Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 582
- Locations
- 7
- Primary Endpoint
- Incidence rates of nausea
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Incidence rates of nausea
Time Frame: 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
Time Frame: 7-14 days following medical abortion
Document the self-reported adherence to antibiotic regimens following medical abortion
Secondary Outcomes
- 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)