- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01799252
Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30329
- Feminist Women's Health Center
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Illinois
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Chicago, Illinois, United States, 60630
- Family Planning Associates
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Michigan
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Ann Arbor, Michigan, United States, 48104
- Planned Parenthood Mid and South Michigan
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Minnesota
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St. Paul, Minnesota, United States, 55114
- Planned Parenthood MN, ND, SD
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New York
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New York, New York, United States, 10003
- Family Practice and Sidney Hillman Family Practice at the Institute for Family Health
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New York, New York, United States, 10016
- NYU/Bellevue Hospital Center, Women's Health Center
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Washington
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Renton, Washington, United States, 98057
- Cedar River Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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7-14 days following medical abortion
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adherence
Time Frame: 7-14 days following medical abortion
|
Document the self-reported adherence to antibiotic regimens following medical abortion
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7-14 days following medical abortion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nausea rates
Time Frame: 7-14 days following medical abortion
|
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
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7-14 days following medical abortion
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Non-nausea side effects
Time Frame: 7-14 days following medical abortion
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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
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7-14 days following medical abortion
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Additional medications
Time Frame: 7-14 days following medical abortion
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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
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7-14 days following medical abortion
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Cost
Time Frame: at time of filling prescription
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Document the cost to women of antibiotics regimens following medical abortion
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at time of filling prescription
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 7000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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