Pregnancy Study Designs

• A prospective, registry-based observational exposure cohort study
• Compares maternal, fetal, and infant outcomes of women exposed to the medicinal product of interest during pregnancy to an unexposed control population.

Detects and records:

• major and minor congenital malformations
• spontaneous abortions
• stillbirths
• elective terminations
• small for gestational age
• preterm birth
• other adverse pregnancy outcomes

Descriptive safety study that collects prospective and retrospective data in women exposed to the medicinal product of interest during pregnancy and/or lactation to assess:

• risk of pregnancy and maternal complications
• adverse effects on the developing fetus and neonate
• adverse effects on the infant

A pregnancy study using existing data (e.g. medical records, claims, registry data) for women exposed to the medicinal product of interest during pregnancy compared to an unexposed control population

Assesses:

• major congenital malformations
• spontaneous abortions
• stillbirth
• small for gestational age
• preterm birth

PK study to assess concentrations of the medicinal product of interest in breast milk and or infant plasma, as well as reported adverse effects on the breastfed infant.