RWE 101 – Pregnancy Registries

A pregnancy registry is a type of real-world evidence collection system that collects data from pregnant women who have been exposed to a particular medication, vaccine, or medical intervention during pregnancy. The purpose of a pregnancy registry is to gather information about the safety and effectiveness of these exposures in pregnant women and their offspring.

Pregnancy registries are important because pregnant women are often excluded from clinical trials due to safety concerns, which can limit the amount of data available about the safety and effectiveness of medications, vaccines, and medical inyterventions during pregnancy. By collecting data from pregnant women who have been exposed to these agents, pregnancy registries can provide valuable information to healthcare providers and patients to help guide treatment decisions during pregnancy.

A pregnancy registry typically collects information about the mother’s health status, the medication or medical intervention being studied, and pregnancy outcomes such as miscarriage, stillbirth, preterm birth, and birth defects. The data collected can be used to identify potential safety signals or adverse effects associated with the medication or medical intervention, and to evaluate the overall safety and effectiveness of the treatment in pregnant women.

In summary, pregnancy registries are an important tool in real-world evidence collection for understanding the safety and effectiveness of medications, vaccines, and medical interventions during pregnancy. By gathering data from pregnant women who have been exposed to these agents, pregnancy registries can provide valuable information to healthcare providers and patients to help guide treatment decisions and improve the health outcomes of both mother and child.

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