Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion

Gynuity Health Projects

Status: Completed

Conditions: Abortion

Study type: Observational

Funder types: Other

Identifiers

NCT01799252

7000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 582 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

582 participants in 2 patient groups

Doxy

Description:

Women who are prescribed a seven-day regimen of doxycycline following medical abortion

No Doxy

Description:

Women who are not prescribed antibiotics following medical abortion