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

Completed

• Conditions: Analgesics Use During Breastfeeding and Concentrations in Human Mature Milk
• Interventions: Other: analgesic measure

• Registration Number: NCT01854411
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-15
• Primary Completion: 2014-05
• Study Completion: 2014-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
analgesic dose measure	analgesic measure	breastfeeding mother who will take analgesics

Primary Outcome Measures

Name	Time	Method
concentration of ibuprofene in human mature milk.	6 months
concentration of ketoprofene in human mature milk	6 months

Secondary Outcome Measures

Name	Time	Method
comparison between ibuprofene and ketoprofene concentrations in the human breastmilk	6 months	To compare the concentrations of ibuprofene and ketoprofene in the human breastmilk in correlation with the maturity

Trial Locations

Locations (1)

hopital Saint Antoire; 🇫🇷 Paris, France