ANTIBIOTIC PROPHYLAXIS AT IUD INSERTION

放置宫内节育器时预防性使用抗生素

• 批准号: 2314591
• 负责人: GERALD S BERNSTEIN
• 金额: $ 38.96万
• 依托单位: LOS ANGELES REG FAMILY PLANNING COUNCIL
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-02-01 至 1995-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2314591
• 关键词: ANTIBIOTIC; PROPHYLAXIS; IUD; INSERTION

This contract provides support for a clinical trial whose overall objectives are: (1) to measure the ability of prophylactic antibiotics to reduce the risk of PID and other events requiring premature removal of the IUD, (2) to estimate incidence rates for PID and other events requiring IUD removal, and (3) to determine the side effects of the antibiotic used in the treatment. The investigation will be conducted in two parts: a preliminary study in which the protocol will be validated and the initial choice of antibiotic will be confirmed by microbiological studies of endometrial tissue for women requiring premature removal of their IUD, and a larger study in which the benefit of prophylactic antibiotics will be evaluated in a multi-center, randomized, double-blind study of 2000 women receiving an IUD as their choice for contraception. Study subjects will be obtained from the following sources for this study: Kaiser-Permanente Los Angeles, Kaiser-Permanente Woodland Hills, Planned Parenthood-World Population (Clinics at El Monte, Midtown Los Angeles, Santa Monica, and Sherman Oaks), and Los Angeles County Women's Hospital. The Contractor shall obtain information about the diagnosis and management of women who develop problems associated with IUD use that require removal of the device (subacute salpingitis, endometritis, endoparametritis, bleeding, or pelvic pain) and acquire information about participants who require treatment for acute pelvic inflammatory disease ()ID). The data collected shall be sufficient to determine whether the use of prophylactic antibiotics will be a valuable adjunct to the IUD-insertion procedure.

该合同为临床试验提供了支持 目标是：（1）测量预防性抗生素的能力 降低PID的风险和其他需要过早删除的事件 宫内节育器，（2）估计PID的发病率和其他需要宫内节育器的事件 去除，（3）确定使用的抗生素的副作用 治疗。 调查将分为两个部分： 初步研究将验证协议和初始研究 抗生素的选择将通过微生物研究证实 需要过早去除宫内节子女的女性子宫内膜组织， 一项更大的研究，预防性抗生素的益处将是 在2000名女性的多中心，随机，双盲研究中评估 接受宫内节育器作为避孕的选择。 研究科目将是 从以下来源获得本研究的来源：kaiser-permanente los 安吉利斯（Angemes），凯撒（Kaiser-Permanente）伍德兰山（Woodland Hills） 人口（位于埃尔·蒙特，中城洛杉矶，圣莫尼卡和 Sherman Oaks）和洛杉矶县妇女医院。 承包商 应获得有关妇女诊断和管理的信息 开发与宫内节育器使用相关的问题，需要拆除设备 （亚急性盐炎，子宫内膜炎，内脑炎，出血或骨盆 疼痛）并获取有关需要治疗的参与者的信息 急性骨盆炎症疾病（）ID）。 收集的数据应为 足以确定使用预防性抗生素是否会 IUD插入程序的有价值的辅助手段。