IVIG FOR RECURRENT MISCARRIAGE: RCT

IVIG 治疗复发性流产：RCT

• 批准号: 7604768
• 负责人: MARY D STEPHENSON
• 金额: $ 1.1万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604768
• 关键词: Autoimmune Process; Birth Rate; Clinical; Computer Retrieval of Information on Scientific Projects Database; Contraceptive methods; Couples; Cytogenetic Analysis; Dose; Drug Kinetics; Endocrine; Enrollment; Funding; Genetic; Grant; Habitual Abortion; Health Care Costs; Immune response; Institution; Intravenous Immunoglobulins; Live Birth; Outcome; Pharmacodynamics; Population; Pregnancy; Pregnancy Trimesters; Procedures; Rate; Recording of previous events; Reporting; Research; Research Personnel; Resources; Source; Specimen; Spontaneous abortion; Treatment Protocols; United States National Institutes of Health; Week; dosage; improved; inclusion criteria; indexing

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 目的： 本临床研究的目的有两个： 1. 评价IVIG在改善不明原因继发性复发性流产夫妇继续妊娠（≥ 20周妊娠）率方面的疗效。 2. 描述和比较IVIG在概念前以及妊娠第1和第2个三个月的药代动力学和药效学参数，以便确定改进的IVIG给药策略。 基本原理： 对于不明原因的继发性复发性流产的夫妇，没有有效的常规治疗或程序。 如果发现IVIG有效，这些夫妇的活产率可能会提高。 从医疗保健成本的角度来看，如果发现IVIG无效，则应放弃进一步用于该适应症。 最后，随着该项目的完成，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中的最佳剂量的信息缺乏。 目前，临床医生根据经验剂量方案，即每周一次至每月一次，开具和施用IVIG。 研究人群： 入选标准： 1)夫妇有不明原因的继发性复发性流产史。 2)最近一次怀孕发生在停止避孕的一年内。 在这项试验中，继发性复发性流产被定义为一个成功的怀孕史（>20周的妊娠），随后至少有三次流产，都是与她现在的伴侣一起怀孕的。 术语？无法解释的？意味着遗传、内分泌、解剖和自身免疫因素已被排除。 成果计量： 成功的首次妊娠定义为妊娠至少20周的持续妊娠。 不成功妊娠定义为细胞遗传学分析为整倍体（正常）的自然流产，或未采集用于细胞遗传学分析或标本未能生长。 主要分析将包括所有初次妊娠的受试者。 还将报告指数妊娠的活产率。 次要分析将是“意向治疗”分析，包括入组试验的所有受试者，无论是否发生妊娠。