Pregnancy Related Clinical Trial
— MedMilkOfficial title:
Medications in Breast Milk: A Convenience Pharmacokinetic Study (The MedMilk Study)
Verified date | May 2024 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The benefits of breastfeeding and human milk consumption by infants has been clearly demonstrated. Benefits to the infant include reduction of infant and childhood diseases and allergies. Benefits to the woman include more rapid return to pre-pregnancy weight and reduced risk of health problems such as cardiovascular disease and diabetes in the future. Many women take medications as part of their standard of care and for multiple medical reasons in the postpartum period, when breastfeeding occurs. This creates a need for information about the transfer of drugs taken by a woman into breast milk, and ultimately, to the infant. Unfortunately, there are limited pharmacokinetic (PK) data on many of the medications commonly taken by lactating women. Additionally, there are little data on how the PK of drugs are impacted by lactation, and how this may vary from woman to woman or with time throughout lactation. Uptake of drugs into breast milk can vary due to a number of factors, including drug lipophilicity; molecular weight; drug half-life; active transport in breast epithelial cells; protein binding in milk and plasma; and lipid composition of breast milk. In silico and animal models can provide some information on transfer of drugs into breast milk, however, there are large gaps remaining in our knowledge of drug transfer into human milk. This information is crucial to better inform providers and patients about the transfer of those drugs to human breast milk. The purpose of this study is to characterize the PK of specific drugs of interest taken by lactating women as part of their standard of care. The drugs of interest (DOI) will be based on medical relevance and availability throughout the course of the study. The purpose of this study is to characterize the PK of medications taken by lactating women as part of their standard of care.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Women who are lactating, or who are admitted and/or consented for cesarean delivery and planning to breastfeed postpartum, AND are receiving at least one DOI per standard of care from their provider or through self-care (for over-the-counter medications). - Mothers who are at least 18 years of age and no more than 45 years of age Exclusion Criteria: - Induced lactation - Currently taking medication or supplements to increase milk production - Diagnosis of any significant chronic medical condition including (but not limited to) hepatitis, HIV, heart failure, liver or renal failure, or malabsorption conditions (e.g. celiac disease or inflammatory bowel disease) known to alter PK of DOI, unless the DOI is the indicated treatment for that disease - Alcohol use within 72 hours of study visit or planned PK blood draws - Illicit substance, other than THC, use within 1 week of study visit or planned PK blood draws |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Drug concentration in maternal blood | Area under the plasma concentration versus time curve (AUC) | study duration, typically up to 8 hours | |
Secondary | Drug concentrations in breast milk at steady state | Baseline and steady-state plasma concentrations of DOI in infants | study duration, typically up to 8 hours | |
Secondary | Relative infant dose- drug concentration in infant blood sample | calculation of relative infant dose | study duration, typically up to 8 hours |
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