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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-11-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Analgesics Use During Breastfeeding and Concentrations in Human Mature Milk

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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analgesic dose measure

breastfeeding mother who will take analgesics

analgesic measure

Intervention Type OTHER

ibuprofen and ketoprofen measured into breast milk

Interventions

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analgesic measure

ibuprofen and ketoprofen measured into breast milk

Intervention Type OTHER

Eligibility Criteria

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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