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
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.
|Condition or disease
|First Submitted Date||December 14, 2015|
|Last Update Posted Date||December 21, 2017|
|Actual Start Date||November 01, 2016|
|Anticipated Completion Date||July 01, 2019|
|Actual Primary Completion Date||July 01, 2018|
|Results First Submitted Date||N/A|
|Received Results Disposit Date||N/A|
Current Primary Outcome Measures
Original Primary Outcome Measures
Current Secondary Outcome Measures
Duration of marijuana concentration in breast milk after postnatal use
[Time Frame: Breast milk collection 2-5 times weekly for 6 weeks]
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.
Frequency of marijuana use among postpartum women
[Time Frame: One time weekly for 6 weeks]
Using a weekly survey, investigators will collect patient-reported information about modes of marijuana use and frequency. This data will be correlated with THC concentrations and persistence in breast milk.
Original Secondary Outcome Measures
|Brief Title||Duration of Marijuana Concentration in Breast Milk- A Pilot Study|
|Official Title||Duration of Marijuana Concentration in Breast Milk- A Pilot Study|
|Target Follow-Up Duration|| N/A|
Retention: Samples Without DNA
Maternal breast milk, maternal urine, maternal plasma
|Sampling Method||Non-Probability Sample|
|Study Population||1. Patients who test positive for THC on a urine toxicology screening who intend to
breastfeed will be recruited within 72 hours of delivery.
2. Using direct-to-patient advertising, the investigators plan to advertise the study in
the UCH prenatal clinics, postpartum unit, and in the UCH and CHCO NICUs with an IRB
approved flyer. Patients who volunteer will submit a confidential urine sample to the
research staff when they present for delivery at UCH, or within 72 hours after
|Completion Date||July 01, 2019|
- 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
2. Volunteers: Patients of UCH prenatal OB clinics, postpartum unit, and in the UCH
and CHCO NICUs .
- 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).
|Age||18 Years to N/A|
|Accepts Healthy Volunteers||No|
|Listed Location Countries
|Other Study ID Numbers
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
|IPD Sharing Statement
|Responsible Party||, |
Erica Wymore, MD
Children's Hospital Colorado, University of Colorado Denver