Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 582
- 试验地点
- 7
- 主要终点
- Incidence rates of nausea
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence rates of nausea
时间窗: 7-14 days following medical abortion
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
adherence
时间窗: 7-14 days following medical abortion
Document the self-reported adherence to antibiotic regimens following medical abortion
次要结局
- Nausea rates(7-14 days following medical abortion)
- Non-nausea side effects(7-14 days following medical abortion)
- Additional medications(7-14 days following medical abortion)
- Cost(at time of filling prescription)