Abstract
Background
Nonsurgical abortion methods have the potential to improve access to high-quality
abortion care. Until recently, availability and utilization of mifepristone medical
abortion in low-resource countries were restricted due to the limited availability
and perceived high cost of mifepristone, leading some providers and policymakers to
support use of misoprostol-only regimens. Yet, this may not be desirable if misoprostol-only
regimens are considerably less effective and ultimately more costly for health care
systems. This study sought to document the differences in efficacy between two nonsurgical
abortion regimens.
Study Design
This double-blind randomized placebo-controlled trial enrolled women with gestational
ages up to 63 days seeking early medical abortion from August 2007 to March 2008 at
a large tertiary hospital in Ho Chi Minh City, Vietnam. Eligible consenting women
received either (1) two doses of 800 mcg buccal misoprostol 24 h apart or (2) 200
mg mifepristone and 800 mcg buccal misoprostol 24 h later. Participants self-administered
all study drugs and returned to the hospital for follow-up 1 week later. The trial
is registered at ClinicalTrials.gov as NCT00680394.
Results
Four hundred women were randomized to either misoprostol-only (198) or mifepristone+misoprostol
(202). Complete abortion occurred for 76.2% (n=147) of women allocated to misoprostol-only vs. 96.5% (n=194) of those given mifepristone+misoprostol (RR 0.79, 95% CI 0.73���0.86). Ongoing
pregnancy was documented for 16.6% (32) of misoprostol-only users and 1.5% (3) of
mifepristone+misoprostol users (1.62, 0.68���3.90). Side effects were generally similar
for both groups, although significantly more women allocated to misoprostol-only reported
diarrhea.
Conclusions
Mifepristone+misoprostol is significantly more effective than use of misoprostol-alone
for early medical abortion. The number of ongoing pregnancies documented with misoprostol-only
warranted an early end of the trial after unblinding of the study at interim analysis.
Policymakers should advocate for greater access to mifepristone. Future research should
prioritize misoprostol-only regimens with shorter dosing intervals.
Keywords
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Article info
Publication history
Published online: October 21, 2010
Accepted:
September 4,
2010
Received in revised form:
September 2,
2010
Received:
June 2,
2010
Footnotes
���This study was funded by an anonymous donor.
Identification
Copyright
© 2011 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
