INDOMETHACIN FOR ADJUVANT TOCOLYSIS

吲哚美辛辅助安胎

• 批准号: 6286781
• 负责人: GEORGE A MACONES
• 金额: $ 13.9万
• 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 2006-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6286781
• 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：George A. 马康内斯，医学博士，理学硕士是该项目的首席研究员和候选人 奖。 Macones 博士是一位资深的临床研究员， 成功获得联邦临床研究资助。 他有一个轨道 指导年轻研究人员的记录，包括硕士研究生 临床流行病学、母胎医学研究员、妇产科 居民和医学生。 Macones 博士的目标是让重要的 为孕妇的临床护理做出贡献，并成为一名 下一代以患者为导向的培训的组成部分 妇产科研究人员。 研究计划：使用随机临床试验来检验以下假设： 吲哚美辛，当用于早产（即早产）的辅助安胎时 那些对传统一线治疗没有反应的人），可以 降低主要新生儿并发症和死亡率。 拟议的 研究项目将采用双盲、平行、随机对照 比较吲哚美辛与安慰剂疗效的临床试验设计 妊娠小于 30 周的妊娠辅助安胎。 病人会 从医院的产房和分娩病房招募参加本研究 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护理健康服务中心。 患者 硫酸镁一线治疗“失败”的人将接受评估 可能参加这项随机临床试验。那些给予的人 知情同意将被纳入该研究。 这项研究呼吁 双臂共入组 205 名患者。患者将被随机分配至 接受吲哚美辛直肠栓剂（每 6 小时 50 毫克）或 48 小时内外观相同的安慰剂栓剂。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 主治医生的酌情权。许多先前的安胎研究 使用不同时期的分娩延迟作为主要结果 措施。 我们认为这不是合适的主要终点，因为 安胎的最终目标是改善新生儿结局。因此，虽然 交货延迟将作为次要终点进行分析，这是我们的主要结果 （我们的样本量以此为基础）将基于主要的新生儿发病率。 指导计划：Macones 博士已成为年轻人的导师 研究人员对临床研究感兴趣，并且花费了很大一部分 他参与这项活动的时间。 他将在整个课程中继续这项活动 该提案的重点是理学硕士课程的学生 宾夕法尼亚大学临床流行病学博士以及 获得 NIH 资助的培训补助金支持的研究员 生殖临床流行病学或处于以患者为中心的新轨道 研究。