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Enrollment
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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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This study seeks to evaluate the efficacy, side effect profile and acceptability of a medical abortion regimen with mifepristone and two doses of 800 mcg misoprostol buccally at 71-77 and 78-84 days of gestation to further expand the evidence base for the most effective regimens in the late first trimester of pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 71-77 days of gestational age | No Intervention | Pregnant people whose pregnancies are estimated to have a gestational age of 71-77 days. (Participants in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range). | |
| 78-84 days of gestational age | Experimental | Pregnant people whose pregnancies are estimated to have a gestational age of 78-84 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone + 2 doses of misoprostol 800 mcg | Drug | Will use a mifepristone-misoprostol regimen of: 200 mg mifepristone followed in 24-48 hours by a first dose of 800 µg misoprostol buccally and then in another 4 hours by a second dose of 800 µg misoprostol buccally. For buccal administration of misoprostol, participants will place 2 misoprostol tablets in each cheek and hold them for 20-30 minutes, after which they will swallow any remnants. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as determined by the proportion of successful abortions without aspiration or D&E for any reason | Proportion of women who achieve complete abortion with medication only and without aspiration or D&E | 7-36 days after initial visit |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who report each individual side effect | Side effects include diarrhea, nausea, vomiting, fever, chills | 7-14 days after initial visit |
| Proportion of complications experienced by participants that warrant visits to emergency room and/or hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hawaii | Hilo | Hawaii | 96720 | United States | ||
| University of Hawaii |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Complications could include abnormal bleeding, severe pain, retained tissue |
| 7-14 days after initial visit |
| Proportion of participants who determine method acceptable | Overall acceptability, time to complete abortion, bleeding, side effects, pain | 7-36 days after initial visit |
| Honolulu |
| Hawaii |
| 96822 |
| United States |
| Planned Parenthood North Central States | Saint Paul | Minnesota | 55114 | United States |
| Philadelphia Women's Center | Philadelphia | Pennsylvania | 19106 | United States |
| Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky | Federal Way | Washington | 98003 | United States |
| Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky | Tacoma | Washington | 98405 | United States |
| D011083 |
| Polycyclic Compounds |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |