Pregnancy RelatedMedMilkNCT05099484
Medications in Breast Milk: A Convenience Pharmacokinetic Study
An observational study of Pregnancy Related, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- The MedMilk study
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medications in Breast Milk: A Convenience Pharmacokinetic Study (The MedMilk Study)
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.
Read the detailed description
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. Study investigators will not be prescribing or recommending medication use as part of this study. Feasibility of the study is enhanced by a partnership with The Milk Bank, which will refer women identified as taking medications to study investigators. Subjects will also be recruited from Eskenazi Health and IU Health. Blood and breast milk samples will be collected from lactating women prior to administration of a dose of drug and at varying time points after dosing to characterize maternal and infant plasma PK and transfer of drug into breast milk.
Another phase of the study will evaluate plasma concentrations of DOIs in breastfed infants whose mothers are already taking the medications. Infant blood samples will be obtained by heel stick or venipuncture from enrolled infants in order to determine the concentration of the drug in the infant's blood. The design of this study allows for the evaluation of the use of drugs in lactating women with minimal risk to participants. As blood draws and expressed milk samples are obtained often during clinical care or daily postpartum life, this study is not greater than minimal risk. Lactating women taking a DOI will have biospecimens collected from maternal breast milk and maternal blood. Breast milk will be collected from pumped or manually expressed samples.
- Conditions
- Pregnancy Related
- Being tested
- The MedMilk study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The MedMilk studyDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug concentration in maternal blood
Area under the plasma concentration versus time curve (AUC)
Measured: study duration, typically up to 8 hours
Secondary outcomes (2)
Drug concentrations in breast milk at steady state
Baseline and steady-state plasma concentrations of DOI in infants
Measured: study duration, typically up to 8 hours
Relative infant dose- drug concentration in infant blood sample
calculation of relative infant dose
Measured: study duration, typically up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start15 Jan 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Haas, Indiana University
- Investigators
- David M Haas, MD, Principal investigator, Indiana Univesity School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099484
- Sponsor's protocol ID
- 2001678776
- Acronym
- MedMilk
- Status last verified
- May 2024
- First submitted
- 5 Oct 2021
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medications in Breast Milk: A Convenience Pharmacokinetic Study (The MedMilk Study)
- ClinicalTrials.gov ID
- NCT05099484
- Acronym / sponsor ID
- MedMilk / 2001678776
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Study investigators will not be prescribing or recommending medication use as part of this study. Feasibility of the study is enhanced by a partnership with The Milk Bank, which will refer women identified as taking medications to study investigators. Subjects will also be recruited from Eskenazi Health and IU Health. Blood and breast milk samples will be collected from lactating women prior to administration of a dose of drug and at varying time points after dosing to characterize maternal and infant plasma PK and transfer of drug into breast milk.
Another phase of the study will evaluate plasma concentrations of DOIs in breastfed infants whose mothers are already taking the medications. Infant blood samples will be obtained by heel stick or venipuncture from enrolled infants in order to determine the concentration of the drug in the infant's blood. The design of this study allows for the evaluation of the use of drugs in lactating women with minimal risk to participants. As blood draws and expressed milk samples are obtained often during clinical care or daily postpartum life, this study is not greater than minimal risk. Lactating women taking a DOI will have biospecimens collected from maternal breast milk and maternal blood. Breast milk will be collected from pumped or manually expressed samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The MedMilk studyThis 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. | Drug | – |
Primary outcome
Drug concentration in maternal blood
Time frame: study duration, typically up to 8 hours
Area under the plasma concentration versus time curve (AUC)
2 secondary outcomes
Drug concentrations in breast milk at steady state
Time frame: study duration, typically up to 8 hours
Relative infant dose- drug concentration in infant blood sample
Time frame: study duration, typically up to 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Haas, MD principal investigator
Indiana Univesity School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug concentration in maternal blood (time frame: study duration, typically up to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.