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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01854411
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Analgesics Use During Breastfeeding and Concentrations in Human Mature Milk Other: analgesic measure

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 Design

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ibuprofen and Ketoprofen Concentrations in Human Mature Milk. PK Study in Breastmilk AOR-10127 "Antalait" Study
Study Start Date : September 2011
Primary Completion Date : May 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
analgesic dose measure
breastfeeding mother who will take analgesics
Other: analgesic measure
ibuprofen and ketoprofen measured into breast milk


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
human breast milk

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Lactarium, Maternal care, Consultant of Lactation
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854411


Locations
France
hopital Saint Antoire
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: virginie rigourd, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information

Additional Information:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01854411     History of Changes
Other Study ID Numbers: NI09048
AOR10127
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Analgesics
Ibuprofene
Ketoprofene
Breastmilk
Relative Infant Dose
Theoric Infant Dose

Additional relevant MeSH terms:
Ibuprofen
Ketoprofen
Analgesics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action