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

描述(由申请人提供)： 拟议的项目是米索前列醇治疗怀孕14至28周(包括14至28周)胎儿死亡的第三阶段试验。在妊娠晚期胎儿死亡的情况下，有必要清除子宫中的受孕产物，以避免严重的并发症，如全身凝血疾病。然而，通常情况下，子宫排空不会自发发生。以前用于这种情况的治疗方法包括扩张和排空手术，静脉注射催产素，以及前列腺素E2栓剂。然而，近年来，大多数医生似乎都采用了使用米索前列醇(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卵的患者的子宫收缩，或者这些患者的怀孕已经很晚，无法进行手术排卵。米索前列醇变得流行起来，因为它比其他可用的治疗方法更容易储存，更便宜，更有效，产生的副作用更少。 尽管在大多数地方，米索前列醇是这一适应症的首选治疗方法，但还没有进行过大规模、严格的研究，以确定米索前列醇在治疗胎儿死亡方面最有效的剂量方案。这项研究是一项随机、盲法试验，两种不同剂量的米索前列醇(每12小时给药100微克和200微克)经口腔给药。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目前FDA注册的最佳组合。这项拟议的研究将为建立该适应症的安全最小有效药物剂量提供数据，最终目标是FDA正式批准该治疗。 这项研究预期的公共健康益处是，它将有助于将目前混乱、随机使用米索前列醇治疗中期胎儿死亡的做法系统化。这项研究将提供该药物的最低有效剂量等。患有这种疾病的女性需要治疗。米索前列醇似乎是比目前可用的治疗方案更好的治疗方案。缺乏关于如何最好地使用米索前列醇来治疗这一适应症的数据。这项研究旨在为米索前列醇用于这一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.