Methods |
"Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment" |
Participants |
"Inclusion Criteria:
Aged 21 years or older
Consented for elective medical abortion
Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound
Able and willing to receive text messages via phone
English speaking
Able and willing to give informed consent and agree to the study terms
Have assistance at home; no motor vehicle use while taking study medications
Exclusion Criteria:
Desires to continue pregnancy or currently breastfeeding
Lack of access to cell phone and texting capabilities
Prior participation in this study
Early pregnancy failure
Contraindications to the study medications: Marinol or marijuana derivatives, sesame oil, Ibuprofen
Contraindications to medical abortion with Mifepristone or Misoprostol
History of methadone, buprenorphine or heroin use within the last year
History of a seizure disorder
Used marijuana 5 or more days in the last week
History of any adverse effects associated with prior use of recreational or medical marijuana products, or sensitivity/allergy to Marinol"
|
Interventions |
"Drug: Dronabinol 5mg Cap Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain Other Name: Dronabinol
Subjects randomized to placebo and ibuprofen 800mg for pain" |
Outcomes |
"Maximum Self‐reported Pain Score on a Numeric Rating Scale [ Time Frame: 24 hours after misoprostol administration ] Women will text responds to surveys within 24 hours after misoprostol administration indicating their maximum self‐reported pain using an 11‐point numeric rating scale (NRS 0‐10) where 0=no pain and 10=worst possible pain." |
Notes |
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