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. 2022 May 13;2022(5):CD013525. doi: 10.1002/14651858.CD013525.pub2

NCT03139240.

Study name Opioid analgesia for MAB
Methods "Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:Double Blind
Primary Purpose: Treatment"
Participants "Inclusion Criteria:
  • Aged 18 years or older

  • Seeking elective medical abortion

  • In good health

  • Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound

  • Able and willing to receive text messages via phone

  • Literate in English

  • 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:
  • Lack of access to cell phone and texting capabilities

  • Early pregnancy failure

  • Contraindications to the study medications: Oxycodone, Ibuprofen

  • Contraindications to medical abortion with Mifepristone or Misoprostol

  • History of methadone or heroin use

  • Used alcohol in the past 24 hours

  • Used marijuana >4 times per week

  • Any opioid in the past 30 days

  • Using additional pain medications"

Interventions "Drug: Oxycodone 10mg oral
Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
Other: Placebo
Placebo given in addition to standard of care medications in women undergoing medical abortion"
Outcomes
  • "Overall Maximum Self‐reported Pain Score [ Time Frame: 24 hours after misoprostol administration ]


Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self‐reported pain score on an 11‐point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).
  • <7 Weeks of Gestation ‐ Maximum Self‐reported Pain Score [ Time Frame: 24 hours after misoprostol administration ]


Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self‐reported pain score on an 11‐point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).
  • 7‐10 Weeks Gestation ‐ Maximum Self‐reported Pain Score [ Time Frame: 24 hours after misoprostol administration ]


Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self‐reported pain score on an 11‐point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain)"
Starting date 01 May 2017
Contact information Oregon Health and Science University
Notes