Ibuprofen and Ketoprofen Concentrations in Human Mature Milk. PK Study in Breastmilk AOR-10127 "Antalait" Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- concentration of ketoprofene in human mature milk
Study Overview
Brief Summary
The purpose of this study is to determine whether ibuprofen and ketoprofen do not enter into mature breastmilk that could allowed breastfeeding during a long time
Detailed Description
Analgesics are frequently used to prevent and treat pain and inflammatory disease.
Due to a lack of information on drug's human milk transfer, breastfeeding is sometimes contraindicated. Mothers are advised to either stop breastfeeding or if they don't, not to treat themselves. Since the fatal neonatal case with codeine during breastfeeding, analgesics are being reviewed. Ibuprofen seems to have the best benefit-risk ratio during the post-partum period. However there are no pharmacologic data about the use of ibuprofen during breastfeeding, after the colostrum phase.
This study aims to determine the relative infant dose (RID) of ibuprofen in human mature milk. Considering the increased interest in NSAIDs in light of the codeine case, this is an important information. It will help health practitioners when advising and treating breastfeeding women.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •breastfeeding women after the first week of delivery
- •breastfeeding women treated by ketoprofen or ibuprofen per os more than 24 hours
- •Written Informed Consent
Exclusion Criteria
- •breastfeeding women treated by naproxene
- •Curator or justice decision's
Arms & Interventions
analgesic dose measure
breastfeeding mother who will take analgesics
Intervention: analgesic measure (Other)
Outcomes
Primary Outcomes
concentration of ketoprofene in human mature milk
Time Frame: 6 months
concentration of ibuprofene in human mature milk.
Time Frame: 6 months
Secondary Outcomes
- comparison between ibuprofene and ketoprofene concentrations in the human breastmilk(6 months)