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FDA - Pregnancy Exposure Registries - March 23, 2019

Resources » Food and Drug Administration (FDA) » Pregnancy Exposure Registries

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General Information about Pregnancy Exposure Registries
  • About 50% of all U.S. pregnancies are unplanned.
  • Many women enter pregnancy with medical conditions that require medical treatment.
  • New medical problems may develop or old ones may worsen due to pregnancy.
  • It is common for pregnant women to take medication during the critical period of fetal development because
    • The woman is unaware of her pregnancy.
    • It may be medically necessary to continue treatment throughout pregnancy.

In response to these facts, FDA began requiring some pharmaceutical manufacturers to conduct pregnancy exposure registries. The results of these studies will provide pregnant women and their health care providers' better understanding of drug effects on fetal health. FDA/OWH developed a master directory of pregnancy registries to aid pregnant women who are taking medications to participate in these important studies.

What is a pregnancy exposure registry?

FDA defines a pregnancy exposure registry as a prospective observational study that collects information on women who take medicines and vaccines during pregnancy.

Enrollment requires that the health of the baby be unknown to reduce bias. Data collected on babies born to women taking a particular medicine are compared with babies of women not taking the medicine. These studies provide important information the effect medicines have on fetal development

How can you participate in a pregnancy exposure registry?

Contact the pregnancy exposure registry you are interested in to find out what you need to do to sign up.

Some registries may require you to enroll through your health care provider (doctor, nurse, or pharmacist).

What should you expect when you participate?

Participation requires a few interviews during and after your pregnancy. The information collected during these interviews, as well as the fact of your participation, will be kept confidential.

The outcome of your pregnancy--and that of the other participants in the study--will be analyzed periodically. The pregnancy registry contact can tell you if reports of these analyses are available and how to obtain them.

Please Note: All medication use should be discussed with your doctor. Please speak with a health-care provider who knows you, your condition, and your medicine before making any decision about the use of medical products during pregnancy.

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