IVIG FOR RECURRENT MISCARRIAGE: RCT

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 目标： 这项临床研究的目的有两个： 1.评价静脉注射免疫球蛋白(IVIG)在提高原因不明复发性流产夫妇持续妊娠率中的作用。 2.比较IVIG孕前、孕期和孕中期的药代动力学和药效学参数，以确定改进的IVIG给药方案。 基本原理： 对于原因不明的继发性反复流产的夫妇，目前还没有被证明有效的传统治疗方法或程序。 如果IVIG被发现是有效的，这类夫妇的活产率可能会提高。从医疗成本的角度来看，如果静脉注射免疫球蛋白被发现无效，那么应该放弃对这一适应症的进一步使用。最后，随着这个项目的完成，将更好地了解孕妇对怀孕的免疫反应。 关于IVIG的药代动力学及其在妊娠期的最佳剂量的信息缺乏。目前，临床医生根据经验性剂量方案开出和使用IVIG，即每周一次至每月一次。 研究人群： 纳入标准： 1)夫妻有原因不明的继发性反复流产病史。 2)最近一次怀孕发生在停止避孕一年内。 在这项试验中，继发性复发性流产被定义为成功怀孕(妊娠20周)后至少三次流产，均与她现在的伴侣受孕。“不明原因”一词意味着遗传、内分泌、解剖和自身免疫因素已被排除。 结果衡量标准： 成功的指征妊娠被定义为怀孕至少20周的持续妊娠。不成功妊娠被定义为自然流产，通过细胞遗传学分析是整倍体(正常)的，或者没有采集进行细胞遗传学分析，或者标本不能生长。 初步分析将包括所有有过指征怀孕的受试者。该指数还将报告怀孕的活产率。二次分析将是一项“意向治疗”分析，包括所有参加试验的受试者，无论是否怀孕。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVES: The objectives of this clinical are twofold: 1. To evaluate the efficacy of IVIG in improving the ongoing pregnancy (=20 weeks of gestation) rate in couples with unexplained secondary recurrent miscarriage. 2. To characterize and compare pharmacokinetic and pharmacodynamic parameters for IVIG pre-conceptually and in the 1st and 2nd trimesters of pregnancy, so that an improved IVIG dosing strategy can be determined. RATIONALE: There are no proven effective conventional treatments or procedures available for couples with unexplained secondary recurrent miscarriage. If IVIG is found to be effective the live birth rate for such couples may improve. From a health care cost perspective, if the IVIG is found to be ineffective, then further use for this indication should be abandoned. Finally, with completion of this project, a greater understanding of the maternal immune response to pregnancy will be achieved. Information on the pharmacokinetics of IVIG and its optimal dosing in pregnancy is lacking. Presently, clinicians prescribe and administer IVIG according to empiric dosage regimens, i.e. once weekly to once monthly. STUDY POPULATION: Inclusion Criteria: 1) Couple has a history of unexplained secondary recurrent miscarriage. 2) Most recent pregnancy occurred within one year of discontinuing contraception. In this trial, secondary recurrent miscarriage is defined as a history of a successful pregnancy (>20 weeks of gestation) followed by at least three miscarriages, all conceived with her present partner. The term ¿??unexplained¿?¿ means that genetic, endocrine, anatomical and autoimmune factors have been ruled out. OUTCOME MEASURES: A successful index pregnancy is defined as an ongoing pregnancy of at least 20 weeks of gestation. An unsuccessful pregnancy is defined as a spontaneous abortion which is euploid (normal) by cytogenetic analysis, or which was not collected for cytogenetic analysis or the specimen failed to grow. The primary analysis will include all subjects who had an index pregnancy. Live birth rates will also be reported for the index pregnancies. The secondary analysis will be an "intent to treat" analysis, including all subjects enrolled in the trial, irrespective of whether or not pregnancy occurred.