Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion

Conditions
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Abortion

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who are having MA at the study clinic and are willing to complete a self-administered, computer-based questionnaire 7-14 days after taking mifepristone Women who can read English or Spanish In the doxycycline arm: Women who have been prescribed doxycycline Exclusion Criteria: Women who were treated with antibiotics for a medical condition unrelated to their medical abortion between the initial visit and follow-up appointment Women who have previously enrolled in this study
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Doxy<br>Women who are prescribed a seven-day regimen of doxycycline following medical abortion | |
| No Doxy<br>Women who are not prescribed antibiotics following medical abortion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical abortion, doxycycline, antibiotics, adherence, nausea