RecruitingOBSERVATIONAL

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

This study aims to understand how common medicines used by breastfeeding mothers pass into breast milk and affect their babies. Many mothers need to take prescription drugs while breastfeeding, but there's often not much information about how these drugs might affect their infants. We're looking for breastfeeding mothers who are already taking certain medications as part of their usual medical care. We will measure the amount of drug in mothers' blood and breast milk, as well as in their babies' blood. The information we gather will help doctors and researchers make better, safer choices for mothers and their breastfed infants in the future, ensuring they receive the best care without unnecessary worry.

At a glance

Status

Recruiting

Sponsor

Duke University

Enrolment target

1,600

Start

04 Oct 2018

Estimated completion

31 Jul 2028

Lactating Women on Select DOI Breastfed Infants of Mothers on Select DOI

What is this study about?

This study is all about understanding what happens when breastfeeding mothers take commonly prescribed medicines. When a mum takes medication, a tiny amount can sometimes pass into her breast milk. We don't always know exactly how much of a particular drug gets into the milk, or how much of that might then be taken in by the baby, or what effect it might have. This study aims to fill those gaps in our knowledge, helping us make sure breastfeeding mums and their babies are as safe as possible.

We're inviting mothers who are already taking one of a specific list of medicines as part of their ordinary medical care. These aren't new or experimental drugs; they are medicines that doctors regularly prescribe. However, there isn't much detailed information about them when it comes to breastfeeding. By taking part, you'll be helping us learn more about how these drugs behave, which is really important for future mothers and their healthcare providers.

The main goal is to measure how much of the medicine is in a mother's blood and her breast milk, and also to estimate how much might be in the baby's blood. This information will help researchers understand the levels of drugs babies might be exposed to through breastfeeding. Sharing what we learn with other medical experts will lead to better guidance and more peace of mind for mothers everywhere.

Key takeaways

Help us understand how common medicines affect breastfed babies.
You must be a breastfeeding mum, up to 6 months postpartum.
Your baby must also be no older than 6 months and breastfed.
You need to be taking one of a specific list of medicines already.
Participation involves giving small blood and breast milk samples.
This research helps make breastfeeding safer for future mums and babies.

Who may be eligible?

To be able to join this study, you need to be a mother who is currently breastfeeding. Your baby must also be receiving your breast milk. Both you and your baby should be no more than about 6 months old (180 days postpartum for mum, and 180 days old for baby).

Another important requirement is that you must already be taking at least one of the specific medicines we are studying as part of your normal medical care. You'll also need to sign a consent form, which explains everything about the study in detail, before you do anything related to the research. If you are under 18, you can still take part if you agree, and your parent or legal guardian gives their permission.

There are also a few reasons why you might not be able to join. For example, if a doctor thinks that taking part in the study would not be good for your health, or your baby's health, then you wouldn't be able to participate. Also, if you find out you are pregnant during the study's blood sampling times, you would not be able to continue.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you currently breastfeeding?
Is your baby 6 months old or younger and receiving your breast milk?
Are you currently taking one of the study medicines as prescribed by your doctor?
Are you able to provide consent (or if under 18, is a guardian able to consent with your agreement)?
Do you have no other health conditions that a doctor thinks would make taking part unsafe?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be asked to provide some samples. This will involve giving small blood samples from yourself and your baby. We will also ask you to provide samples of your breast milk. These samples are taken to measure the levels of the medicine you are taking in your body, your breast milk, and your baby's body.

We don't expect you to change any of your medications; you'll continue to take your prescribed medicine exactly as your own doctor has told you to. The study involves a few visits over a short period to collect these samples. The total duration of your active participation will depend on the specific drug and sampling schedule, but it's designed to be as convenient as possible. You won't receive new medication from the study.

Potential risks and benefits

Taking part in this study may offer the benefit of contributing to important scientific knowledge that will help other breastfeeding mothers and their babies in the future. You will also learn about the specific levels of the drug in your breast milk and your baby's blood, which can be reassuring. Potential risks are generally minimal, mainly involving the discomfort or bruising from blood draws, for both you and your baby. However, all procedures are carried out by trained professionals with great care. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (22)

University of California-San Diego Medical Center
Verified postcode
La Jolla, United States· Recruiting
Loma Linda University Health
Verified postcode
Loma Linda, United States· Recruiting
Northwestern University
Verified postcode
Chicago, United States· Completed
Ann and Robert H. Lurie Childrens Hospital of Chicago
Verified postcode
Chicago, United States· Recruiting
Indiana University Health
Verified postcode
Indianapolis, United States· Completed
University of Iowa Hospitals and Clinics
Verified postcode
Iowa City, United States· Active not recruiting
Children's Hospital and Clinics - Minneapolis
Verified postcode
Minneapolis, United States· Recruiting
University of New Mexico, Health Sciences Center
Verified postcode
Albuquerque, United States· Completed
University of North Carolina Hospital
Verified postcode
Chapel Hill, United States· Completed
Duke University Maternal and Fetal Medicine
Verified postcode
Durham, United States· Recruiting
Oregon Health & Science University
Verified postcode
Portland, United States· Recruiting
Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine
Verified postcode
Philadelphia, United States· Completed

Common questions

Will I have to stop breastfeeding or change my medication?

No, you will not have to stop breastfeeding or change your medication. You will continue taking your medicine as prescribed by your own doctor.

Is this study testing new medicines?

No, this study is looking at common medicines that mothers are already prescribed by their doctors, not new or experimental drugs.

Will my baby be given any extra medicine?

No, your baby will not be given any extra medicine as part of this study.

What happens to my samples after they are collected?

Your blood and breast milk samples will be carefully analysed to measure drug levels, and the results will be used for research to help other families.

Who will know I am taking part?

Your privacy is very important. All your information will be kept confidential, meaning only the study team will see it, and your name will not be linked to the results.

How to find out more

Emily Forgey

emily.forgey@duke.edu 919-660-8720 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.