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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01799252
Other study ID # 7000
Secondary ID
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


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
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