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A NOVEL ORAL CONTRACEPTIVE INITIATION METHOD

一种新型口服避孕药启动方法

基本信息

批准号：
6163559
负责人：
PATRICIA MURPHY
金额：
$ 8.53万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2000
资助国家：
美国
起止时间：
2000-09-12 至 2001-09-11
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6163559
关键词：
Hispanic Americans behavioral /social science research tag clinical research clinical trials family planning female human subject human therapy evaluation menstrual cycle oral contraceptives outcomes research therapy compliance women's health

项目摘要

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.

描述（改编自申请人的描述）：在美国，近一半的怀孕在受孕时是意外的，超过80%的青少年怀孕是意外的。的主要原因是没有使用有效的避孕药具。口服避孕药这是最有效的方法之一，但即使开了处方，怀孕率仍然很高。这主要与不使用药丸有关（包括中止和从未开始）。多达24%的寻求口服避孕药的年轻妇女从未开始使用。因为开始口服避孕药的常规说明要求等待下一个月经期，可能会因月经不调而出现启动动力减退或在下次月经前怀孕。拟议的研究是一项试点评估，旨在产生样本量，受试者的招募和保留，以及大型一项比较传统口服避孕药启动的随机试验一种叫做快速启动的创新方法。通过这一创新方法，妇女开始服用口服避孕药在任何时候，在她的月经周期时，她有动机开始避孕。在计划随机试验，避孕持续和中止，相关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项为期一年的努力，以产生估计的入学率，失访和发生相关结局，包括妊娠和避孕中止。该试点项目还将评估三个不同层次的患者激励措施，以招募和完成后续采访。这些数据将用于估计样本量，更大规模随机试验的能力和预算。