Breast Feeding
Conditions
Keywords
cannabidiol, Breast milk, Breast-feeding, Breast-feed children, PK POP
Brief summary
Really few data published to date on the passage of CBD into breast milk. The investigators known that 17.5 percent of the French human being between 18 and 34 years old consume CBD and among this, nearly half are women. None official French data to say how many French breastfeeding mothers consume CBD. CBD is a legal, psychoactive but not psychoaddictive substance. CBD's pharmacokinetic and pharmacodynamics make us fear that CBD could easily go through mother's milk. No published data available on possible effect in breast-fed child, not even on possible biological passage in breast-fed child. The aim of his study is to evaluate the passage of CBD in blood and milk at different moments of the breastfeeding (mothers) and its possible found in the infants'urine.
Interventions
BIOLOGICALAssessing maternal and lactational plasma CBD uptake at different stages of breastfeeding
Determination of delta 9-tetrahydrocannabinol (THC) and its metabolites , and of cannabidiol and its metabolites in blood and breasts-milk by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Realization of THC/CBD ratio; qualitative research in mother's and breast-fed child's urine for the presence of cannabinoids (THC, CBD and its metabolites).
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
One group of sixty breastfeeding mothers with CBD's consumption Two subgroups: thirty subjects by group: * only CBD intake * CBD and others psychoactive substances
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women over 18 * Breastfeeding CBD user * Having given written informed consent
Exclusion criteria
* Women who do not understand French well * Women with a psychiatric or dual pathology that prevents proper participation in the study, * Women under protective supervision (guardianship/curatorship), * Women under court protection, * Women not affiliated to a social security scheme
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Theoretical dose of CBD received by the breastfed child over 24 hours | Day 2 postpartum | Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits. |
Secondary
| Measure | Time frame |
|---|---|
| Concentration of CBD in maternal blood | Day 2 postpartum |
| Concentration of CBD metabolites in maternal blood | Day 2 postpartum |
| Concentration of CBD in breast-milk | Day 2 postpartum |
| THC concentrations in mother's blood | Day 2 postpartum |
| THC concentrations in breast milk | Day 2 postpartum |
| Percentage of breastfeeding mother's with CBD metabolites in urine | Day 2 postpartum |
| THC/CBD ratio | Day 2 postpartum |
| Percentage of breastfeeding child with CBD in urine | Day 2 postpartum |
| Percentage of breastfeeding child with CBD metabolites in urine | Day 2 postpartum |
| impact of ethnicity | Day 2 postpartum |
| Percentage of breastfeeding mother's with CBD in urine | Day 2 postpartum |
| Percentage of breastfeeding mother's with THC in urine | Day 2 postpartum |
Countries
France
Contacts
CONTACTMarie-Philippe LEBOUCHARD-MAAKAROUN, Dr
CONTACTElodie POUGOUE
PRINCIPAL_INVESTIGATORMarie-Philippe LEBOUCHARD-MAAKAROUN, Dr
CHU Orleans
Outcome results
None listed