Internet-based Study of Fertility and Early Pregnancy (PEEPS)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective Evaluation of the Elements of Pregnancy Study|
- Number enrolled [ Time Frame: One year ] [ Designated as safety issue: No ]
- Completeness of data collection [ Time Frame: Following 9-21 months of data collection ] [ Designated as safety issue: No ]Percentage of the study that the participant completed: baseline questionnaire (Y/N); daily trying to conceive journals (%); weekly pregnancy journals (%); and delivery information (%).
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Women who are trying to conceive
Women ages 18-44 without a history of fertility problems who are in a stable relationship with a male partner who have regular access to the Internet and have been trying to conceive <3 months.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01904669
|Contact: Courtney D Lynch, PhD, MPHfirstname.lastname@example.org|
|United States, Ohio|
|The Ohio State University College of Medicine||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Courtney D Lynch, PhD, MPH|
|Principal Investigator: Courtney D Lynch, PhD, MPH|