INDOMETHACIN FOR ADJUVANT TOCOLYSIS

吲哚美辛辅助安胎

• 批准号: 6881651
• 负责人: GEORGE A MACONES
• 金额: $ 5.42万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-05-04 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6881651
• 关键词: clinical trials; gestational age; human pregnant subject; human therapy evaluation; indomethacin; infant mortality; magnesium; outcomes research; patient oriented research; pregnancy disorder chemotherapy; premature infant human; premature labor; sulfates; tocolytic agents; women' s health

DESCRIPTION (Adapted from applicant's description): Applicant: George A. Macones, M.D., M.S.C.E. is the Principal Investigator and Candidate for this award. Dr. Macones is an established clinical researcher, who has been successful in obtaining federal grants for clinical research. He has a track record of mentoring young investigators, including Master's trainees in Clinical Epidemiology, Maternal-Fetal Medicine Fellows, OB/GYN residents, and medical students. Dr. Macones' goals are to make important contributions to the clinical care of pregnant women, as well as to be an integral part of the training of the next generation of patient oriented researchers in obstetrics and gynecology. Research Plan: To use a randomized clinical trial to test the hypothesis that indomethacin, when used for adjuvant tocolysis in preterm labor (i.e., in those who are failing to respond to conventional first-line therapy), can decrease the rate of major neonatal complications and death. The proposed research project will use a double-blind, parallel, randomized controlled clinical trial design to compare the efficacy of indomethacin to placebo for adjuvant tocolysis in pregnancies less than 30 weeks gestation. Patient will be recruited for this study from the Labor and Delivery wards of the Hospital of the University of Pennsylvania, the Pennsylvania Hospital, the Thomas Jefferson University Hospital, and Christiana Care Health Services. Patients who "fail" first-line therapy with magnesium sulfate will be evaluated for possible enrollment into this randomized clinical trial. Those who give informed consent will be enrolled into the study. This study calls for the enrollment of 205 patients in both arms. Patients will be randomized to receive either indomethacin rectal suppositories (50mg every 6 hours) or identical appearing placebo suppositories for 48 hours. After completion of treatment with either placebo or indomethacin, patient care will be largely at the discretion of the attending physicians. Many prior studies of tocolysis have used variable periods of delay in delivery as the primary outcome measure. We believe that this is not the appropriate primary endpoint, since the ultimate goal of tocolysis is to improve neonatal outcome. Thus, although delivery delay will be analyzed as a secondary endpoint, our primary outcome (on which our sample size is based) will be based on major neonatal morbidity. Mentoring Plan: Dr. Macones has established himself as a mentor to young investigators interested in clinical research, and has spent a large portion of his time on this activity. He will continue this activity over the course of this proposal, and will focus on students in the Master of Science program in Clinical Epidemiology at the University of Pennsylvania, as well as on fellows who receive support form the NIH sponsored training grant in Reproductive Clinical Epidemiology or in the new track in Patient Oriented Research.

描述(改编自申请人的描述)：申请人：乔治·A。 Macones，M.D.，M.S.C.E.是这项研究的主要调查者和候选人 获奖。Macones博士是一位知名的临床研究人员，他一直 成功地获得了临床研究的联邦拨款。他有一条赛道 指导年轻调查人员的记录，包括#年硕士学员 妇产科临床流行病学、母胎医学研究员 住院医生和医科学生。Macones博士的目标是使重要的 为孕妇的临床护理做出贡献，以及成为一名 培养下一代以病人为中心的人是不可或缺的部分 产科和妇科的研究人员。 研究计划：使用随机临床试验来检验这一假设 吲哚美辛，用于早产的辅助性宫缩(即 那些对传统一线治疗无效的人)，可以 降低新生儿主要并发症和死亡率。建议数 研究项目将采用双盲、平行、随机对照 比较消炎痛与安慰剂疗效的临床试验设计 妊娠小于30周的孕妇辅助性宫缩。病人意志 从医院的产房和产房招募参加这项研究 宾夕法尼亚大学、宾夕法尼亚医院、托马斯医院 杰斐逊大学医院和克里斯蒂娜医疗保健服务。病人 谁的硫酸镁一线治疗“失败”将被评估 有可能加入这项随机临床试验。那些给予的人 知情同意将被纳入这项研究。这项研究呼吁 登记两个手臂的205名患者。患者将被随机分配到 接受消炎痛直肠栓(每6小时50毫克)或 48小时内出现相同的安慰剂栓剂。在完成后 使用安慰剂或吲哚美辛治疗，患者护理将主要集中在 主治医生的判断力。许多先前关于宫缩的研究 使用了不同的交货延迟时间作为主要结果 测量。我们认为这不是合适的主要终点，因为 宫缩的最终目的是改善新生儿的结局。因此，虽然 交付延迟将作为次要终点进行分析，这是我们的主要结果 (我们的样本量所基于的)将基于主要的新生儿发病率。 指导计划：Macones博士已经确立了自己作为年轻人的导师的地位 研究人员对临床研究感兴趣，并花费了很大一部分时间 他在这项活动上的时间。他将在整个课程中继续这项活动 ，并将重点放在理科硕士项目的学生身上 宾夕法尼亚大学的临床流行病学，以及 从国立卫生研究院赞助的培训补助金中获得支持的研究员 生殖临床流行病学或走上以患者为中心的新轨道 研究。