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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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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.
This study will include 152 women undergoing MAB. Women will be randomized to oxycodone 10mg oral versus placebo and stratified by gestational age (<7wks, 7-10wks). The primary outcome will be maximum reported pain score measured at 6-8 hours and 24 hours after misoprostol administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gestational age <7 weeks | Experimental | Women with a gestational age <7 weeks will be randomized to oxycodone 10mg oral vs placebo |
|
| Gestational age 7-10w0d | Experimental | Women with a gestational age 7-10w0d will be randomized to oxycodone 10mg oral vs placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone 10mg oral | Drug | Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | Beaverton | Oregon | 97005 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31764725 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxycodone: <7 Weeks of Gestation | Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion Women with a gestational age <7 weeks randomized to oxycodone 10mg oral |
| FG001 | Placebo: <7 Weeks Gestational Age | Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion Women with a gestational age <7 weeks and women with a gestational age 7-10w0d randomized to placebo |
| FG002 | Oxycodone: 7-10w0d Gestational Age | Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion Women with a gestational age 7-10w0d randomized to oxycodone 10mg oral |
| FG003 | Placebo: 7-10w0d Gestational Age | Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion Women with a gestational age <7 weeks and women with a gestational age 7-10w0d randomized to placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxycodone: <7 Weeks Gestational Age | Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion Women with a gestational age <7 weeks randomized to oxycodone 10mg oral |
| BG001 | Placebo: <7 Weeks Gestational Age |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Median | Full Range | units on a scale | 24 hours after misoprostol administration |
|
21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxycodone | Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion Women with a gestational age <7 weeks and women with a gestational age 7-10w0d randomized to oxycodone 10mg oral |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ongoing pregnancy | Reproductive system and breast disorders | Systematic Assessment | Resolved with standard treatment measures. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ob/Gyn Regulatory Specialist | Oregon Health & Science University | 5034940757 | mccrimmo@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2017 | Jun 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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Double Blind
| Placebo | Other | Placebo given in addition to standard of care medications in women undergoing medical abortion |
|
Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion Women with a gestational age <7 weeks randomized to placebo |
| BG002 | Oxycodone: 7-10w0d Weeks Gestational Age | Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion Women with a gestational age 7-10w0d randomized to oxycodone 10mg oral |
| BG003 | Placebo: 7-10w0d Weeks Gestational Age | Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion Women with a gestational age 7-10w0d randomized to placebo |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | <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). | Participants at <7 weeks of Gestation were assessed. Participants who were "lost to follow-up" were excluded from this analysis. | Posted | Median | Full Range | units on a scale | 24 hours after misoprostol administration |
|
|
|
| Primary | 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). | Participants at 7-10w0d of Gestation were assessed. Participants who were "lost to follow-up" were excluded from this analysis. | Posted | Median | Full Range | units on a scale | 24 hours after misoprostol administration |
|
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| 4 |
| 86 |
| EG001 | Placebo | Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion Women with a gestational age <7 weeks and women with a gestational age 7-10w0d randomized to placebo | 0 | 86 | 0 | 86 | 2 | 86 |
|
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| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |