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This randomized trial will compare the rates of ongoing pregnancy, safety/side effects and acceptability of two medical abortion regimens that are commonly used in Latin America. The first regimen will involve three 800 mcg doses of misoprostol taken buccally in three hour intervals; the second will involve three 800 mcg doses of misoprostol taken sublingually in three hour intervals. This study will also aim to assess the feasibility and acceptability of a semi-quantitative pregnancy test (SQPT) for at-home follow-up in both settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buccal | Experimental | Women randomized to receive three 800 mcg doses of misoprostol taken buccally in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up. |
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| Sublingual | Experimental | Women randomized to receive three 800 mcg doses of misoprostol taken sublingually in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | Women will receive three 800 mcg doses of misoprostol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Ongoing pregnancy rates | The study will assess and compare the rates of ongoing pregnancy for the two medical abortion regimens at 1-2 week follow up. | 1-2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of side effects and complications as a measure of safety/ side effects | Assess and compare the safety/side effects of two regimens of misoprostol alone for early pregnancy termination. | 1-2 weeks |
| Reported acceptability and satisfaction with misoprostol regimen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy R Sheldon, PhD | Gynuity Health Projects | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Health Clinic | La Paz | Pedro Domingo Murillo | Bolivia | |||
| Reproductive Health Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30831103 | Derived | Sheldon WR, Durocher J, Dzuba IG, Sayette H, Martin R, Velasco MC, Winikoff B. Early abortion with buccal versus sublingual misoprostol alone: a multicenter, randomized trial. Contraception. 2019 May;99(5):272-277. doi: 10.1016/j.contraception.2019.02.002. Epub 2019 Mar 1. |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Semi-quantitative pregnancy test | Device | All women will be given a semi-quantitative pregnancy test (SQPT) for at-home follow-up. |
|
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The study will also assess and compare satisfaction and acceptability of each medical abortion regimen as rated by the women. |
| 1-2 weeks |
| Usability of SQPT as measured by women's ability to assess success of medical abortion procedure at home | The study will assess women's ability to use the SQPT effectively for at-home assessment of the success of the medical abortion procedure. | 1-2 weeks |
| Self-reported acceptability and satisfaction with SQPT as a means of at-home follow up | The study will also assess the acceptability of the test as a means for at-home follow-up after medical abortion as rated by the women. The woman will answer questions about whether she found the SQPT easy to use an acceptable for at-home follow up. | 1-2 weeks |
| Quito |
| Ecuador |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |