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

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Analgesics Use During Breastfeeding and Concentrations in Human Mature Milk

Treatments

Other: analgesic measure

Study type

Observational

Funder types

Other

Identifiers

NCT01854411

NI09048

AOR10127

Details and patient eligibility

About

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

Full 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.

Enrollment

35 patients

Sex

Female

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

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