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的作用，缺乏相关知识。进行前瞻性妊娠研究的经典方法与孕前招募来回答这些问题是耗时的招募工作和昂贵的执行。本项目的目的是评估在美国进行一项基于互联网的前瞻性妊娠研究的可行性，该研究采用了在试图怀孕期间每日日记的金标准数据收集方法。我们将通过招募200名试图怀孕的育龄女性并对她们进行长达12个月的随访以及对怀孕者进行整个妊娠期的随访来实现这一目标。妇女将使用电子数据采集工具StudyTRAX在线提交所有数据。将通过测量以下指标评估可行性：筛选合格的女性人数、入组的女性人数以及随时间推移使用日记的依从性。我们还将估计不孕症、妊娠和妊娠丢失的发生率，并将入组的妇女的人口统计学资料与参加基于社区的前瞻性妊娠研究的孕前入组妇女的人口统计学资料进行比较。该项目的数据将用于评估 启动一项更大规模的前瞻性妊娠研究，该研究具有适当的把握度，以检查孕前生活方式因素对不孕症和早孕流产发生率的影响。 公共卫生相关性：关于孕前健康在生育和早孕流产中所起的作用，人们缺乏了解。进行前瞻性妊娠研究的经典方法与孕前招募来回答这些问题是耗时的招募工作和昂贵的执行。本项目的目的是评估在美国进行一项基于互联网的前瞻性妊娠研究的可行性，该研究采用了在试图怀孕期间每日日记的金标准数据收集方法。如果该项目被证明是成功的，这种进行这类研究的创新方法将为研究人员提供一种更有效和更具成本效益的方法，以更快的速度推动这一领域的科学发展。

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. PUBLIC HEALTH RELEVANCE: 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. Should the project prove successful, this innovative approach to conducting these types of studies will offer investigators a more efficient and cost-effective method of moving the science forward in this area at a more rapid rate.