U.S. flag An official website of the United States government
  1. Home
  2. For Consumers
  3. Women's Health
  4. Women's Health Topics
  5. Pregnancy Exposure Registries
  6. Pregnancy Exposure Registry Information
  1. Pregnancy Exposure Registries

Pregnancy Exposure Registry Information

From the FDA Office of Women's Health

Image
Image of pregnant Asian woman working on a laptop

Find a Pregnancy Exposure Registry

On this page:

Get involved

You can volunteer to join a pregnancy exposure registry (if one is open and enrolling) to share your experience with medicines or vaccines used while pregnant. Pregnancy exposure registries are research studies that collect information about the effect that prescription medicines taken, or vaccines received, may have on you and your developing fetus. Some pregnancy exposure registries also collect information about newborn babies for a period of time after birth. The information collected can help health care providers and others who are pregnant to learn more about the safety of medicines and vaccines used during pregnancy.

The pregnancy exposure registry will collect information about medicines you are already taking. It may also collect information about medicines you took or vaccines you received before you knew you were pregnant.

FDA has a list of ongoing pregnancy exposure registries on its website but does not run the pregnancy exposure registry studies. The companies that make medical products are usually in charge of the pregnancy exposure registry for their products. Sometimes, these research studies are run by other researchers.

How to volunteer for a pregnancy exposure registry

  1. Check the list of pregnancy exposure registries. Look for your medicine, vaccine, or medical condition.
  2. Get the website or phone number to speak with a pregnancy exposure registry team member to sign up. For some pregnancy registries, your health care provider, nurse, or midwife may need to sign you up.
  3. Ask what to expect when you sign up. Each pregnancy exposure registry has its own policies and procedures. When you contact the pregnancy exposure registry, ask about their policies such as:
    • How often will they contact you?
    • How will they keep your information private?
    • Who can you contact if you have questions?
    • How do you find out the results of the study when the pregnancy exposure registry ends?
    • Will they also want to collect information about your newborn baby?

Other information about your medicine or vaccine

If you do not see your medicine or vaccine on the list, ask your health care provider if it has a pregnancy exposure registry. There may not be a pregnancy exposure registry for that medicine or vaccine. You may find other information about your medicine at the links below:

Pregnant? FDA aims to improve medicine information

In 2015, FDA changed the pregnancy and breastfeeding labeling format for prescription medicines and vaccines. Since then, labeling for more than 2,000 prescription medicines and vaccines has been changed to the new format. These changes aim to improve presentation of pregnancy and breastfeeding-related information.

The revised labeling replaces the old format with more helpful information about a medicine’s or vaccine’s risks to the expectant mother and the developing fetus. The labeling also includes contact information for pregnancy exposure registry studies (if one is open and enrolling). These studies collect and maintain data on the effects of medicines and vaccines used by those who are pregnant.

Related links

 
Back to Top