Duration of Marijuana Concentration in Breast Milk- A Pilot Study
Status: | Recruiting |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/6/2019 |
Start Date: | November 2016 |
End Date: | July 2019 |
Contact: | Erica Wymore, MD |
Email: | erica.wymore@childrenscolorado.org |
Phone: | (303) 520-4770 |
Legalization of marijuana in Colorado for both medicinal and recreational purposes has led to
a perception of its safety, which has not been well studied in pregnant or lactating women.
The psychoactive component of marijuana, delta-9-tetrahydrocannabinol (THC) is lipophilic and
therefore presumed to be secreted into breast milk. Additionally, the difference between
modes of consumption (ie. smoked vs. edible) has not been well described in regards to THC
concentration in breast milk. The purpose of this small pilot study is to describe the
presence and duration of THC expression in breast milk among women who have evidence of THC
exposure at the time of labor and delivery or within 72 hours of delivery. The researchers
hypothesize that women with positive urine drug screen for THC within 72 hours of delivery
may excrete THC in breast milk for a predicted period of time, and therefore the aim of this
project is to determine timing to safely return to breastfeeding to decrease infant exposure
to THC.
The specific aims are to determine in women who test positive for THC at delivery:
1. Determine length of time THC and metabolites are detected in breast milk of mothers who
have a positive urine drug screen at the time of presentation for labor and delivery or
within 72 hours of delivery.
2. Determine length of time THC and metabolites are detected in breast milk of mothers with
postnatal exposure of either ingested or inhaled marijuana, to inform recommendations on
when to safely return to breastfeeding.
3. Describe modes of marijuana consumption in women presenting for delivery and correlate
with THC concentrations and persistence in breast milk.
a perception of its safety, which has not been well studied in pregnant or lactating women.
The psychoactive component of marijuana, delta-9-tetrahydrocannabinol (THC) is lipophilic and
therefore presumed to be secreted into breast milk. Additionally, the difference between
modes of consumption (ie. smoked vs. edible) has not been well described in regards to THC
concentration in breast milk. The purpose of this small pilot study is to describe the
presence and duration of THC expression in breast milk among women who have evidence of THC
exposure at the time of labor and delivery or within 72 hours of delivery. The researchers
hypothesize that women with positive urine drug screen for THC within 72 hours of delivery
may excrete THC in breast milk for a predicted period of time, and therefore the aim of this
project is to determine timing to safely return to breastfeeding to decrease infant exposure
to THC.
The specific aims are to determine in women who test positive for THC at delivery:
1. Determine length of time THC and metabolites are detected in breast milk of mothers who
have a positive urine drug screen at the time of presentation for labor and delivery or
within 72 hours of delivery.
2. Determine length of time THC and metabolites are detected in breast milk of mothers with
postnatal exposure of either ingested or inhaled marijuana, to inform recommendations on
when to safely return to breastfeeding.
3. Describe modes of marijuana consumption in women presenting for delivery and correlate
with THC concentrations and persistence in breast milk.
This prospective, observational pilot study will identify women within 72 hours of delivery
who have a positive urine drug screen for THC and who intend to breastfeed. Eligibility will
not be dependent upon the disposition of the infant, either discharged shortly after birth or
infants with NICU admission. The study will last six weeks from the time of enrollment.
Mothers who consent to participate will complete an in-person survey on marijuana use and
exposure during pregnancy at study entry and weekly surveys of current marijuana use. Samples
of maternal breast milk, maternal urine, and infant urine will be collected at least three
times, but no more than five times during the week (Monday - Friday) during infant
hospitalization, dependent on maternal availability. If the infant is discharged from the
hospital, visits will occur twice weekly during out-patient clinic visits. The presence of
marijuana will be measured by THC concentrations in maternal breast milk, maternal urine and
maternal plasma, collected by research staff at each visit. the investigators will ask
mothers to refrain from feeding their baby their breast milk for at least 2 weeks after last
marijuana exposure, which currently is the minimum time period recommended by lactation
consultants in UCH and CHCO Neonatal Intensive Care Units (NICU). If a NICU admitted infant
is medically stable to tolerate enteral feedings, they are given feedings either by mouth or
by nasogastric feeding tubes, of either expressed breast milk, donor breast milk, or formula.
