A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Termination for Intrauterine Fetal Death
Terminated
American University of Beirut Medical Center
Phase 3
2004-09-01
Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the
United States since 1988 as a gastric cytoprotective agent. Despite a focused campaign by the
manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several
years, gained widespread acceptance to effect the medical termination of pregnancy in the
second trimester, either alone or after pretreatment with mifepristone. The primary reasons
for this prompt incorporation into standard practice include its low cost and the lack of
stringent storage requirements.
Vaginal administration seems to be more efficacious than when given orally. The use of
sublingual misoprostol for first trimester abortions has been extensively investigated as
evidenced by the large number of publications comparing sublingual to other routes of
misoprostol for first trimester pregnancy termination, on the assumption that the sublingual
route would have a similar efficacy of the vaginal route. In addition, the sublingual route
would combine an easier administration with the added advantage of no restriction of mobility
after administration. There has been no previous report in the literature comparing the use
of misoprostol given sublingually to that given vaginally for the second trimester
termination following intrauterine fetal death. Our aim is to compare efficacy, safety and
patient satisfaction with misoprostol given vaginally (the current standard) to that given
sublingually.
The purpose of the study was to compare the safety and efficacy of two agents used in
induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2
(Dinoprostone vaginal Tablet).
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