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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
| Family Planning Associates Medical Group, LTD | OTHER |
| Planned Parenthood of Greater New York | OTHER |
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This trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. The primary study outcome is pain.
This trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. The primary study outcome is pain. Secondary objectives include comparing the regimens for the total amount of ibuprofen taken, use of other analgesics, vaginal bleeding, adverse events, successful completion of abortion, overall satisfaction with the abortion procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic | Active Comparator | Ibuprofen |
|
| Prophylactic | Active Comparator | Ibuprofen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | Ibuprofen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 11-point Visual Analog Scale for Pain | Participant pain was assessed using an 11-point Visual Analog Scale for Pain. Scores ranged from 0 (no pain) to 10 (worst pain possible) | 1-2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
- Have contraindications to ibuprofen
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Raymond, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Planning Associates Medical Group | Chicago | Illinois | 60630 | United States | ||
| Planned Parenthood of New York City, Inc. |
| 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. | |
| 23921857 | Derived | Raymond EG, Weaver MA, Louie KS, Dean G, Porsch L, Lichtenberg ES, Ali R, Arnesen M. Prophylactic compared with therapeutic ibuprofen analgesia in first-trimester medical abortion: a randomized controlled trial. Obstet Gynecol. 2013 Sep;122(3):558-64. doi: 10.1097/AOG.0b013e31829d5a33. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prophylactic | Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period. |
| FG001 | Therapeutic | Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Inclusive of participants who provided follow-up data only
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| ID | Title | Description |
|---|---|---|
| BG000 | Prophylactic | Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period. |
| BG001 | Therapeutic |
| 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 | 11-point Visual Analog Scale for Pain | Participant pain was assessed using an 11-point Visual Analog Scale for Pain. Scores ranged from 0 (no pain) to 10 (worst pain possible) | Posted | Mean | Standard Deviation | units on a scale | 1-2 weeks |
|
1-2 weeks (beginning the day of enrollment to the day the woman returned for follow-up after which her study participation concluded)
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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 | Prophylactic | Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Raymond | Gynuity Health Projects | 2124481230 | eraymond@gynuity.org |
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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 |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| New York |
| New York |
| 10012 |
| United States |
Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 123 |
| 0 |
| 123 |
| EG001 | Therapeutic | Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period. | 0 | 127 | 0 | 127 |
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