INDOMETHACIN FOR ADJUVANT TOCOLYSIS

吲哚美辛辅助安胎

• 批准号: 6636719
• 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/6636719
• 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（根据申请人描述改编）：申请人：乔治A。 Macones，医学博士，硕士是本研究的主要研究者和候选人， 奖Macones博士是一位成熟的临床研究人员， 成功获得联邦临床研究赠款。 他有一条赛道 指导年轻调查员的记录，包括硕士学员， 产科/妇科临床流行病学，母胎医学研究员 住院医生和医学院学生Macones博士的目标是让 为孕妇的临床护理做出贡献，并成为一个 下一代以患者为导向的培训的组成部分 妇产科的研究人员。 研究计划：使用随机临床试验来检验假设， 吲哚美辛，当用于早产的辅助安胎时（即，在 对常规一线治疗无效的患者）， 降低新生儿主要并发症和死亡率。 拟议 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治疗 妊娠30周以下的辅助安胎。 患者将 本研究从医院的分娩病房招募 宾夕法尼亚大学宾夕法尼亚医院托马斯 杰斐逊大学医院和克里斯蒂娜护理健康服务。 患者 将对硫酸镁一线治疗“失败”的患者进行评估， 可能入选本随机临床试验。那些谁给 知情同意书将被纳入研究。 这项研究呼吁 两组共入组205例患者。患者将被随机分配至 接受吲哚美辛直肠栓剂（每6小时50 mg）或 相同外观的安慰剂栓剂48小时。完成后 无论是安慰剂或吲哚美辛治疗，病人的护理将在很大程度上， 主治医生的判断力。许多先前的安胎研究 使用不同的分娩延迟时间作为主要结局 measure. 我们认为这不是适当的主要终点，因为 安胎的最终目的是改善新生儿的结局。因此虽然 分娩延迟将作为次要终点进行分析，我们的主要结局 (on我们的样本量是基于）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 他的时间在这项活动。 他将在整个课程中继续这项活动 这项建议，并将重点放在学生在科学硕士课程 在宾夕法尼亚大学的临床流行病学，以及 获得NIH赞助的培训补助金支持的研究员， 生殖临床流行病学或走上以患者为中心的新轨道 Research.