A NOVEL ORAL CONTRACEPTIVE INITIATION METHOD

描述(改编自申请者的描述)：在美国， 近一半的怀孕是在怀孕时意外发生的，而且 超过80%的青少年怀孕是意外的。这个 主要原因是没有使用有效的避孕措施。口服避孕药是 这是最有效的方法之一，但即使在规定之后， 怀孕率仍然很高。这主要与未使用避孕药有关 (包括停止和永远不开始)。多达24%的 寻求口服避孕药的年轻女性从来不会开始服用。因为 常规指令开始口服避孕药的强制要求等待 下一次月经期间，由于动力减弱，可能永远不会开始。 或发生在下一次月经前的怀孕。 拟议的研究是一项试验性评估，旨在产生样本量， 科目注册和保留，以及大型 比较常规口服避孕药启动的随机试验 方法转化为一种名为快速入门的创新方法。凭借这一创新的 接近，妇女开始服用口服避孕药期间的任何时间 月经周期当她有动力开始避孕的时候。在计划中 随机试验，继续和停止避孕，联合 出血模式和意外怀孕将在两者之间进行比较。 组。 这项试点研究将是一年的努力，以产生注册人数的估计， 失访和相关结局的发生，包括怀孕 和停止避孕措施。这项试点还将评估 三种不同级别的患者激励措施以登记和完成 后续采访。然后这些数据将被用来估计样本大小， 接下来进行更大规模的随机试验的权力和预算。

DESCRIPTION (Adapted from applicant's description): In the United States, nearly half of all pregnancies are unintended at the time of conception, and more than eighty percent of pregnancies among teenagers are unintended. The main reason is non-use of effective contraceptives. Oral contraceptives are one of the most effective of methods, but even after they are prescribed, pregnancy rates remain high. This is primarily related to non-use of the pills (encompassing both discontinuation and never starting). As many as 24% of young women who seek oral contraceptives never start them. Because conventional instructions for starting oral contraceptives mandate waiting for the next menstrual period, never starting may occur due to waning motivation or to pregnancy that occurs before the next period. The proposed study is a pilot evaluation designed to produce sample size, subject enrollment and retention, and budget estimates needed for a large randomized trial to compare the conventional oral contraceptive initiation method to an innovative approach called Quickstart. With this innovative approach, a woman begins taking oral contraceptives at any time during her menstrual cycle when she is motivated to begin contraception. In the planned randomized trial, contraceptive continuation and discontinuation, associated bleeding patterns, and unintended pregnancies will be compared between the two groups. This pilot study will be a one year effort to produce estimates of enrollment, losses to follow-up, and occurrence of pertinent outcomes, including pregnancy and contraceptive discontinuation. This pilot will also assess the effects of three different levels of patient incentives to enroll and complete the follow-up interview. These data will then be used to estimate sample size, power and budget for the larger randomized trial to follow.