Feasibility of an Internet-based fertility and early pregnancy study in the U.S.

描述（由申请人提供）：关于孕前健康在生育和早孕丢失中所起作用的知识缺乏。进行前瞻性妊娠研究的经典方法是在孕前登记来回答这些问题，在招募工作方面是耗时的，而且执行起来很昂贵。该项目的目的是评估在美国开展一项基于互联网的前瞻性怀孕研究的可行性，该研究采用在尝试怀孕期间使用每日日记的黄金标准数据收集方法进行孕前登记。为了实现这一目标，我们将招募200名试图怀孕的育龄妇女，对她们进行长达12个月的跟踪调查，并对怀孕的妇女进行孕期跟踪调查。女性将使用电子数据采集工具StudyTRAX在线提交所有数据。可行性将通过以下指标进行评估：筛选符合条件的妇女人数、登记的妇女人数以及随时间使用日记的依从性。我们还将估计不孕症、妊娠和妊娠丢失的发生率，并比较参加以社区为基础的孕前前瞻性妊娠研究的妇女的人口统计数据。这个项目的数据将用于评估…的可行性

DESCRIPTION (provided by applicant): There is a dearth of knowledge regarding the role that preconception health plays in fertility and early pregnancy loss. Classical methods of conducting prospective pregnancy studies with preconception enrollment to answer these questions are time-consuming in terms of recruitment efforts and expensive to carry out. The purpose of this project is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment in the United States using the gold standard data collection approach of daily diaries during the trying to conceive period. We will accomplish this by enrolling 200 females of reproductive age who attempting to conceive and following them for up to 12 months and through pregnancy for those who become pregnant. Women will submit all data online using StudyTRAX, an electronic data capture tool. Feasibility will be assessed by measuring: the number of women who screen eligible, the number of women who enroll, and compliance with diary use over time. We will also estimate the incidence of infertility, pregnancy and pregnancy loss as well as compare the demographics of women who enroll to the demographics of women who participate in community-based prospective pregnancy studies with preconception enrollment. The data from this project will be used to assess the feasibility of launching a larger prospective pregnancy study that is appropriately powered to examine the impact of preconceptional lifestyle factors on the incidence of infertility and early pregnancy loss.