Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion

Completed

• Conditions: Abortion

• Registration Number: NCT01799252
• Lead Sponsor: Gynuity Health Projects

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 Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2013-02-23
• Study First Posted: 2013-02-26
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-30
• Last Update Posted: 2014-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 582

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rates of nausea	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	7-14 days following medical abortion	Document the self-reported adherence to antibiotic regimens following medical abortion

Secondary Outcome Measures

Name	Time	Method
Nausea rates	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
Non-nausea side effects	7-14 days following medical abortion	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
Additional medications	7-14 days following medical abortion	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
Cost	at time of filling prescription	Document the cost to women of antibiotics regimens following medical abortion

Trial Locations

Locations (7)

NYU/Bellevue Hospital Center, Women's Health Center; 🇺🇸 New York, New York, 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

Planned Parenthood Mid and South Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Planned Parenthood MN, ND, SD; 🇺🇸 St. Paul, Minnesota, United States

Cedar River Clinic; 🇺🇸 Renton, Washington, United States