Pregnancy and Mother–Infant Linked Studies

Pregnancy studies designed to achieve precision and scale for rare exposures and outcomes.

Our Approach

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

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:

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

What We Do

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.

Our studies have supported:

  • 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

Explore Publications

Explore our full publication library to learn more about the studies and methods that inform our work.