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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01854411
First received: May 13, 2013
Last updated: September 2, 2013
Last verified: August 2013
  Purpose

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 Intervention
Analgesics Use During Breastfeeding and Concentrations in Human Mature Milk
Other: analgesic measure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ibuprofen and Ketoprofen Concentrations in Human Mature Milk. PK Study in Breastmilk AOR-10127 "Antalait" Study

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • concentration of ibuprofene in human mature milk. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • concentration of ketoprofene in human mature milk [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • comparison between ibuprofene and ketoprofene concentrations in the human breastmilk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 35
Study Start Date: September 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
analgesic dose measure
breastfeeding mother who will take analgesics
Other: analgesic measure
ibuprofen and ketoprofen measured into breast milk

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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01854411

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

Additional Information:
No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01854411     History of Changes
Other Study ID Numbers: NI09048, AOR10127
Study First Received: May 13, 2013
Last Updated: September 2, 2013
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014