Ibuprofen and Ketoprofen Concentrations in Human Mature Milk. PK Study in Breastmilk AOR-10127 "Antalait" Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- concentration of ketoprofene in human mature milk
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breastfeeding women after the first week of delivery
- •breastfeeding women treated by ketoprofen or ibuprofen per os more than 24 hours
- •Written Informed Consent
排除标准
- •breastfeeding women treated by naproxene
- •Curator or justice decision's
研究组 & 干预措施
analgesic dose measure
breastfeeding mother who will take analgesics
干预措施: analgesic measure (Other)
结局指标
主要结局
concentration of ketoprofene in human mature milk
时间窗: 6 months
concentration of ibuprofene in human mature milk.
时间窗: 6 months
次要结局
- comparison between ibuprofene and ketoprofene concentrations in the human breastmilk(6 months)