To the Editor:
We were disheartened to read the low success rates reported by Vitner, Machtinger, et al. in “High failure rates of medical termination of pregnancy after introduction to a large teaching hospital” (1). Medical abortion is among the most effective and safe medical interventions available. Reported rates of ongoing pregnancy in the literature vary from 0.2% to 1% (2, 3), and transfusion rates from 0 to 0.2% (4-6). For example, Planned Parenthood Federation of America, the largest provider of mifepristone abortion in the United States, had a complication rate of just 2.2 per 1000 for the 95,163 women its affiliates treated over a 3¼ year period (7). The disparity between the authors’ findings and the literature to date is alarming.
We agree with their conclusions that their low success rates were due to over-diagnosis of “failure” with inappropriate sonographic criteria alongside clinician inexperience. In addition, however, their site used a medical abortion regimen that follows product labeling but not the current evidence-based standard of care. Recent clinical guidelines recommend 200 mg mifepristone (as a WHO study in 1997 and a Cochrane Review in 2004 showed no advantage to 600 mg)(8, 9) and an 800 microgram dose of misoprostol administered either vaginally or buccally. The guidelines of both the WHO and the Royal College of Obstetricians and Gynaecologists recommend using 800 micrograms of misoprostol vaginally after 200 mg mifepristone (9, 10). In the United States, with experience of about 1,000,000 procedures, our major provider networks recommend 200 mg oral mifepristone and a variety of misoprostol regimen (Planned Parenthood, 800 mcg buccal misoprostol to 63 days LMP; National Abortion Federation 800 mcg vaginal or buccal misoprostol to 63 days LMP). These regimens have been shown repeatedly in clinical trials to be more effective than the labeled one.
It seems to us that the conclusion to be drawn from this journal article is not that successful introduction of medical abortion into a large teaching hospital is difficult, but rather how definitively this particular site set itself up for failure.Yael Swica, MD, MPH
Beverly Winikoff, MD, MPH
Gynuity Health Projects
New York, NY
1. Vitner D, Machtinger R, Baum M., Goldenberg M, Schiff E, Seidman D. High failure rates of medical termination of pregnancy after introduction to a large teaching hospital. Fertility and Sterility, 2008.
2. Spitz, I.M. et al. Early pregnancy termination with mifepristone and misoprostol in the United States. New England Journal of Medicine, 1998. 338(18): p. 1241-7.
3. Schaff, E.A., et al., Vaginal misoprostol administered 1, 2, or 3 days after mifepristone for early medical abortion: A randomized trial.(erratum appears in JAMA 2000 Nov 22-29;284(20):2597). JAMA, 2000. 284(15): 1948-53.
4. Schaff, E.A., et al., Low-dose mifepristone followed by vaginal misoprostol at 48 hours for abortion up to 63 days. Contraception, 2000. 61(1):41-6.
5. Creinin, M.D. et al. A randomized comparison of misoprostol 6 to 8 hours versus 24 hours after mifepristone for abortion. Obstetrics & Gynecology, 2004. 103(5 Pt 1): 851-9.
6. Hausknecht R.Mifepristone and misoprostol for early medical abortion: 18 months experience in the United States. Contraception, 2003. 67(6): 463-5.
7. Henderson, J.T., et al., Safety of mifepristone abortions in clinical use. Contraception, 2005. 72(3): 175-178.
8. WHO Scientific Group WHO Technical Report Series, 1997. 871.
9. Kulier R. et al. Medical methods for first trimester abortion.(update of Cochrane Database Syst Rev. 2004;(1):CD002855; PMID: 14973995). Cochrane Database of Systematic Reviews, 2004(2): CD002855.
10. Safe abortion: technical and policy guidance for health systems. 2003, World Health Organization: Geneva.
Published online in Fertility and Sterility DOI: 10.1016/j.fertnstert.2008.12.081
The Authors Reply:
We would like to thank Drs. Swica and Winikoff for their interest in our study (1). Although it may be more inspiring to report high success rates, we thought it would be worthy to honestly evaluate our admittedly disappointing results in the hope of stirring exactly this kind of thoughtful response. We agree with the authors that medical abortion is a highly effective and safe procedure. However, the failure in implementing it in one of Israel’s largest and most experienced academic centers does point out that under some clinical circumstances follow-up procedures may be more complicated to implement than previously considered.
In Israel, as in many other countries, physicians are allowed to follow only the manufacturer’s labeled regimen, and therefore we could not legally adopt other protocols. It should be noted that all four fatal cases of acute shock complicating Clostridium sordellii endometritis so far reported occurred following medical abortion with mifepristone used with vaginal, rather than oral, misoprostol, thereby defying the labeled regimen (2). The pathogenesis of this unexpected complication remains enigmatic, although a recent study has suggested that misoprostol may impair the female reproductive tract’s innate immunity against Clostridium sordellii (3).
Swica and Winikoff do not present any data regarding the ease of introducing medical abortion into large teaching hospitals, and they refer to high success rates reported in studies coming from centers with a specific interest in providing termination of pregnancy. We believe that it is likely that other university centers, with a more limited service providing induced abortion, may at first face difficulties similar to ours. We hope that our reported experience may help them achieve more rapidly the desired high success rates.
Daniel S. Seidman, MD Department of Obstetrics and Gynecology
Chaim Sheba Medical Center
52621 Tel-Hashomer, Israel
1. Vitner D., M.R., Baum M., Goldenberg M., Schiff E., Seidman D., High failure rates of medical termination of pregnancy after introduction to a large teaching hospital. Fertil Steril, 2008.
2. Fischer M, et al. Fatal toxic shock syndrome associated with Clostridium sordellii after medical abortion. N Engl J Med 2005;353:2352-60.