Study of Analgesics Drug and Human Milk Transfer in Mature Milk, to Avoid Breastfeeding Cessation Without Scientific Probes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ibuprofen and Ketoprofen Concentrations in Human Mature Milk. PK Study in Breastmilk AOR-10127 Antalait Study

Conditions
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Analgesics Use During Breastfeeding and Concentrations in Human Mature Milk

Intervention / Treatment
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* Other: analgesic measure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| analgesic dose measure<br>breastfeeding mother who will take analgesics | Other: analgesic measure<br>* ibuprofen and ketoprofen measured into breast milk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of ibuprofene in human mature milk. |  | 6 months | 
| concentration of ketoprofene in human mature milk |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison between ibuprofene and ketoprofene concentrations in the human breastmilk | To compare the concentrations of ibuprofene and ketoprofene in the human breastmilk in correlation with the maturity | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesics, Ibuprofene, Ketoprofene, Breastmilk, Relative Infant Dose, Theoric Infant Dose