Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy

The purpose of the proposed study is to test - in a randomized, blinded trial - two
different doses of the prostaglandin E1 analogue misoprostol administered buccally as a
treatment for fetal death at 14 - 28 weeks, inclusive, of pregnancy. At such an advanced
stage of pregnancy, the nonviable fetus is often not spontaneously evacuated, and yet timely
evacuation is vital in order to avoid the possibility of, among other things, potentially
life-threatening maternal coagulopathies. Current approaches to uterine evacuation in these
cases include dilatation and evacuation (D&E) surgery (in less advanced pregnancies) and
labor induction with a variety of products. Misoprostol has been demonstrated to be as
effective as, or more effective than, either oxytocin or prostaglandin E2 analogues for this
indication in a number of small, non-FDA-approved trials which have been published in the
peer-reviewed literature. In the absence of more formal study of this treatment, however,
dosages are not standardized, pathways of administration vary, and other uncertainties
linger. The purpose of the protocol proposed herein is to formally establish, via a
randomized, double-blinded study, the safety and effectiveness of misoprostol for this
indication, and to compare the value of two distinct doses, so that providers may
henceforward proceed with greater authority and confidence.