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These pilot studies are designed as open label studies to investigate the acceptability of 200 mg mifepristone followed 24-48 hours later by either 1) 800 µg misoprostol administered buccally or 2) 800 µg misoprostol administered sublingually for medical abortion in gestations 78-84 days' LMP. They will be done consecutively.
Findings from the pilot studies will guide the development of a larger, multi-site study to investigate the efficacy of outpatient medical abortion regimens for women with gestations from 78 - 84 days LMP. In that end, the pilots seek to collect information on the acceptability of an outpatient medical abortion regimen of 200 mg oral mifepristone followed by either 800 mcg misoprostol delivered either buccally or sublingually safe acceptable? Women's rating of the tolerability of any side effects will also be documented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol at clinic | Experimental | Eligible women will receive 200 mg mifepristone to be administered at home or at the clinic and will receive either 800 µg misoprostol buccally (study 1) or 800 µg misoprostol sublingually (study 2) to self administer at home. Participants will be asked to return to the hospital 14 days later for a follow-up visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug |
| ||
| Mifepristone |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of women who have undergone a successful abortion | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Women's acceptability of the assigned method. | 2 weeks | |
| Side effects | Side effects include nausea, vomiting, pain, diarrhea, fever. Asked women to rank as none, mild, moderate, severe. Used an acceptability scale (Very Acceptable v. Acceptable v. Neutral v. Unacceptable v. Very unacceptable v. Don't know) to ascertain acceptability among women |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Jennifer Blum, MPH | Gynuity Health Projects | Principal Investigator |
| Nguyen Thu Nhu Ngoc, MD | Center for Research and Consultancy in Reproductive Health | Principal Investigator |
| Dina F Abbas | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hung Vuong Hospital | Ho Chi Minh City | Vietnam |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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|
| 48 hours |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |