Abortion Clinical Trial
Official title:
Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion
Verified date | January 2014 |
Source | Gynuity Health Projects |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 582 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Planned Parenthood Mid and South Michigan | Ann Arbor | Michigan |
United States | Feminist Women's Health Center | Atlanta | Georgia |
United States | Family Planning Associates | Chicago | Illinois |
United States | Family Practice and Sidney Hillman Family Practice at the Institute for Family Health | New York | New York |
United States | NYU/Bellevue Hospital Center, Women's Health Center | New York | New York |
United States | Cedar River Clinic | Renton | Washington |
United States | Planned Parenthood MN, ND, SD | St. Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Gynuity Health Projects |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | adherence | Document the self-reported adherence to antibiotic regimens following medical abortion | 7-14 days following medical abortion | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | Cost | Document the cost to women of antibiotics regimens following medical abortion | at time of filling prescription | No |
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