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This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 64-70 days' gestational age | Experimental | Women whose pregnancies are estimated to have a gestational age of 64-70 days |
|
| 57-63 days' gestational age | No Intervention | Women whose pregnancies are estimated to have a gestational age of 57-63 days. (Women in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone and misoprostol | Drug | 200 mg oral mifepristone 800 mcg buccal misoprostol or 400 mcg sublingual misoprostol 24-48 hours after mifepristone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion | 7-36 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of individual side effects experienced by participants | 7-14 days | |
| Proportion of women who determined method acceptable (i.e., overall acceptability of method, time to abortion completion, bleeding, side effects, and pain) | 7-14 days |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yael Swica, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Hillary Bracken, PhD | Gynuity Health Projects | Principal Investigator |
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Presidential Women's Center | West Palm Beach | Florida | 33407 | United States | ||
| Family Planning Associates Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23090524 | Derived | Winikoff B, Dzuba IG, Chong E, Goldberg AB, Lichtenberg ES, Ball C, Dean G, Sacks D, Crowden WA, Swica Y. Extending outpatient medical abortion services through 70 days of gestational age. Obstet Gynecol. 2012 Nov;120(5):1070-6. doi: 10.1097/aog.0b013e31826c315f. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 14, 2013 | |
| Reset | Apr 30, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2013 | Apr 30, 2013 |
| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began | 7-14 days |
| Average number of missed days of work or school due to the abortion procedure | 7-14 days |
| Chicago |
| Illinois |
| 60630 |
| United States |
| Planned Parenthood League of Massachusetts | Boston | Massachusetts | 02215 | United States |
| Planned Parenthood, Minnesota, North Dakota, South Dakota | Saint Paul | Minnesota | 55116 | United States |
| Planned Parenthood of New York City | New York | New York | 10012 | United States |
| Planned Parenthood, Central Texas | Waco | Texas | 76710 | United States |
| Zhordania Institute of Human Reproduction | Tbilisi | Georgia |
| Government Medical College (GMC) | Nagpur | India |
| Naval Nursing Home | Solapur | India |
| La Rabta Maternity Hospital | Tunis | Tunisia |
| Central District Maternity House | Odesa | Ukraine |
| Maternity Hospital No.2 | Simferopol | Ukraine |
| 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 |