Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Medical abortion has been associated with significant pain. The objective of this trial is to determine whether one dose of pregabalin 300 mg, given during medical abortion in addition to the standard of care analgesics, will decrease experienced pain. Investigators will perform a randomized, double-blinded, placebo-controlled trial. Participant pain levels and side effects will be assessed at multiple time points, along with a measure of satisfaction.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Pregabalin 300 mg capsule (over encapsulated to maintain blinding) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Pain Score Over Study Period | reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain | Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Ibuprofen 800mg Tablets Used | summed number of tablets used by each participant over the 72 hour study period | Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours) |
| Number of Oxycodone/Acetominophen Tablets (5/325mg) Used |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Options Center | Honolulu | Hawaii | 96826 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35553047 | Derived | Reynolds-Wright JJ, Woldetsadik MA, Morroni C, Cameron S. Pain management for medical abortion before 14 weeks' gestation. Cochrane Database Syst Rev. 2022 May 13;5(5):CD013525. doi: 10.1002/14651858.CD013525.pub2. | |
| 30095762 | Derived | Friedlander EB, Soon R, Salcedo J, Davis J, Tschann M, Kaneshiro B. Prophylactic Pregabalin to Decrease Pain During Medication Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):612-618. doi: 10.1097/AOG.0000000000002787. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding) |
| FG001 | Placebo | Placebo: Matching placebo capsule with excipient to match Pregabalin |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding) |
| BG001 | Placebo | Placebo: Matching placebo capsule with excipient to match Pregabalin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Maximum Pain Score Over Study Period | reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain | Posted | Mean | Standard Deviation | units on a scale | Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Family Planning Department | University of Hawaii | 808-983-6000 | hawaiimedab@gmail.com |
Not provided
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Matching placebo capsule with excipient to match Pregabalin |
|
summed number of tablets used by each participant over the 72 hour study period
| Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours) |
| Number of Participants Ever Experiencing Different Symptoms During Abortion | A participant was included once if they ever reported a symptom during the 72 hour study period, not reflective of how long the symptom lasted. These were all commonly reported side effects during previous research on medication abortions and commonly reported side effects of pregabalin, so they were not included as adverse events. | Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours) |
| Satisfaction With Analgesia | 5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied) | Asked at time point of 24 hours |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Ibuprofen 800mg Tablets Used | summed number of tablets used by each participant over the 72 hour study period | Posted | Median | Inter-Quartile Range | tablets | Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours) |
|
|
|
| Secondary | Number of Oxycodone/Acetominophen Tablets (5/325mg) Used | summed number of tablets used by each participant over the 72 hour study period | Posted | Median | Inter-Quartile Range | tablets | Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours) |
|
|
|
| Secondary | Number of Participants Ever Experiencing Different Symptoms During Abortion | A participant was included once if they ever reported a symptom during the 72 hour study period, not reflective of how long the symptom lasted. These were all commonly reported side effects during previous research on medication abortions and commonly reported side effects of pregabalin, so they were not included as adverse events. | Posted | Number | participants | Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours) |
|
|
|
| Secondary | Satisfaction With Analgesia | 5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied) | Posted | Count of Participants | Participants | Asked at time point of 24 hours |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Placebo | Placebo: Matching placebo capsule with excipient to match Pregabalin | 0 | 52 | 0 | 52 | 0 | 52 |
Not provided
Not provided
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Sleepiness |
|
| Dizziness |
|
| Headache |
|
| Blurred Vision |
|
| Diarrhea |
|
| Constipation |
|
| Dry Mouth |
|
| Neutral |
|
| Satisfied |
|
| Very satisfied |
|
| No response |
|