Summary

at La Jolla, California and other locations
study started
estimated completion
Christina Chambers

Description

Summary

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.

Details

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.

Keywords

Lactating Women on Select DOIBreastfed Infants of Mothers on Select DOIMetforminTranexamic AcidOxycodoneOndansetronDexetimideLabetalolCitalopramSertralineNifedipineClindamycinClindamycin palmitateClindamycin phosphateTranexamic acid (TXA)azithromycinescitalopram

Eligibility

You can join if…

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California-San Diego Medical Centernot yet accepting patients
    La JollaCalifornia92093United States
  • Loma Linda University Healthnot yet accepting patients
    Loma LindaCalifornia92354United States

Lead Scientist

  • Christina Chambers
    Dr. Chambers is a professor of pediatrics at University of California, San Diego and Director of Clinical Research for the Department of Pediatrics at UCSD and Rady Children's Hospital. She is a perinatal epidemiologist, whose research is focused on environmental exposures and pregnancy and child health outcomes, including birth defects.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kevin Watt
ID
NCT03511118
Study Type
Observational
Last Updated