MISOPROSTOL FOR TREATMENT OF FETAL DEATH AT 14-28 WEEKS PHASE III

描述（由申请人提供）： 拟议的项目是一项关于米索前列醇治疗妊娠14至28周（含）胎儿死亡的3期试验。 如果在怀孕后期发生胎儿死亡，有必要清除子宫中的受孕产物，以避免出现严重并发症，例如全身性凝血功能障碍。然而，子宫排空通常不会自发发生。 以前用于这种情况的治疗包括扩张和排空手术，静脉注射催产素和前列腺素E2栓剂。 然而，近年来，大多数医生似乎都采用了给药米索前列醇（一种前列腺素E1类似物）的做法，以诱导那些不希望进行手术排空或妊娠晚期无法进行手术排空的患者的子宫收缩。 米索前列醇已经变得流行，因为它更容易储存，更便宜，更有效，并且比其他可用的治疗方法产生更少的副作用。 虽然米索前列醇在大多数地方是治疗该适应症的首选，但尚未进行大规模、严格的研究来确定米索前列醇治疗胎儿死亡的最有效给药方案。 这项研究是一项随机、设盲试验，通过口腔途径给予两种不同剂量的米索前列醇（每12小时给予100微克和200微克）。 口腔给药途径已被确定为具有有效性、低副作用、患者可接受性和符合米索前列醇当前FDA注册的最佳组合。 拟议的研究将提供数据，以建立该适应症的安全最低有效剂量的药物，最终目标是FDA正式批准该治疗。 这项研究的预期公共卫生效益是，它将有助于系统化目前混乱，随机使用米索前列醇治疗中期胎儿死亡。 除其他外，这项研究将提供药物的最低有效剂量。 患有这种疾病的女性需要治疗。 米索前列醇似乎是一种优于当前可用治疗方案的上级治疗。 目前缺乏的是关于如何最好地使用米索前列醇用于这一适应症的数据。 本研究旨在为米索前列醇用于该适应症提供最佳治疗方案。

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.