Medications in Breast Milk: A Convenience Pharmacokinetic Study

NCT05099484 | Completed

• 1 other identifier: 2001678776
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Drug concentration in maternal blood

  Area under the plasma concentration versus time curve (AUC)

  study duration, typically up to 8 hours

Secondary Outcomes (2)

• Drug concentrations in breast milk at steady state

  study duration, typically up to 8 hours

• Relative infant dose- drug concentration in infant blood sample

  study duration, typically up to 8 hours

Interventions

The MedMilk study DRUG

This observational, pragmatic PK study will enroll lactating women who are taking medications that were prescribed by their treating medical provider or as an over-the-counter medication.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: breastfeeding female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 50 lactating women and 50 infants receiving mother's breast milk will participate in this study. Approximately 20 to 50 eligible lactating women per DOI will be enrolled. Overall, the investigators intend to assay approximately 15-20 drugs. Participants may be enrolled for one or more DOIs with a single consent.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected from the participating mother and infant (if enrolled into study). Timing of collection will be dependent on the reported half-life of the DOI. Typically, 3 mL of blood will be obtained prior to dosing and at approximately 15, 30, 60, and 90 minutes, and 2, 4, 6, and 8 hours after taking the drug for most medications. If a woman is able to provide breast milk via a pump then approximately 3-15 mL of foremilk and hindmilk from each breast will be pumped at baseline (prior to dosing of drug) then at approximately 2, 4, 6, and 8 hours, or sooner if the subject experiences discomfort due to her breasts becoming engorged

Study Officials

• David M Haas, MD

  Indiana Univesity School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 29, 2021
• Study Start: January 15, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

US (1)