跳至主要内容
临床试验/NCT01904669
NCT01904669已完成不适用

Prospective Evaluation of the Elements of Pregnancy Study

Courtney D.Lynch, PhD MPH1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
161
试验地点
1
主要终点
Number enrolled

研究概览

简要总结

The purpose of this study is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment with women completing daily journals for up to 12 months while trying to conceive and weekly through pregnancy if it occurs.

详细描述

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. Feasibility will be assessed by measuring: the number of women who screen eligible, the number of women who enroll, and compliance with journal 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Ages 18-44
  • In a stable relationship
  • Sexually active with a male partner
  • Reliable daily access to the Internet

排除标准

  • Woman or her partner has a known fertility problem
  • Trying to conceive for three or more months.

结局指标

主要结局

Number enrolled

时间窗: One year

次要结局

  • Completeness of data collection(Following 9-21 months of data collection)

研究者

发起方
Courtney D.Lynch, PhD MPH
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Courtney D.Lynch, PhD MPH

Assistant Professor

Ohio State University

研究点 (1)

Loading locations...

相似试验