Research Project
7391830
DESCRIPTION (provided by applicant): The proposed project is a Phase 3 trial of the drug misoprostol for the treatment of fetal death at 14 to 28 weeks of pregnancy, inclusive. In cases of fetal death this late in pregnancy, it is necessary to clear the uterus of products of conception to avoid serious complications such as generalized coagulopathies. Usually, however, uterine evacuation does not occur spontaneously. Treatments that have been used for this condition previously include dilatation and evacuation surgery, administration of intravenous oxytocin, and administration of prostaglandin E2 suppositories. In recent years, however, most physicians appear to have adopted the practice of administering misoprostol, a prostaglandin E1 analogue, to induce uterine contractions in those patients who do not wish to have a surgical evacuation, or whose pregnancies are so far advanced that surgical evacuation is not possible. Misoprostol has become popular because it is easier to store, is much less expensive, is more effective, and produces fewer side effects than other available treatments. Although misoprostol is, in most places, the treatment of choice for this indication, no large, rigorous study has ever been conducted to determine the most effective dosing regimen for misoprostol in the treatment of fetal death. This study is a randomized, blinded trial of two different doses of misoprostol (100 micrograms versus 200 micrograms administered every 12 hours) administered via the buccal route. The buccal route of administration has been determined to have the best combination of effectiveness, low side effects, patient acceptability, and conformity with misoprostol's current FDA registration. The proposed research will supply data towards establishing a safe minimum effective dose of drug for this indication, with the ultimate goal of formal FDA approval of the treatment. The anticipated public health benefit of this study is that it will help systematize what is currently a chaotic, random use of misoprostol for the treatment of mid-term fetal death. This study will provide, among other things, a lowest effective dose of the drug. Women with this condition need treatment. Misoprostol appears to be a superior treatment to current available treatment regimens. What is lacking is data on how best to use misoprostol for this indication. This study is intended to provide the best treatment regimen for the use of misoprostol for this indication.
