Study of Analgesics Drug and Human Milk Transfer in Mature Milk, to Avoid Breastfeeding Cessation Without Scientific Probes (ANTALAIT)
|Analgesics Use During Breastfeeding and Concentrations in Human Mature Milk||Other: analgesic measure|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Ibuprofen and Ketoprofen Concentrations in Human Mature Milk. PK Study in Breastmilk AOR-10127 "Antalait" Study|
- concentration of ibuprofene in human mature milk. [ Time Frame: 6 months ]
- concentration of ketoprofene in human mature milk [ Time Frame: 6 months ]
- comparison between ibuprofene and ketoprofene concentrations in the human breastmilk [ Time Frame: 6 months ]To compare the concentrations of ibuprofene and ketoprofene in the human breastmilk in correlation with the maturity
Biospecimen Retention: Samples Without DNA
|Study Start Date:||September 2011|
|Study Completion Date:||November 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
analgesic dose measure
breastfeeding mother who will take analgesics
Other: analgesic measure
ibuprofen and ketoprofen measured into breast milk
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01854411
|hopital Saint Antoire|
|Paris, France, 75012|
|Study Chair:||virginie rigourd, MD, PhD||Assistance Publique - Hôpitaux de Paris|