Analgesics Use During Breastfeeding and Concentrations in Human Mature MilkANTALAITNCT01854411
Study of Analgesics Drug and Human Milk Transfer in Mature Milk, to Avoid Breastfeeding Cessation Without Scientific Probes
An observational study of Analgesics Use During Breastfeeding and Concentrations in Human Mature Milk, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Analgesics Use During Breastfeeding and Concentrations in Human Mature Milk
- What is being tested?
- analgesic measure
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Lactarium, Maternal care, Consultant of Lactation
Who may be able to join
- breastfeeding women after the first week of delivery
- breastfeeding women treated by ketoprofen or ibuprofen per os more than 24 hours
- Written Informed Consent
Who cannot join
- breastfeeding women treated by naproxene
- Curator or justice decision's
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ibuprofen and Ketoprofen Concentrations in Human Mature Milk. PK Study in Breastmilk AOR-10127 "Antalait" Study
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
Read the 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.
- Being tested
- analgesic measure
- Keywords
- Analgesics, Ibuprofene, Ketoprofene, Breastmilk, Relative Infant Dose, Theoric Infant Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analgesic measureOther
ibuprofen and ketoprofen measured into breast milk
| Study group | Role | What they receive |
|---|---|---|
| analgesic dose measure | breastfeeding mother who will take analgesics Receives: Other: analgesic measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of ibuprofene in human mature milk.
Measured: 6 months
concentration of ketoprofene in human mature milk
Measured: 6 months
Secondary outcomes (1)
comparison between ibuprofene and ketoprofene concentrations in the human breastmilk
To compare the concentrations of ibuprofene and ketoprofene in the human breastmilk in correlation with the maturity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startSep 2011
- Primary completionMay 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesics Use During Breastfeeding and Concentrations in Human Mature MilkStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- virginie rigourd, MD, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854411
- Sponsor's protocol ID
- NI09048
- Other IDs
- AOR10127
- Acronym
- ANTALAIT
- Status last verified
- Mar 2026
- First submitted
- 13 May 2013
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Rigourd V, de Villepin B, Amirouche A, Bruneau A, Seraissol P, Florent A, Urien S, Magny JF, Serreau R. Ibuprofen concentrations in human mature milk--first data about pharmacokinetics study in breast milk with AOR-10127 "Antalait" study. Ther Drug Monit. 2014 Oct;36(5):590-6. doi: 10.1097/FTD.0000000000000058.
PubMed 24695355
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen and Ketoprofen Concentrations in Human Mature Milk. PK Study in Breastmilk AOR-10127 "Antalait" Study
- ClinicalTrials.gov ID
- NCT01854411
- Acronym / sponsor ID
- ANTALAIT / NI09048
- Keywords
- Analgesics, Ibuprofene, Ketoprofene, Breastmilk, Relative Infant Dose, Theoric Infant Dose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Sep 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| analgesic dose measure | – | Other: analgesic measurebreastfeeding mother who will take analgesics |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Lactarium, Maternal care, Consultant of Lactation
Key inclusion criteria (3 listed)
- breastfeeding women after the first week of delivery
- breastfeeding women treated by ketoprofen or ibuprofen per os more than 24 hours
- Written Informed Consent
Key exclusion criteria (2 listed)
- breastfeeding women treated by naproxene
- Curator or justice decision's
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analgesic measureibuprofen and ketoprofen measured into breast milk | Other | analgesic dose measure |
Primary outcome
concentration of ibuprofene in human mature milk.
Time frame: 6 months
concentration of ketoprofene in human mature milk
Time frame: 6 months
1 secondary outcome
comparison between ibuprofene and ketoprofene concentrations in the human breastmilk
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Results publication: PubMed 24695355Rigourd V, de Villepin B, Amirouche A, Bruneau A, Seraissol P, Florent A, Urien S, Magny JF, Serreau R. Ibuprofen concentrations in human mature milk--first data about pharmacokinetics study in breast milk with AOR-10127 "Antalait" study. Ther Drug Monit. 2014 Oct;36(5):590-6. doi: 10.1097/FTD.0000000000000058.
- Medic-Al network to help the women and investigators to receive specialize information's about breastfeeding and medicationsLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
virginie rigourd, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesics Use During Breastfeeding and Concentrations in Human Mature Milk, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of ibuprofene in human mature milk. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01854411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.