Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion

January 30, 2014 updated by: Gynuity Health Projects
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 Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

582

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Feminist Women's Health Center
    • Illinois
      • Chicago, Illinois, United States, 60630
        • Family Planning Associates
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Planned Parenthood Mid and South Michigan
    • Minnesota
      • St. Paul, Minnesota, United States, 55114
        • Planned Parenthood MN, ND, SD
    • New York
      • New York, New York, United States, 10003
        • Family Practice and Sidney Hillman Family Practice at the Institute for Family Health
      • New York, New York, United States, 10016
        • NYU/Bellevue Hospital Center, Women's Health Center
    • Washington
      • Renton, Washington, United States, 98057
        • Cedar River Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

This study will enroll 610 women. Women will be recruited from 5 clinics and will self-administer, or if necessary, a study coordinator will administer, a computer-based questionnaire 7-14 days following administration of mifepristone.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Doxy
Women who are prescribed a seven-day regimen of doxycycline following medical abortion
No Doxy
Women who are not prescribed antibiotics following medical abortion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rates of nausea
Time Frame: 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
7-14 days following medical abortion
adherence
Time Frame: 7-14 days following medical abortion
Document the self-reported adherence to antibiotic regimens following medical abortion
7-14 days following medical abortion

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 7, 2012

First Submitted That Met QC Criteria

February 23, 2013

First Posted (Estimate)

February 26, 2013

Study Record Updates

Last Update Posted (Estimate)

February 3, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 7000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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