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

Overview

Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying. We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of drug that is consumed by breastfed infants.

Detailed description

The purpose of this study is to understand if the study drugs of interest are found in breastmilk and how much; to estimate the amount of drug that is consumed by breastfed infants and what effect this may have on infants; and to share what we learn with other researchers. The study drugs of interest have Food and Drug Administration (FDA) approval, but there is little or no information about the amount of drug found in the breastmilk of mothers who take them; the amount of drug that may be transferred to their infant's through breastmilk; or the effects this transfer may have on their infants. During this study we will ask to collect breastmilk and blood from mothers, and blood from infants, to measure the amount of study drug of interest in these body fluids. Results from this study will help researchers better understand how much of the study drug of interest is in your blood and breastmilk, and how much of the study drug of interest may be in your infant's blood because of breastfeeding.

Interventions

• Drug Tranexamic acid (TXA)
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Drug labetalol
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Drug metformin
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Drug nifedipine
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Drug clindamycin
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Drug oxycodone
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Drug azithromycin
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Drug escitalopram
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Drug sertraline
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Drug ondansetron
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Primary outcome measures

• M/P ratio [Time frame: Until the infant becomes 180 days of age]
• DID [Time frame: Until the infant becomes 180 days of age]
• RID [Time frame: Until the infant becomes 180 days of age]
• I/M ratio [Time frame: Until the infant becomes 180 days of age]

Secondary outcome measures (4)

• Safety profile of commonly used drugs in infants exposed to drugs in breastmilk [Time frame: Until the infant becomes 180 days of age]
• AE [Time frame: Up until 180 days of age]
• SAE [Time frame: Up until 180 days of age]
• ESI [Time frame: Until the infant becomes 180 days of age]

Eligibility criteria

Inclusion criteria

• Lactating women who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk.
• Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior to any study-related procedures. Lactating women who are not legal adults and their breastfed infants may be enrolled if they assent to participate in the study and consent is obtained from their legal guardian according to local IRB/REB/IEC guidelines.

Exclusion criteria

• Any concomitant condition which, in the opinion of the physicians providing patient care or the principal investigator conducting the study, would preclude a subject's participation in the study.
• Known pregnancy during PK sampling.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

United States · 20 centers

• University of California-San Diego Medical Center — La Jolla
• Loma Linda University Health — Loma Linda
• Northwestern University — Chicago
• Ann and Robert H. Lurie Childrens Hospital of Chicago — Chicago
• Indiana University Health — Indianapolis
• University of Iowa Hospitals and Clinics — Iowa City
• Children's Hospital and Clinics - Minneapolis — Minneapolis
• University of New Mexico, Health Sciences Center — Albuquerque
• … and 12 more centers

Canada · 2 centers

• Lawson Health Research Institute — London
• Centre Hospitalier Universitaire Sainte-Justine — Montreal

Publications

• Job KM, Dallmann A, Parry S, Saade G, Haas DM, Hughes B, Berens P, Chen JY, Fu C, Humphrey K, Hornik C, Balevic S, Zimmerman K, Watt K. Development of a Generic Physiologically-Based Pharmacokinetic Model for Lactation and Prediction of Maternal and Infant Exposure to Ondansetron via Breast Milk. Clin Pharmacol Ther. 2022 May;111(5):1111-1120. doi: 10.1002/cpt.2530. Epub 2022 Mar 5. PMID 35076931

Identifiers

NCT: NCT03511118 · Pro00088919 · HHSN275201000003I/27500051

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