The researchers current practice for infants admitted to the NICU is to offer donor breast to
infants whose mothers cannot provide their own breast milk, for numerous reasons. Mothers of
infants who are not in the NICU would be encouraged to pump breast milk and dump, for 2 weeks
after last THC exposure while using formula until returning to breastfeeding. As this issue
is commonly encountered in our clinical practice, the investigators find that many mothers
are committed to providing safe feedings to their infants after given education regarding
concerns of THC impact on infant development. The time point to safely return to breast milk
following THC exposure is unknown, and is a primary aim of this study.
There are numerous documented benefits to breast milk, especially in preterm infants however
sufficient literature exists to question the safety of THC's effects on the developing brain
which may also be particularly susceptible in prematurity. Due to these unknown and
understudied but highly concerning effects, The researchers faculty Neonatology practice has
agreed to the consensus of refraining from knowingly administering breast milk from mothers
actively using THC. Exemptions do occur in certain clinical settings. If this occurs during a
mother's study enrollment, subsequent samples would be marked appropriately and the
analytical data will be carefully examined.
who have a positive urine drug screen for THC and who intend to breastfeed. Eligibility will
not be dependent upon the disposition of the infant, either discharged shortly after birth or
infants with NICU admission. The study will last six weeks from the time of enrollment.
Mothers who consent to participate will complete an in-person survey on marijuana use and
exposure during pregnancy at study entry and weekly surveys of current marijuana use. Samples
of maternal breast milk, maternal urine, and infant urine will be collected at least three
times, but no more than five times during the week (Monday - Friday) during infant
hospitalization, dependent on maternal availability. If the infant is discharged from the
hospital, visits will occur twice weekly during out-patient clinic visits. The presence of
marijuana will be measured by THC concentrations in maternal breast milk, maternal urine and
maternal plasma, collected by research staff at each visit. the investigators will ask
mothers to refrain from feeding their baby their breast milk for at least 2 weeks after last
marijuana exposure, which currently is the minimum time period recommended by lactation
consultants in UCH and CHCO Neonatal Intensive Care Units (NICU). If a NICU admitted infant
is medically stable to tolerate enteral feedings, they are given feedings either by mouth or
by nasogastric feeding tubes, of either expressed breast milk, donor breast milk, or formula.
The researchers current practice for infants admitted to the NICU is to offer donor breast to
infants whose mothers cannot provide their own breast milk, for numerous reasons. Mothers of
infants who are not in the NICU would be encouraged to pump breast milk and dump, for 2 weeks
after last THC exposure while using formula until returning to breastfeeding. As this issue
is commonly encountered in our clinical practice, the investigators find that many mothers
are committed to providing safe feedings to their infants after given education regarding
concerns of THC impact on infant development. The time point to safely return to breast milk
following THC exposure is unknown, and is a primary aim of this study.
There are numerous documented benefits to breast milk, especially in preterm infants however
sufficient literature exists to question the safety of THC's effects on the developing brain
which may also be particularly susceptible in prematurity. Due to these unknown and
understudied but highly concerning effects, The researchers faculty Neonatology practice has
agreed to the consensus of refraining from knowingly administering breast milk from mothers
actively using THC. Exemptions do occur in certain clinical settings. If this occurs during a
mother's study enrollment, subsequent samples would be marked appropriately and the
analytical data will be carefully examined.
Inclusion Criteria:
- Eligible participants will be identified in two ways:
1. Standard of care urine toxicology screening at the time of delivery: Women who
test positive for THC on a urine toxicology screening who intend to breastfeed
will be recruited within 72 hours of delivery at University of Colorado Hospital
(UCH) and mothers whose infants are admitted to Children's Hospital Colorado
(CHCO) NICU.
2. Volunteers: Patients of UCH prenatal OB clinics, postpartum unit, and in the UCH
and CHCO NICUs .
Exclusion Criteria:
- Mothers who do not intend to breastfeed; mothers less than 18 years of age; mothers
who have positive urine drug for other illicit drugs (cocaine, methamphetamines).
We found this trial at
2
sites
13123 E 16th Ave
Aurora, Colorado 80045
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Erica Wymore, MD
Phone: 720-777-9514
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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13001 E. 17th Pl
Aurora, Colorado 80045
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Erica Wymore, MD
Phone: 720-777-9514
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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