NCT01799252

Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 582 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Abortion

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-02-26
• Last updated: 2014-02-03

Locations

7 sites across 1 country: United States