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This double blinded, placebo-controlled randomized trial will compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800 mcg doses of buccal misoprostol three hours apart. All drugs are administered AT home by the participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mifepristone+misoprostol | Other | 200 mg mifepristone + 800 mcg buccal misoprostol |
|
| buccal misoprostol | Experimental | 2 doses of 800 mcg buccal misoprostol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medical abortion | Drug | pregnancy termination with drugs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of women with a complete abortion using study drug alone without recourse to surgical intervention | Number of participants with a complete abortion after treatment without recourse to surgical intervention as a measure of efficacy of the study regimens | one week from initial treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of women who indicate that the side effects of buccal misoprostol, administered either alone or in combination with mifepristone, is acceptable in Tunisia and Vietnam | Proportion of women who report the side effects after their treatment to be acceptable as a measure of acceptability with the buccal misoprostol route (with and without mifepristone) | one week from initial treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Rabta Maternity Hospital | Tunis | Tunisia | ||||
| Hung Vuong Hospital |
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| Evaluate whether women administering buccal misoprostol have a complete abortion with study drug and experience any adverse events, at a rate that is similar to other routes of misoprostol administration | To assess the rate of complete uterine evacuation with study drugs alone and rate of any adverse events among participants after use of buccal misoprostol (alone or with mifepristone)as a measure of its utility in early medical abortion compared to other regimens | one week from initial treatment |
| Measuring the proportion of women who report their medical abortion procedure to be acceptable in Tunisia and Vietnam | Proportion of participants reporting that they found the medical abortion regimen assigned to them to be acceptable | one week from initial treatment |
| Determining whether women can take both the mifepristone and misoprostol at home on their own by assessing protocol compliance | Proportion of women who report taking mifepristone and misoprostol at home on their own as instructed as a measure of compliance and feasibility of a protocol with at home administration of study drugs | one week from initial treatment |
| Ho Chi Minh City |
| Vietnam |