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OpenTrials
Completed

NCT Number: NCT01854411

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

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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Key information

Conditions

Analgesics Use During Breastfeeding and Concentrations in Human Mature Milk

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

hopital Saint Antoire

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

analgesic measure

Other

ibuprofen and ketoprofen measured into breast milk

Primary outcomes

  1. concentration of ibuprofene in human mature milk.

    Time frame: 6 months

  2. concentration of ketoprofene in human mature milk

    Time frame: 6 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Ibuprofen and Ketoprofen Concentrations in Human Mature Milk. PK Study in Breastmilk AOR-10127 "Antalait" Study

Acronym: ANTALAIT

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 15, 2013
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.