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The effectiveness of antibiotic treatment at reducing post-abortion infection is unclear. The experiences of women prescribed routine antibiotics after medical abortion is missing from the existing evidence. This study seeks to add to the literature evidence of the side effects associated with antibiotic treatment that women experience and their adherence to prescribed regimens.
Medical abortion (MA) consists of administering medication, typically a combination of mifepristone and misoprostol, to induce an abortion without any invasive procedures. Early first trimester MA is effective1, highly acceptable to women, and safe. The risk of infection following medical abortion is small, at less than 1%. In rare circumstances, pelvic infection with clostridia bacteria following medical abortion has resulted in death. Since 2000, when mifepristone was registered in the United States, 8 such deaths have been recorded in the US.
Following the publication of case reports of four clostridium-associated deaths after medical abortion in 2005, the reproductive health community reacted swiftly. Medical abortion protocols were altered in an effort to curb these drastic and rapidly fatal infections. Antibiotic treatment, typically a seven-day course of doxycycline, has become widespread in the United States.
The effectiveness of antibiotic treatment at reducing post-abortion infection is unclear. The experiences of women prescribed routine antibiotics after medical abortion is missing from the existing evidence. This study seeks to add to the literature evidence of the side effects associated with antibiotic treatment that women experience and their adherence to prescribed regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxy | Women who are prescribed a seven-day regimen of doxycycline following medical abortion | ||
| No Doxy | Women who are not prescribed antibiotics following medical abortion |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence rates of nausea | Compare the incidence rates of nausea between women who are prescribed a seven-day regimen of doxycycline to women who are not prescribed antibiotics following medical abortion | 7-14 days following medical abortion |
| adherence | Document the self-reported adherence to antibiotic regimens following medical abortion | 7-14 days following medical abortion |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea rates | Compare the rates of nausea between women who take at least one doxycycline pill to women who do not take any doxycycline following medical abortion | 7-14 days following medical abortion |
| Non-nausea side effects |
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Inclusion Criteria:
Exclusion Criteria:
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This study will enroll 610 women. Women will be recruited from 5 clinics and will self-administer, or if necessary, a study coordinator will administer, a computer-based questionnaire 7-14 days following administration of mifepristone.
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feminist Women's Health Center | Atlanta | Georgia | 30329 | United States | ||
| Family Planning Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25444253 | Derived | Frye LJ, Chong E, Winikoff B; NCT01799252 Trial Investigators. What happens when we routinely give doxycycline to medical abortion patients? Contraception. 2015 Jan;91(1):19-24. doi: 10.1016/j.contraception.2014.09.001. Epub 2014 Sep 15. |
| Label | URL |
|---|---|
| Sponsor website | View source |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Compare the rates of other (non-nausea) side effects between women who are prescribed a seven-day regimen of doxycycline to women who are not prescribed antibiotics following medical abortion
| 7-14 days following medical abortion |
| Additional medications | Compare the use of additional medication to treat side effects between women who take antibiotics and women who do not take antibiotics following medical abortion | 7-14 days following medical abortion |
| Cost | Document the cost to women of antibiotics regimens following medical abortion | at time of filling prescription |
| Chicago |
| Illinois |
| 60630 |
| United States |
| Planned Parenthood Mid and South Michigan | Ann Arbor | Michigan | 48104 | United States |
| Planned Parenthood MN, ND, SD | Saint Paul | Minnesota | 55114 | United States |
| Family Practice and Sidney Hillman Family Practice at the Institute for Family Health | New York | New York | 10003 | United States |
| NYU/Bellevue Hospital Center, Women's Health Center | New York | New York | 10016 | United States |
| Cedar River Clinic | Renton | Washington | 98057 | United States |