Sublingual Versus Vaginal Misoprostol for Labor Induction at Term
Status:
Completed
Trial end date:
2006-09-01
Target enrollment:
Participant gender:
Summary
Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the
United States since 1988 as a gastric cytoprotective agent. In contradistinction to
prostaglandin E2 preparations (dinoprostone, Prepidil, Cervidil), misoprostol is inexpensive
and available in scored tablets that can be broken and inserted vaginally. Despite a focused
campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over
the past several years, gained widespread acceptance as both a labor induction and a cervical
ripening agent. Such off-label indication has been endorsed by the American College of
Obstetricians and Gynecologists and other medical bodies. Recently, FDA approved a new label
for the use of cytotec during pregnancy which removed pregnancy as a contraindication for its
use. Vaginal administration seems to be more efficacious than when given orally, although
there is the worry of uterine tachysystole and hyperstimulation with vaginal doses > 50-µg.
The use of sublingual misoprostol for cervical ripening at term was recently investigated in
two studies that compared it to the oral route, on the assumption that the sublingual route
would have the higher efficacy of the vaginal route by avoiding the first pass effects of the
gastrointestinal and hepatic systems, while having lower hyperstimulation rates by avoiding
the direct effects on the cervix. 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 induction of labor at term. Our aim is to
compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the
current standard) to that given sublingually.