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Clinical Lactation Studies

From the FDA Office of Women's Health

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African American Woman nursing baby. Text: Learn more about clinical lactation studies

 Health Professionals  Find a Clinical Lactation Study Medicine and Pregnancy Download Clinical Lactation Study Factsheet PDF (4.24MB)

Are you breastfeeding and taking or considering taking a medical product? You are not alone. Many women need to use or receive medical products (such as prescription medicines and vaccines) while they are breastfeeding (lactating). 

For some medical products, studies have shown they are safe to use during breastfeeding. For other medical products, there may be less information about whether they are safe to use while breastfeeding. There are many benefits of breastfeeding for both you and your baby. Many women will need to decide whether to breastfeed while taking a medical product.

Clinical lactation studies are research studies that collect health information about the effects of medical products used while breastfeeding may have on you and/or your breast-fed baby. Some of these studies enroll healthy women who are not taking the medical product.

These studies may ask you to do some or all of the following:

  • Fill out a questionnaire about medical information concerning you and your baby
  • Track intake of the medical product you are using
  • Collect breast milk sample(s)
  • Donate sample(s) of your blood
  • Provide consent to collect sample(s) of your baby’s blood

You can volunteer to join a clinical lactation study if one is open and enrolling for the medical product you are receiving. The information collected can help health care providers and other women who are breastfeeding learn more about the safety of medical products used during breastfeeding. Learn more about how you can help.

Two women nursing babies. Text: Volunteer to enroll in a clinical lactation study.

New Knowledge and News on Women's Health (KNOWH) blog post: Understanding Clinical Lactation Studies: What They Are and Why They Matter

FDA Office of Women’s Health (OWH) is developing a new clinical lactation studies listings webpage designed to connect breastfeeding women with ongoing clinical lactation studies. The webpage will include a list of studies with the contact information to sign up to volunteer. 

If you are a study sponsor and would like your clinical lactation study added to this list, please email FDA at Registries@fda.hhs.gov.

How to sign up for a clinical lactation study?

FDA will update the list of clinical lactation studies database on a rolling basis. If you do not find a study for your medical product on the list, ask your health care provider if they can help you find a clinical lactation study.

Related links

General breastfeeding resources



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