Understanding Clinical Lactation Studies – What They are and Why They Matter
Knowledge and News on Women’s Health (KNOWH) blog from FDA Office of Women’s Health
Find a Clinical Lactation Study Download Clinical Lactation Study Factsheet PDF (4.24MB)
The benefits of breastfeeding for both breastfeeding mothers and babies receiving breast milk are well known. To better understand the benefits and safety of using medical products (such as prescription medicines and vaccines) on the breastfeeding woman and/or the breastfed baby, researchers rely on data from clinical lactation studies along with other relevant data. Learn more about clinical lactation studies and the important role they play. If you are breastfeeding and using a medical product, consider volunteering to enroll in a study.
What are clinical lactation studies?
Clinical lactation studies are research studies that collect health information about the effects medical products used while breastfeeding may have on you and/or your breastfed baby. Some of these studies enroll healthy participants who are not using the medical product. The information collected can help health care providers and women who are breastfeeding learn more about the safety of medical products used during breastfeeding.
Why are clinical lactation studies important?
Many women need to use medical products while they are breastfeeding and wonder about the safety of those medical products for their breastfed baby. As a result, some women must make difficult decisions about whether to continue breastfeeding while using medical products.
For some medical products, studies have shown they are safe to use during breastfeeding. For others, there may be less information about whether they are safe to use while breastfeeding. Clinical lactation studies are a way for researchers to learn more about the safety of medical products used while breastfeeding. By enrolling in a clinical lactation study, you can help other breastfeeding women and health care providers learn more about the safety of medical products taken while breastfeeding may have on you and/or your breastfed baby. The safety information collected from these studies can also be used to update the medical product’s labeling.
Does FDA conduct clinical lactation studies?
FDA does not conduct clinical lactation studies. The companies that make the medical product conduct clinical lactation studies for their products. Sometimes, these research studies are run by other researchers. FDA does not endorse any clinical lactation study and is not responsible for the conduct of clinical lactation studies.
What happens when you sign up for a clinical lactation study?
Each study has its own procedures about how they contact you and what you need to do to participate. Depending on the study, the following are examples of what the study may ask of you:
- 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
Where can you find more information on clinical lactation studies?
The FDA Office of Women’s Health (OWH) is developing a new listings webpage to help connect breastfeeding women and health professionals with ongoing clinical lactation studies. The webpage will include a list of studies and the contact information for breastfeeding women interested in volunteering. You can search for a study using the medical product name or medical condition.
How can a breastfeeding woman participate in a clinical lactation study?
Check the list of studies webpage (COMING SOON!) and look for your medical product or medical condition. Get the enrollment information to contact the study team to sign up. For some studies, your health care provider may need to sign you up. Make sure you ask what to expect when you sign up.
What if there is no clinical lactation study for the medical product I use?
There isn’t a clinical lactation study for every medical product. If you do not find a study for the medical product you are using on the list, ask your health care provider if they can help you find a clinical lactation study.
How can health care providers support breastfeeding women in enrolling in clinical lactation studies?
Are you a health care provider? Help your patients volunteer to enroll in a clinical lactation study. The information collected supplements the safety information for medical products used while breastfeeding and may be used to update the medical product’s safety labeling.
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.
Learn more about clinical lactation studies by visiting: www.fda.gov/clinicallactationstudies.