Opioid Analgesia for MAB
1 other identifier
interventional
172
1 country
1
Brief Summary
Our primary objective will be to determine if a strong opioid, oxycodone, given at a dose recommended for severe pain in addition to ibuprofen decreases maximum pain scores compared to ibuprofen and placebo in women undergoing medical abortion (MAB). Results of this study will help future providers understand whether prescribing opioids are an important adjunct for pain control in women undergoing MAB.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedResults Posted
Study results publicly available
August 13, 2019
CompletedAugust 28, 2019
August 1, 2019
1.1 years
April 28, 2017
June 6, 2019
August 18, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Overall Maximum Self-reported Pain Score
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).
24 hours after misoprostol administration
<7 Weeks of Gestation - Maximum Self-reported Pain Score
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).
24 hours after misoprostol administration
7-10 Weeks Gestation - Maximum Self-reported Pain Score
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).
24 hours after misoprostol administration
Study Arms (2)
Gestational age <7 weeks
EXPERIMENTALWomen with a gestational age \<7 weeks will be randomized to oxycodone 10mg oral vs placebo
Gestational age 7-10w0d
EXPERIMENTALWomen with a gestational age 7-10w0d will be randomized to oxycodone 10mg oral vs placebo
Interventions
Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
Placebo given in addition to standard of care medications in women undergoing medical abortion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- Society of Family Planningcollaborator
Study Sites (1)
Site 1
Beaverton, Oregon, 97005, United States
Related Publications (1)
Colwill AC, Bayer LL, Bednarek P, Garg B, Jensen JT, Edelman AB. Opioid Analgesia for Medical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2019 Dec;134(6):1163-1170. doi: 10.1097/AOG.0000000000003576.
PMID: 31764725DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ob/Gyn Regulatory Specialist
- Organization
- Oregon Health & Science University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Instructor
Study Record Dates
First Submitted
April 28, 2017
First Posted
May 3, 2017
Study Start
May 1, 2017
Primary Completion
May 31, 2018
Study Completion
May 31, 2018
Last Updated
August 28, 2019
Results First Posted
August 13, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share