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| ID | Type | Description | Link |
|---|---|---|---|
| AOR10127 |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| analgesic dose measure | breastfeeding mother who will take analgesics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| analgesic measure | Other | ibuprofen and ketoprofen measured into breast milk |
|
| Measure | Description | Time Frame |
|---|---|---|
| concentration of ibuprofene in human mature milk. | 6 months | |
| concentration of ketoprofene in human mature milk | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Lactarium, Maternal care, Consultant of Lactation
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| Name | Affiliation | Role |
|---|---|---|
| virginie rigourd, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| hopital Saint Antoire | Paris | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24695355 | Result | Rigourd V, de Villepin B, Amirouche A, Bruneau A, Seraissol P, Florent A, Urien S, Magny JF, Serreau R. Ibuprofen concentrations in human mature milk--first data about pharmacokinetics study in breast milk with AOR-10127 "Antalait" study. Ther Drug Monit. 2014 Oct;36(5):590-6. doi: 10.1097/FTD.0000000000000058. |
| Label | URL |
|---|---|
| Medic-Al network to help the women and investigators to receive specialize information's about breastfeeding and medications | View source |
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human breast milk