Gynuity Health Projects

Programs

Misoprostol for Treatment of Intra-uterine Fetal Death in the Second Trimester

Because of the scarcity of well-trained surgical providers, more and more physicians have begun turning to misoprostol as an alternative approach to surgical evacuation of the uterus after fetal death in the 2nd trimester. Misoprostol has been demonstrated to be as effective as, or more effective than, either oxytocin or other prostaglandins for this indication in a number of small trials published in the peer-reviewed literature. For many obstetricians, misoprostol has become the accepted standard of care for 2nd trimester intrauterine fetal death. In the absence of more formal study of this treatment, however, dosages are not standardized, routes of administration vary, and other issues, such as timing of doses and total dose have not been settled.

In collaboration with US-based researchers, Gynuity is conducting a study testing, in a randomized, blinded trial, two different doses of misoprostol (200mcg vs. 100mcg) administered buccally as a treatment for fetal death at 14 – 28 weeks’ gestation. The purpose is to establish the lowest safe and effective dose of misoprostol for this indication so that providers may proceed with greater authority and confidence. The data from the study should enable a pharmaceutical entity to register misoprostol for the treatment of IUFD in the second trimester. Gynuity has been awarded orphan drug status for misoprostol for this indication and is able to undertake this research because of our receipt of a competitive award from the US Food and Drug Administration.