Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion

Abortion Clinical Trial

Official title:

Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799252
• Other study ID #: 7000
• Status: Completed
• Phase: N/A
• First received: December 7, 2012
• Last updated: January 30, 2014
• Start date: November 2012
• Est. completion date: December 2013

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abortion

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Sponsor website