenge in real-world pregnancy research. Individual data sources often lack the size needed to evaluate rare exposures or uncommon but clinically important outcomes.

We address this by applying a distributed, multi-site approach that enables us to work with multiple data partners domestically and internationally.

This approach allows us to:

Evaluate rare exposures and outcomes with adequate statistical power
Maintain data in their source environments while applying standardized analytic methods
Support studies with chart confirmation and validation for claims-based outcomes
Generate timely evidence across large networks

What We Do

We design and conduct pregnancy and mother–infant linked studies to support:

Medication and vaccine safety in pregnancy: assessing maternal, fetal, and infant outcomes
Maternal and infant outcome assessment: including pregnancy outcomes (e.g., stillbirth, spontaneous abortion, preterm birth) major congenital malformations, and neonatal outcomes
Mother–infant data linkage: developing and applying methods to accurately link records across data sources
Studies of rare exposures and outcomes: leveraging multi-site data to achieve necessary scale
Regulatory and post-approval studies: supporting evidence generation in populations often underrepresented in trials

Highlighted Studies and Publications

Interim Safety of RSVpreF Vaccination During Pregnancy

Authors: Michnick AI, MacDonald SC, Cosgrove A, Adimadhyam S, Zhang F, Petrone AB, Round KE, Gandhi S, Koram N, Anastasiou OE, Rubino H, Lino MM, Djibo DA, Kuntz JL, Love SM, McMahill-Walraven CN, Palmsten K, Wentz AE, Maro JC, Platt R, Andrade SE

Published in Journal of the American Medical Association on February 2, 2026

Postmarketing commitment safety study of HZ/suto evaluate pregnancy exposures and outcomes in immunodeficient or immunosuppressed women between 18 and 49 years of age

Harvard Pilgrim Health Care Institute, CVS Health, Carelon Research, Optum Epidemiology, GlaxoSmithKline

A Post-Authorization Safety Study to Evaluate the Safety of Abrocitinib Exposure During Pregnancy in United States Healthcare Databases

Harvard Pilgrim Health Care Institute, CVS Health, Carelon Research, HealthPartners Institute, Humana HealthCare Research, Pfizer, Inc.