Maternal Choline Supplementation and Cannabis Use During Pregnancy
This study is looking at whether a nutritional supplement called phosphatidylcholine can help with brain development in babies whose mothers used cannabis during pregnancy. Pregnant women who have used cannabis will receive either phosphatidylcholine or a placebo (an inactive substance) from about 16 weeks of pregnancy until birth. Researchers will then look at the baby's brain responses to sound at 1 month corrected age and their behaviors at 3 months corrected age. The study aims to enroll 140 women between 18 and 45 years old who are pregnant and have used cannabis during this pregnancy. Women with certain medical conditions or fetal anomalies cannot participate. The current status of the study is unclear.
- Study design
- This is an interventional study planning to enroll 140 women. Participants will be randomly assigned to receive either phosphatidylcholine or a placebo, and neither they nor the researchers will know which they are receiving (double-blind).
- What's involved
- Pregnant women will take capsules twice per day from approximately 16 weeks gestation through birth. Vital signs will be taken, and potential side effects will be assessed at each visit.
- Compensation
- Not stated in the trial record.
- Follow-up
- Babies' development will be assessed at 1 month corrected age and 3 months corrected age after birth.
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Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- M. Camille Hoffman, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
- Sharon Hunter, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado School of Medicine
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index3 months corrected age
The Orienting/Regulation Index is derived by adding the maternal rating of the infant's duration of attention, distractibility, soothability, cuddling, and smiling on the 91-item IBQ-r
- Auditory Sensory Gating (P50)1 month corrected age
Inhibition of the P50 cerebral auditory evoked response is collected during a paired stimulus auditory sensory gating paradigm