Mary Fjerstadt


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    Decline in rates of serious infection following medical abortion regimen changes

    American practice and overwiew of the Clostridium infections

    Mary Fjerstad, N.P., M.H.S., Senior Clinical Advisor, Medical Abortion Ipas, USA

    Co-authors: James Trussell, Ph.D, Iriving Sivin, M.A., E. Steve Lichtenberg, M.D., M.P.H. and Vanessa

    Cullins, M.D., M.P.H, M.B.A.

    Background: From January 1, 2005 through June 30, 2008, we tracked 227,823 women having medical abortion at Planned Parenthood clinics in the U.S.  In the first time period, January 1, 2005 through March 31, 2006, the medical abortion regimen used was mifepristone 200 mg followed 24-48 hours later by misoprostol 800 mcg vaginally. There was not a standardized practice for testing or treatment of infection. During this period, among the Planned Parenthood data, the rate of serious infection was 0.93 per thousand medical abortions. Serious infection was defined as those requiring IV antibiotics in the emergency department, hospitalization, surgery necessary to remove an infected organ, or death. In early 2006, Planned Parenthood changed the route of misoprostol administration from vaginal to buccal and required either routine provision of antibiotics or universal screening for chlamydia and treatment of positive cases. In July 2007, Planned Parenthood required routine antibiotics as part of the medical abortion regimen.

    Methods: This was a retrospective analysis based on mandatory reports of number of medical abortions provided each quarter and reports of adverse events mandated by the Food and Drug Administration under Subpart H approval of mifepristone.

    Results: Rates of serious infection dropped significantly after the joint change to buccal administration of misoprostol and to either: 1) testing for sexually transmitted infection or 2) routine antibiotics. There was a 73% decline seen by instituting these changes to a rate of serious infection from 0.93 per 1000 abortions to 0.25 per thousand.  The subsequent change to routine provision of antibiotics led to a further significant reduction in the rate of serious infection- a 76% decline, from 0.25 per 1000 abortions to 0.06 per thousand.

    Conclusions: The maximum contribution of the change to the buccal route of misoprostol could be as high as 67% (if screen-and-treat were completely ineffective), and as low as 0%. It seems unlikely that screen-and-treat was completely ineffective, because at least some who test positive would have been treated in time to prevent serious infection. The maximum contribution of routine use of antibiotics could be as high as 100% (if the switch to buccal administration of misoprostol were completely ineffective) and no lower than 33%.

    The rate of serious infection after medical abortion declined by 93% after a change from vaginal to buccal administration of misoprostol combined with routine administration of antibiotics.

    Although there have been 9 deaths in North America; 8 caused by Clostridium sordellii and one caused by Clostridium perfringens, there have not been reports elsewhere in the world of infection-related mortality following medical abortion. 

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    Infection related mortality following medical abortion in North America
    Mary Fjerstadt, Clinical Training Director, Planned Parenthood
    Consortium of Abortion Providers, El Cajon, USA
    Among an estimated 560,000 women who have had medical abortion with mifepristone
    and misoprostol in North America, there have been 6 deaths related to infection:
    One death in Canada during clinical trials: C. sordellii
    Four deaths in California: C. sordellii
    One death in western U.S.- C. perfringens
    FDA and CDC held a meeting in May 2006 to discuss what is known and unknown about
    C. sordelii. Since the FDA/CDC meeting and the publication of the article in the New
    England Journal of Medicine about the C. sordellii deaths and mifepristone abortion,
    reports of C. sordellii following spontaneous abortion and childbirth have emerged.
    This presentation will discuss the conclusions of the FDA/CDC meeting, the clinical
    presentation of the cases, the hypotheses that have been put forward to explain why these
    infectious deaths have occurred, and the system of adverse event reporting in the U.S.
    and Planned Parenthood.

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    Outcomes of various medical abortion research have been difficult to compare.  Outcomes such as “effective”, “successful”, “complete” are defined differently in various studies or sometimes not defined. “Adverse events” similarly may not be reported or reported without clear definition.

    The goal of Medical Abortion Reporting of Efficacy (MARE) guidelines is to standardize early medical abortion efficacy reporting to facilitate comparison of outcomes between studies and to enhance data synthesis from different studies. This brief presentation will discuss the MARE guidelines for research methods. 
    Eligibility: the eligibility criteria for participants should be clearly stated, including the range of gestational age, the methods used to determine gestational age, and the conditions for ineligibility.
    Interventions: the study should state the medications used, including dose(s) and route(s) of administration.  The planned time interval (in hours) between medications should be stated.
    Outcomes: researchers should define primary and secondary outcome measures, including how and when they were assessed. 

    • Define successful medical abortion:  MARE guidelines propose that “successful” medical abortion should be defined as successful expulsion of the intrauterine pregnancy without need for surgical intervention. 
    • There are several categories of medical abortion failure:
      • Ongoing pregnancy. Continuing pregnancy should be defined as a viable pregnancy following treatment (differentiated from a retained gestational sac)
      • Incomplete abortion

    Heavy or problematic bleeding
    Assessment: Describe follow-up assessment used to determine outcome, for example, combination of ultrasound and physical exam, any pregnancy tests, symptoms checklist, etc. State the length of time planned to follow participants to determine outcomes. Reporting outcomes in a standardized manner will enhance data synthesis to produce evidence-based guidelines. 

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    Medical abortion with home administration of misoprostol
    Mary Fjerstadt, Clinical Training Director, Planned Parenthood
    Consortium of Abortion Providers, El Cajon, USA
    There are now over 250 Planned Parenthood clinics in the U.S. providing mifepristone
    medical abortion. Since initiation of medical abortion in 2000, women have received
    mifepristone in the clinic on Day One, and also receive misoprostol to self-administer at
    home. 230,000 women have received medical abortion with home administration of
    misoprostol. Women are given information about how to administer the medication, what
    to expect, and when they should call the medical provider.
    The presentation will discuss the efficacy of regimens used in the U.S., the rate of surgical
    intervention and the rate of emergency department visits. Most bleeding events requiring
    emergency treatment occur later in the process and would not have been prevented by
    using misoprostol in the clinic setting.