RCT of a Novel Oral Contraceptive Initiation Method

描述(申请人提供)：接受者的怀孕率很高 尽管这种方法很有效，但口服避孕药的效果仍然很好。这些 怀孕是由于使用不当和过早停止使用 口服避孕药。在收到一份避孕药后没有开始避孕 处方药是一个很大的子类别。寻求口腔治疗的青少年比例高达25% 计划生育诊所的避孕药从来不会吃第一颗药。失败 开始口服避孕药可能是由于矛盾心理、困惑 开始说明，或由于干预怀孕。常规启动 口服避孕药的说明需要等到下一次月经 这可能会使客户面临怀孕的高风险。新方法 TO入门可能会改善延续和降低怀孕率 寻求口服避孕药的年轻女性。 为了提高启动率，我们开发了快速入门方法 患者在就诊期间直接吞下第一颗药丸 观察，然后继续每天服用避孕药，而不等待她的下一次 月经。妊娠试验、紧急避孕在临床上被用作 已注明。在一项对250名女性进行的初步研究中，那些吞下第一粒药丸的人 更有可能继续服用第二包药物而不是 接受传统启动指令的女性(调整后的CR2.74、2.74、 95%C.I.1.1-6.8)。我们还进行了一项随机试验，比较了90天 113名妇女的出血模式，她们被随机分配到快速入门组或 单相35微克EE OC的常规启动。104名女性完成了这项研究。 快速起跑和常规起跑的出血模式是相同的 有出色能力排除临床上重要差异的组。 为了进一步评估快速入门的有用性，我们建议使用多个条目 我们将招募2100名年龄在25岁以下的妇女的随机临床试验 好几年了。受试者将从3家公共资助的诊所招募 主要服务于西班牙裔和非裔美国人城市人口 社会经济地位。他们将完成基线、3个月和6个月 问卷调查。该试验的主要目的是评估口服避孕药。 续用率和怀孕率。我们预计在6个月内会有75%的低价。 主要的次要目标是评估 跨理论模型构建与采用和遵守 口服避孕药。我们还将评估双重方法在预防性病方面的应用。 口服避孕药的采用和依从性研究。我们还将 评估双重方法在研究人群中预防性病的使用情况。

Description (provided by applicant): Pregnancy rates are high among acceptors of oral contraceptives despite the effectiveness of the method. These pregnancies occur due to incorrect use and due to premature discontinuation of oral contraceptives. Failure to begin one contraceptives after receiving a prescription is a large subcategory. Up to 25% of adolescents who seek oral contraceptives from family planning clinics never take the first pill. Failure to begin oral contraceptives may occur due to ambivalence, confusion about starting instructions, or due to intervening pregnancy. Conventional starting instructions for oral contraceptives require waiting until the next menstrual period, which may leave the client at high risk of pregnancy. Novel approaches to initiation may improve continuation and decrease pregnancy rates among young women seeking oral contraceptives. In order to increase initiation rates we developed a quick start approach in which the client swallows the first pill during the clinic visit under direct observation and then continues daily pill use without waiting for her next menses. Pregnancy tests emergency contraception are used as clinically indicated. In a pilot study of 250 women, those who swallowed the first pill in the clinic were more likely to continue to their second pack of pills than women who received conventional starting instructions (adjusted CR 2.74, 2.74, 95% C.I. 1.1-6.8). We also carried out a randomized trial comparing 90-day bleeding patterns in 113 women who were randomized to quick start or conventional start of a monophasic 35ug EE OC. 104 women completed the study. Bleeding patterns were identical in the quick start and conventional start groups with excellent power to rule out clinically important differences. To further evaluate the usefulness of quick start we propose a multi-enter randomized clinical trial in which we will enroll 2l00 women aged less than 25 years. Subjects will be recruited from 3 publicly funded clinics that primarily serve Hispanic and African-American urban populations of low socio-economic status. They will complete a baseline, 3 month and 6 month questionnaire. The primary aim of the trial is to assess oral contraceptive continuation rates and pregnancy rates. We anticipate 75% low up at 6 months. The major secondary aim is to evaluate the predictive power of the Transtheoretical Model constructs relevant to adoption of and adherence to oral contraceptives. We will also assess dual method use for STD prevention in the study to adoption of and adherence to oral contraceptives. We will also assess dual method use for STD prevention in the study population.