2 October 2009
Clinical Update: Reducing serious infection following early medical abortion
By Professor James Trussell, Director of the Office of Population Research, Princeton University.
This Q&A is based on the paper ‘Rates of serious infection after changes in regimens for medical abortion’, by Fjerstad M, Trussell J, Sivin I, Lichtenberg ES, Cullins V. New England Journal of Medicine 2009 Jul 9;361(2):145-51.
- Q) What was the rate of serious infection following early medical abortion in Planned Parenthood (PP) health centres between 2001 and 2006?
From 2001 through March 2006, PP health centres provided 219,724 medical abortions to 63 days’ gestation by a regimen of 200 mg oral mifepristone followed 24-48 hours later by 800 μg of vaginal misoprostol, self-administered at home. During the period 2001-Q1 2004, the rate of infection requiring inpatient or outpatient treatment was 23/100,000 medical abortions. Concerns about incomplete reporting of medical abortion led to two changes: 1) PPFA (Planned Parenthood Federation of America) Medical Standard and Guidelines were changed in 2004 to require that all serious adverse events be reported centrally to one person; 2) Planned Parenthood health centres are audited on-site for internal accreditation by PPFA. Since 2005, the accreditation process has included auditing to verify that mifepristone adverse events are submitted as required.
The rate of serious infection at PP health centres during the period 2005-Q1 2006 was 89/100,000, nearly four times that expected from earlier experience at PP. And by late 2005, four women in the US and one in Canada had died from a rare bacterial infection with Clostridium sordellii following medical abortion.
- Q) What is a ‘serious’ infection?
We defined serious infections as cases where the patient has fever accompanied by pelvic pain and is treated with IV antibiotics either in an emergency department or in-patient unit, or cases where sepsis or death caused by infection is documented.
- Q) What measures were put in place to try to reduce the serious infection rate?
Two changes, neither evidence-based, were made. First, the route of administration of misoprostol was changed from vaginal to buccal (200 mg mifepristone followed 24-48 hours later by 800 μg of buccal misoprostol, 400 μg in each cheek for 20 min). Second, routine antiseptics were replaced by one of two new infection control measures:
- EITHER universal testing for Chlamydia (and gonorrhoea where appropriate (treatment consisting of doxycycline orally 100 mg BID x 7 days for Chlamydia, and for gonorrhoea, ceftriaxone 125 mg IM in a single dose);
- OR routine antibiotic coverage (doxycycline orally 100mg BID for 7 days, starting the same day as mifepristone administration).
- Q) What was the outcome of these changes?
The rates of serious infection significantly declined in both groups, by 61% in the screen-and-treat group and 93% in the routine antibiotic group. Because the decline in the routine antibiotic group was significantly greater than the decline in the screen-and-treat group, in July 2007, PPFA required all health centres to provide antibiotics to all women having medical abortions.
- Q) What can researchers and practitioners conclude from this?
The joint change from:
- Vaginal to buccal administration of misoprostol and
- Standard antiseptic measures to routine antibiotic coverage
reduced the rate of serious infection by 93%, from 92.8 to 6.9 per 100,000. Unfortunately, it is not possible to know what share of the overall decline was associated with each change individually since both were made at the same time. However, because there was a further significant decline in the serious infection rate when the screen-and-treat group subsequently changed to routine antibiotic coverage, we know that the change to routine antibiotic coverage alone must account for some of the decline.
- Q) How does the situation in the USA differ from that in the UK - both in terms of infection rates and clinical practice?
The rate of serious infection following medical abortion in the UK is not known. Buccal administration of misoprostol is rare. However, many, if not most, but certainly not all providers of medical abortion in the UK follow the 2004 RCOG guidelines that mandate routine antibiotic coverage (though not with doxycycline).
- Q) Are there any lessons to be learned in the UK from the US experience?
All we can report is what happened when we made changes. Questions remain about whether routine antibiotic coverage is cost effective in either the US or the UK.
EARLY MEDICAL ABORTION AT BPAS
By Patricia Lohr, Medical Director, BPAS
At BPAS, EMA is undertaken by administration of 200 mg oral mifepristone followed 6-72 hours later by 800 mcg misoprostol inserted vaginally in the clinic, either by the client or a nurse depending on the woman’s preference. We use vaginal misoprostol because it offers the greatest flexibility in the interval between medications, lowest rate of side effects, and high effectiveness. We do have the option of using regimens with oral or buccal misoprostol for women who cannot tolerate vaginal administration, but they are uncommonly used.
All women undergoing EMA at BPAS receive prophylactic treatment for Chlamydia. Our standard regimen is doxcycline 100 mg orally twice a day for 7 days (the same regimen used in the New England Journal of Medicine paper, reported on above) although we have some contracts that specify use of a single oral dose of azithromycin 1g.
For more information about the provision of EMA at BPAS, see the publication Early Medical Abortion: A Guide for Practitioners, available to download for free here.
This article appears in the Autumn 2009 print edition of Abortion Review.
Abortion Review topic archive: Clinical Update Q&A